6. All genomic sequencing procedures and molecular
multianalyte assays (e.g., CPT codes 81410-81471), many
multianalyte assays with algorithmic analyses (e.g., CPT codes
81493-81599, 0004M-XXXXM), and many Proprietary Laboratory
Analyses (PLA) (e.g., CPT codes 0001U-XXXXU) are DNA or RNA
analytic methods that simultaneously assay multiple genes or
genetic regions. A physician shall not additionally separately
report testing for the same gene or genetic region by a
different methodology (e.g., CPT codes 81105-81408, 81479,
88364-88377). CMS payment policy does not allow separate
payment for multiple methods to test for the same analyte.
INTRODUCED NOVEMBER 22, 2018 FOR EFFECT JANUARY 1, 2019
DELETED BY CMS ON DECEMBER 12, 2018
7. A Tier 1 or Tier 2 molecular pathology procedure CPT
code shall not be reported with a genomic sequencing procedure,
molecular multianalyte assay, multianalyte assay with
algorithmic analysis, or proprietary laboratory analysis CPT
code where the CPT code descriptor includes testing for the
analyte described by the Tier 1 or Tier 2 molecular pathology
code.
8. If one laboratory procedure evaluates multiple genes
utilizing a next generation sequencing procedure, the laboratory
shall report only one unit of service of one genomic sequencing
procedure, molecular multianalyte assay, multianalyte assay with
algorithmic analysis, or proprietary laboratory analysis CPT
code. If no CPT code accurately describes the procedure
performed, the laboratory shall report CPT code 81479 (unlisted
molecular pathology procedure) with one unit of service. The
laboratory shall not report multiple individual CPT codes
describing the component test results. If a single procedure is
performed, only one HCPCS/CPT code with one unit of service may
be reported for the procedure.
9. Procedure-to-procedure edits bundling two Tier 1
molecular pathology procedure CPT codes describe procedures that
should not routinely be performed and reported together. For
example CPT code 81292 describes full sequence gene analysis of
MLH1, and CPT code 81294 describes duplication/deletion variant
gene analysis of MLH1. In evaluating a patient with colon
carcinoma (vs. constitutional genetic disorder), it may be
appropriate to perform duplication/deletion testing if the
disease variant(s) is (are) not identified by performing full
gene sequencing. The same principle applies to other code pair
combinations of testing for the same gene (e.g., 81295/81297,
81298/81300).
Wednesday, December 26, 2018
Thursday, December 13, 2018
December 2018 Parrish CGM Case Filed in Court
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Monday, December 10, 2018
Cloud Posting: Five Amazingly Complex SEP1 Documents
As of 2018.12.10, links to five amazingly complex SEP1 process documents.
Also in one ZIP file here.
This is a document file only.
I wrote actual essays on CMS SEP1 in August (first data release) and in November (performance of academic hospitals).
For a contrasting 2018 article by Walkey on the value of keeping it simple in Sepsis measures, here.
Also in one ZIP file here.
This is a document file only.
I wrote actual essays on CMS SEP1 in August (first data release) and in November (performance of academic hospitals).
For a contrasting 2018 article by Walkey on the value of keeping it simple in Sepsis measures, here.
63 page CMS measure guide
256 questions (73pp)
62 page webinar slides
4 page SEP1 tabular summary
4 page SEP1 flow chart diagram
Sunday, December 9, 2018
1997 Balanced Budget Act, Section 4554: Uniform CMS Lab Claims Policies
https://www.gpo.gov/fdsys/pkg/PLAW-105publ33/html/PLAW-105publ33.htm
SEC. 4554. IMPROVEMENTS <<NOTE: 42 USC 1395u note.>> IN ADMINISTRATION
OF LABORATORY TESTS BENEFIT.
(a) Selection of Regional Carriers.--
(1) In general.--The Secretary of Health and Human Services
(in this section referred to as the ``Secretary'') shall--
(A) divide the United States into no more than 5
regions, and
(B) designate a single carrier for each such region,
for the purpose of payment of claims under part B of title XVIII
of the Social Security Act with respect to clinical diagnostic
laboratory tests furnished on or after such date (not later than
July 1, 1999) as the Secretary specifies.
(2) Designation.--In designating such carriers, the
Secretary shall consider, among other criteria--
(A) a carrier's timeliness, quality, and experience
in claims processing, and
[[Page 111 STAT. 461]]
(B) a carrier's capacity to conduct electronic data
interchange with laboratories and data matches with
other carriers.
(3) Single data resource.--The Secretary shall select one of
the designated carriers to serve as a central statistical
resource for all claims information relating to such clinical
diagnostic laboratory tests handled by all the designated
carriers under such part.
(4) Allocation of claims.--The allocation of claims for
clinical diagnostic laboratory tests to particular designated
carriers shall be based on whether a carrier serves the
geographic area where the laboratory specimen was collected or
other method specified by the Secretary.
(5) Secretarial exclusion.--Paragraph (1) shall not apply
with respect to clinical diagnostic laboratory tests furnished
by physician office laboratories if the Secretary determines
that such offices would be unduly burdened by the application of
billing responsibilities with respect to more than one carrier.
(b) Adoption of National Policies for Clinical Laboratory Tests
Benefit.--
(1) In general.--Not later than January 1, 1999, the
Secretary shall first adopt, consistent with paragraph (2),
national coverage and administrative policies for clinical
diagnostic laboratory tests under part B of title XVIII of the
Social Security Act, using a negotiated rulemaking process under
subchapter III of chapter 5 of title 5, United States Code.
(2) Considerations in design of national policies.--The
policies under paragraph (1) shall be designed to promote
program integrity and national uniformity and simplify
administrative requirements with respect to clinical diagnostic
laboratory tests payable under such part in connection with the
following:
(A) Beneficiary information required to be submitted
with each claim or order for laboratory tests.
(B) The medical conditions for which a laboratory
test is reasonable and necessary (within the meaning of
section 1862(a)(1)(A) of the Social Security Act).
(C) The appropriate use of procedure codes in
billing for a laboratory test, including the unbundling
of laboratory services.
(D) The medical documentation that is required by a
medicare contractor at the time a claim is submitted for
a laboratory test in accordance with section 1833(e) of
the Social Security Act.
(E) Recordkeeping requirements in addition to any
information required to be submitted with a claim,
including physicians' obligations regarding such
requirements.
(F) Procedures for filing claims and for providing
remittances by electronic media.
(G) Limitation on frequency of coverage for the same
tests performed on the same individual.
(3) Changes in laboratory policies pending adoption of
national policy.--During the period that begins on the date of
the enactment of this Act and ends on the date the Secretary
first implements national policies pursuant to regulations
promulgated under this subsection, a carrier under such
[[Page 111 STAT. 462]]
part may implement changes relating to requirements for the
submission of a claim for clinical diagnostic laboratory tests.
(4) Use of interim policies.--After the date the Secretary
first implements such national policies, the Secretary shall
permit any carrier to develop and implement interim policies of
the type described in paragraph (1), in accordance with
guidelines established by the Secretary, in cases in which a
uniform national policy has not been established under this
subsection and there is a demonstrated need for a policy to
respond to aberrant utilization or provision of unnecessary
tests. Except as the Secretary specifically permits, no policy
shall be implemented under this paragraph for a period of longer
than 2 years.
(5) Interim national policies.--After the date the Secretary
first designates regional carriers under subsection (a), the
Secretary shall establish a process under which designated
carriers can collectively develop and implement interim national
policies of the type described in paragraph (1). No such policy
shall be implemented under this paragraph for a period of longer
than 2 years.
(6) Biennial review process.--Not less often than once every
2 years, the Secretary shall solicit and review comments
regarding changes in the national policies established under
this subsection. As part of such biennial review process, the
Secretary shall specifically review and consider whether to
incorporate or supersede interim policies developed under
paragraph (4) or (5). Based upon such review, the Secretary may
provide for appropriate changes in the national policies
previously adopted under this subsection.
(7) Requirement and notice.--The Secretary shall ensure that
any policies adopted under paragraph (3), (4), or (5) shall
apply to all laboratory claims payable under part B of title
XVIII of the Social Security Act, and shall provide for advance
notice to interested parties and a 45-day period in which such
parties may submit comments on the proposed change.
(c) Inclusion of Laboratory Representative on Carrier Advisory
Committees.--The Secretary shall direct that any advisory committee
established by a carrier to advise such carrier with respect to coverage
and administrative policies under part B of title XVIII of the Social
Security Act shall include an individual to represent the independent
clinical laboratories and such other laboratories as the Secretary deems
appropriate. The Secretary shall consider recommendations from national
and local organizations that represent independent clinical laboratories
in such selection.
Wednesday, November 28, 2018
FDA's Own Guidance to Issuing Guidance
For over a decade, quite a few legal scholars have commented on the FDA's propensity to issue policy as "guidance documents" rather than as regulation.
As noting in a newly published request for information on prescription drug software (83FR58574), FDA has a regulation which lays out its own rules for issuing these guidance documents. See 21 CFR 10.115.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=10.115
FDA has two types of Guidance Documents, Level 1 or Level 2. Level 1 sets out FDA interpretation of statute, regulation, or has complex scientific content. Any other guidance document is "Level 2."
The regulation was established by 64 FR 56477, 13pp, 9/19/2000, with a trivial amendment regarding a web link in 2018, 83 FR 13416, 3/29/2018.
As noting in a newly published request for information on prescription drug software (83FR58574), FDA has a regulation which lays out its own rules for issuing these guidance documents. See 21 CFR 10.115.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=10.115
FDA has two types of Guidance Documents, Level 1 or Level 2. Level 1 sets out FDA interpretation of statute, regulation, or has complex scientific content. Any other guidance document is "Level 2."
The regulation was established by 64 FR 56477, 13pp, 9/19/2000, with a trivial amendment regarding a web link in 2018, 83 FR 13416, 3/29/2018.
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Subpart B--General Administrative Procedures
| Sec. 10.115 Good guidance practices. |
(a) What are good guidance practices? Good guidance practices (GGP's) are FDA's policies and procedures for developing, issuing, and using guidance documents.
(b) What is a guidance document? (1) Guidance documents are documents prepared for FDA staff, applicants/sponsors, and the public that describe the agency's interpretation of or policy on a regulatory issue.
(2) Guidance documents include, but are not limited to, documents that relate to: The design, production, labeling, promotion, manufacturing, and testing of regulated products; the processing, content, and evaluation or approval of submissions; and inspection and enforcement policies.
(3) Guidance documents do not include: Documents relating to internal FDA procedures, agency reports, general information documents provided to consumers or health professionals, speeches, journal articles and editorials, media interviews, press materials, warning letters, memoranda of understanding, or other communications directed to individual persons or firms.
(c) What other terms have a special meaning? (1) "Level 1 guidance documents" include guidance documents that:
(i) Set forth initial interpretations of statutory or regulatory requirements;
(ii) Set forth changes in interpretation or policy that are of more than a minor nature;
(iii) Include complex scientific issues; or
(iv) Cover highly controversial issues.
(2) "Level 2 guidance documents" are guidance documents that set forth existing practices or minor changes in interpretation or policy. Level 2 guidance documents include all guidance documents that are not classified as Level 1.
(3) "You" refers to all affected parties outside of FDA.
(d) Are you or FDA required to follow a guidance document? (1) No. Guidance documents do not establish legally enforceable rights or responsibilities. They do not legally bind the public or FDA.
(2) You may choose to use an approach other than the one set forth in a guidance document. However, your alternative approach must comply with the relevant statutes and regulations. FDA is willing to discuss an alternative approach with you to ensure that it complies with the relevant statutes and regulations.
(3) Although guidance documents do not legally bind FDA, they represent the agency's current thinking. Therefore, FDA employees may depart from guidance documents only with appropriate justification and supervisory concurrence.
(e) Can FDA use means other than a guidance document to communicate new agency policy or a new regulatory approach to a broad public audience? The agency may not use documents or other means of communication that are excluded from the definition of guidance document to informally communicate new or different regulatory expectations to a broad public audience for the first time. These GGP's must be followed whenever regulatory expectations that are not readily apparent from the statute or regulations are first communicated to a broad public audience.
(f) How can you participate in the development and issuance of guidance documents? (1) You can provide input on guidance documents that FDA is developing under the procedures described in paragraph (g) of this section.
(2) You can suggest areas for guidance document development. Your suggestions should address why a guidance document is necessary.
(3) You can submit drafts of proposed guidance documents for FDA to consider. When you do so, you should mark the document "Guidance Document Submission" and submit it to Division of Dockets Management (HFA-305), 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. If you wish to submit the draft of a proposed guidance document electronically, submit it through https://www.regulations.gov at Docket No. FDA-2013-S-0610. It is only necessary to submit one copy.
(4) You can, at any time, suggest that FDA revise or withdraw an already existing guidance document. Your suggestion should address why the guidance document should be revised or withdrawn and, if applicable, how it should be revised.
(5) Once a year, FDA will publish, both in the Federal Register and on the Internet, a list of possible topics for future guidance document development or revision during the next year. You can comment on this list (e.g., by suggesting alternatives or making recommendations on the topics that FDA is considering).
(6) To participate in the development and issuance of guidance documents through one of the mechanisms described in paragraphs (f)(1), (f)(2), or (f)(4) of this section, you should contact the center or office that is responsible for the regulatory activity covered by the guidance document.
(7) If FDA agrees to draft or revise a guidance document, under a suggestion made under paragraphs (f)(1), (f)(2), (f)(3) or (f)(4) of this section, you can participate in the development of that guidance document under the procedures described in paragraph (g) of this section.
(g) What are FDA's procedures for developing and issuing guidance documents? (1) FDA's procedures for the development and issuance of Level 1 guidance documents are as follows:
(i) Before FDA prepares a draft of a Level 1 guidance document, FDA can seek or accept early input from individuals or groups outside the agency. For example, FDA can do this by participating in or holding public meetings and workshops.
(ii) After FDA prepares a draft of a Level 1 guidance document, FDA will:
(A) Publish a notice in the Federal Register announcing that the draft guidance document is available;
(B) Post the draft guidance document on the Internet and make it available in hard copy; and
(C) Invite your comment on the draft guidance document. Paragraph (h) of this section tells you how to submit your comments.
(iii) After FDA prepares a draft of a Level 1 guidance document, FDA also can:
(A) Hold public meetings or workshops; or
(B) Present the draft guidance document to an advisory committee for review.
(iv) After providing an opportunity for public comment on a Level 1 guidance document, FDA will:
(A) Review any comments received and prepare the final version of the guidance document that incorporates suggested changes, when appropriate;
(B) Publish a notice in the Federal Register announcing that the guidance document is available;
(C) Post the guidance document on the Internet and make it available in hard copy; and
(D) Implement the guidance document.
(v) After providing an opportunity for comment, FDA may decide that it should issue another draft of the guidance document. In this case, FDA will follow the steps in paragraphs (g)(1)(ii), (g)(1)(iii), and (g)(1)(iv) of this section.
(2) FDA will not seek your comment before it implements a Level 1 guidance document if the agency determines that prior public participation is not feasible or appropriate.
(3) FDA will use the following procedures for developing and issuing Level 1 guidance documents under the circumstances described in paragraph (g)(2) of this section:
(i) After FDA prepares a guidance document, FDA will:
(A) Publish a notice in the Federal Register announcing that the guidance document is available;
(B) Post the guidance document on the Internet and make it available in hard copy;
(C) Immediately implement the guidance document; and
(D) Invite your comment when it issues or publishes the guidance document. Paragraph (h) of this section tells you how to submit your comments.
(ii) If FDA receives comments on the guidance document, FDA will review those comments and revise the guidance document when appropriate.
(4) FDA will use the following procedures for developing and issuing Level 2 guidance documents:
(i) After it prepares a guidance document, FDA will:
(A) Post the guidance document on the Internet and make it available in hard copy;
(B) Immediately implement the guidance document, unless FDA indicates otherwise when the document is made available; and
(C) Invite your comment on the Level 2 guidance document. Paragraph (h) of this section tells you how to submit your comments.
(ii) If FDA receives comments on the guidance document, FDA will review those comments and revise the document when appropriate. If a version is revised, the new version will be placed on the Internet.
(5) You can comment on any guidance document at any time. Paragraph (h) of this section tells you how to submit your comments. FDA will revise guidance documents in response to your comments when appropriate.
(h) How should you submit comments on a guidance document? (1) If you choose to submit comments on any guidance document under paragraph (g) of this section, you must send them to the Division of Dockets Management (HFA-305), 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
(2) Comments should identify the docket number on the guidance document, if such a docket number exists. For documents without a docket number, the title of the guidance document should be included.
(3) Comments will be available to the public in accordance with FDA's regulations on submission of documents to the Division of Dockets Management specified in 10.20(j).
(i) What standard elements must FDA include in a guidance document? (1) A guidance document must:
(i) Include the term "guidance,"
(ii) Identify the center(s) or office(s) issuing the document,
(iii) Identify the activity to which and the people to whom the document applies,
(iv) Prominently display a statement of the document's nonbinding effect,
(v) Include the date of issuance,
(vi) Note if it is a revision to a previously issued guidance and identify the document that it replaces, and
(vii) Contain the word "draft" if the document is a draft guidance.
(2) Guidance documents must not include mandatory language such as "shall," "must," "required," or "requirement," unless FDA is using these words to describe a statutory or regulatory requirement.
(3) When issuing draft guidance documents that are the product of international negotiations (e.g., guidances resulting from the International Conference on Harmonisation), FDA need not apply paragraphs (i)(1) and (i)(2) of this section. However, any final guidance document issued according to this provision must contain the elements in paragraphs (i)(1) and (i)(2) of this section.
(j) Who, within FDA, can approve issuance of guidance documents? Each center and office must have written procedures for the approval of guidance documents. Those procedures must ensure that issuance of all documents is approved by appropriate senior FDA officials.
(k) How will FDA review and revise existing guidance documents? (1) The agency will periodically review existing guidance documents to determine whether they need to be changed or withdrawn.
(2) When significant changes are made to the statute or regulations, the agency will review and, if appropriate, revise guidance documents relating to that changed statute or regulation.
(3) As discussed in paragraph (f)(3) of this section, you may at any time suggest that FDA revise a guidance document.
(l) How will FDA ensure that FDA staff are following GGP's? (1) All current and new FDA employees involved in the development, issuance, or application of guidance documents will be trained regarding the agency's GGP's.
(2) FDA centers and offices will monitor the development and issuance of guidance documents to ensure that GGP's are being followed.
(m) How can you get copies of FDA's guidance documents? FDA will make copies available in hard copy and, as feasible, through the Internet.
(n) How will FDA keep you informed of the guidance documents that are available? (1) FDA will maintain on the Internet a current list of all guidance documents. New documents will be added to this list within 30 days of issuance.
(2) Once a year, FDA will publish in the Federal Register its comprehensive list of guidance documents. The comprehensive list will identify documents that have been added to the list or withdrawn from the list since the previous comprehensive list.
(3) FDA's guidance document lists will include the name of the guidance document, issuance and revision dates, and information on how to obtain copies of the document.
(o) What can you do if you believe that someone at FDA is not following these GGP's? If you believe that someone at FDA did not follow the procedures in this section or that someone at FDA treated a guidance document as a binding requirement, you should contact that person's supervisor in the center or office that issued the guidance document. If the issue cannot be resolved, you should contact the next highest supervisor. You can also contact the center or office ombudsman for assistance in resolving the issue. If you are unable to resolve the issue at the center or office level or if you feel that you are not making progress by going through the chain of command, you may ask the Office of the Chief Mediator and Ombudsman to become involved.
[65 FR 56477, Sept. 19, 2000, as amended at 83 FR 13416, Mar. 29, 2018]
##
Tidbit
See FDA's announcement of a new program to have pre pivotal trial meetinss with FDA about innovative (eg Bayesian) designs. August 2018. https://www.gpo.gov/fdsys/pkg/FR-2018-08-30/pdf/2018-18801.pdf
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Tuesday, November 27, 2018
CY2016 CMS 81479 Billing by Lab
Wednesday, November 21, 2018
MolDx Gene Panel Alert: Archive Version 11/18/2018
https://www.palmettogba.com/palmetto/moldx.nsf/docscat/MolDx%20Website~MolDx~Browse%20By%20Topic~General~Molecular%20Test%20Panel%20Edit%20Alert%20(M00101%20V4)
Molecular Test Panel Edit Alert (M00101, V4)
MolDX CPT code range affected: 81161-81408
Test Panel Definition: A predetermined set of medical tests composed of individual laboratory tests, related by medical condition, specimen type, frequency ordered, methodology or types of components to aid in the diagnosis/treatment of disease.
Palmetto considers the performance of multiple molecular biomarkers, regardless of whether the test requisition lists the tests as a panel or individually, and completed on a single sample to be a 'panel' of tests. Therefore, each panel should be registered and billed with a single CPT code and a unique MolDX identifier. Based on data analysis of MolDX claims, labs are submitting multiple biomarker 'panels' as individual tests similar to the submission of the previous stacking codes.
Example: A lab receives a patient specimen and performs the following tests:
- CPT code 81225-CYP2C19, cv
- CPT code 81240-F2, 20210G>A
- CPT code 81241-F5, Leiden
The panel of three tests listed above should be registered and claims submitted with CPT code 81479 and a single MolDX ID. If the lab also performs one of the three panel’s biomarkers on patient specimens, each biomarker must also be registered and receive a unique ID to submit on claims when only that biomarker is performed. Again, a single CPT code should be billed with a unique ID.
To correct this example, the lab must register four tests and receive identifiers for MolDX claim submission:
Test #
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Test Name
|
Biomarkers
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ID
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CPT Code
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|---|---|---|---|---|
1
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Clotting Test Panel
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CYP2C19, cv
F2, 20210G>A
F5, Leiden
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Z1234
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81479
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2
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CYP2C19
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CYP2C19, cv
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Z5678
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81225
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3
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F2, 20210G>A
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F2, 20210G>A
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ZA234
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81240
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4
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F5, Leiden
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F5, Leiden
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ZA567
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81241
|
Labs should register all panels and obtain a unique MolDX identifier for each panel. If a lab does NOT perform single biomarker tests, they must notify the registry of this registration error.
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Monday, November 5, 2018
How to Make a Lift/Drop Waterfall Chart with Regular Powerpoint Tables
I've seen elaborate waterfall charts that add and subtract financials in sequence but I've never made one myself. A master deck from a client showed how.
Basically, it's a stacked bar chart where many of the bottom level bars are "white" or "transparent." Add or subtract bars "float" above the transparent barstack below them. Easy.
Below, the first bar is 340 and blue. The next bar is a stacked bar with "340" in white or transparent, and then, a green bar for 30 floating on top of that. To show a negative, for example, you'd have used instead a bar of 310 for the second bar and a red bar of 30 on top of it.
Note that these bars are slightly spaced (gap toothed) because they have a Format Data Series option of 20% gap width.
I think the numbers floating on top are related to the "Format Data Labels" option but I'm not sure exactly how; I think by checking "Format Data Labels / Label Options / Label Contains / Value."
Note that the example has a truncated left axis (from 300 to 390).
Basically, it's a stacked bar chart where many of the bottom level bars are "white" or "transparent." Add or subtract bars "float" above the transparent barstack below them. Easy.
Below, the first bar is 340 and blue. The next bar is a stacked bar with "340" in white or transparent, and then, a green bar for 30 floating on top of that. To show a negative, for example, you'd have used instead a bar of 310 for the second bar and a red bar of 30 on top of it.
 |
| click to enlarge |
I think the numbers floating on top are related to the "Format Data Labels" option but I'm not sure exactly how; I think by checking "Format Data Labels / Label Options / Label Contains / Value."
Note that the example has a truncated left axis (from 300 to 390).
Wednesday, October 31, 2018
October 2018: Milken Institute Conversation with Scott Gottlieb
Speakers
Guest
Scott Gottlieb, Commissioner,
U.S. Food and Drug Administration
Moderator
Tanisha Carino, Executive
Director, FasterCures, Milken Institute
Tanisha
Carino: Hello, everyone. I'm
delighted to be here with Commissioner Gottlieb. For those of you that don't
know Scott ... Can I call you Scott?
Scott
Gottlieb: Yes.
Tanisha
Carino: Scott is a
physician, a policy wonk, an investor, an industry expert, former investor, a
cancer survivor, a husband, and a father. Now, he's the 23rd Commissioner of
food and drugs. Over the last 18 months ... This is your third tour of FDA?
Scott
Gottlieb: That's right.
Yeah. Yep.
Tanisha
Carino: In your first year,
you approved more new drugs, more generics. You also have had a very aggressive
public health agenda that included limiting nicotine levels, regulating
e-cigarettes, getting dangerous opioids off of the market. You're responsible
for the fact that if I go to a McDonald's, I know how many calories I eat with
a Big Mac.
Tanisha
Carino: For those of you
that haven't been following the news as closely, this past week Scott was voted
Time Magazine's one of 50 most influential leaders. You are accomplished, you're
influential, and people also think you're a fashionista.
Tanisha
Carino: For those of you
that don't follow our commissioner on Twitter, I highly suggest that you do so.
Because I knew I was going to be next to him on stage today, I made sure to
absolutely dress up my shoes today. I hope that I'm beating Scott at his sock
game today.
Tanisha
Carino: Let's jump in
because I know we don't have that much time with you. Over the course of the
last 24 hours, we've heard a lot about the future of health. If there is one
thing that has been a consistent theme throughout this summit, it's been that
the greatest disruption and the greatest source of innovation is the idea of
being patient-centered and really listening to what patients actually need.
Tanisha Carino: You've been on three different
tours of the FDA. Over the last few years, the FDA has been an incredible
leader of what it means to be patient-centered. I'd love for you to first start
by reflecting on how that's changed and what it means to the FDA and is this
really a values-oriented strategy or how you think about that.
Scott
Gottlieb: I think it
certainly is a values strategy. I know Janet touched on some of those issues
today about the changing orientation of the agency and the sense that the clinicians
really go to the house that their medical officers working in medical endeavors
in the pursuit of trying to improve outcomes of patients but I think we've done
discrete things to try to incorporate patient perspectives into our regulatory
decision making and inform our policy making, things like patient-reported
outcomes, building them in as measures and as the outcomes in clinical trials.
Scott
Gottlieb: But I think that
the other big opportunity, in addition to trying to find discreet ways to bring
patients into the dialogue, bring patient perspectives into the regulatory
decision making process is some of the tools that we were going to have
available to us to actually measure things that are meaningful to patients.
Scott
Gottlieb: We're going to be
promulgating in a couple of weeks a platform for how you can incorporate
digital health tools in the context of the approval of a drug. You could get
approval for a drug digital health tool delivery system, if you will. These are
going to be digital tools that could help with patient compliance, could
measure patient symptoms, or maybe could measure outcomes, measure physical
performance in a way that it could be used for either post-market surveillance,
post-market commitments, or future regulatory decision making, trying to
collect information that can be used for supplement mental indications.
Scott
Gottlieb: Right now, for
example, we use a six-minute walk test as a standard measure of physical
performance for a lot of clinical trials particularly for neurodegenerative
diseases in children, mucopolysaccharide diseases. That's not a really great
measure all the time of physical performance. Someone can come to the doctor
and just have a bad day. They come in once a month or once every two weeks for
a checkup and being measured on a walk test on a treadmill.
Scott
Gottlieb: We know that, we
have watches now that could potentially measure our physical performance on a
daily basis and better track if we're improving, if our physical performance is
improving. Obviously these need to be validated, these kinds of tools, but
those are the opportunities I think that we're going to have and our goal is to
try to build up out regulatory frameworks that enable these tools to come to
market.
Scott
Gottlieb: An example of
looking at digital tools that could be used in conjunction with drugs, what
we're looking to do there is incorporate the digital tools into the product
labeling in a way that they could be regulated in the post market as part of
the promotional labeling, as opposed to just having to be regulated as a
pre-market medical devices and undergo pre-market review. This is going to help
facilitate the development of more of these kinds of tools.
Tanisha
Carino: Scott, for us, we
had a session yesterday on the future of data disrupting health. One of the aha
moments was the transition from having what is unstructured data or some people
called it dirty data into data that is going to be meaningful and useful. It
sounds like this is the type of innovation from a regulatory perspective that's
going to create more understanding of how to integrate this. Is that a fair way
of understanding the path that you all are on?
Scott
Gottlieb: I think it is. I
think that if you look at a lot of the outcomes, there's objective outcomes
like tumor shrinkage, objective outcomes in oncology but a lot of the measures
that we use in clinical development measure physical performance or measure how
patients experience symptoms.
Scott
Gottlieb: I think that
there was ways to incorporate technology that's going to allow us to gather
that information in a much more objective fashion more reliably, perhaps more
quickly so that if you have better tools that are more sensitive for measuring
change in physical symptoms, of physical performance, you can potentially get
an answer more quickly than if you have a tool that's measuring physical
performance that's highly variable so you need a larger data set, you need more
patients to account for the variability statistically. You need to follow them
for long because you don't have a sensitive tools, so in order to measure a
decline in function you need to you need to follow patients longer.
Unfortunately, you're watching someone decline in function in the context of
the clinical trial in order to prove something work.
Scott
Gottlieb: I think that
we're going to have more of these opportunities. If you look at what we did in
Alzheimer's where we change the guidance to, before, in order to have a drug
approved for Alzheimer's, you had to both have an effect on cognition as well
as performance. The notion being that you had to decline enough in cognition so
that it had an effect on your physical performance but the problem was, by the
time your cognition declined in that setting, you were pretty advanced in the
disease. By the time it declined enough to affect your physical performance,
you were pretty advanced in the disease. It mitigated against trying to develop
a drug for early Alzheimer's before the decline in cognition had an effect on
physical performance. We put out new guidance that said that you only need to
now in certain settings hit on cognition if you can measure changes in
cognition.
Scott
Gottlieb: One of the
things that facilitated our ability to do that was the advent of better tools for
measuring changes in cognition, not just better surveys that we used to measure
cognition but better tools for actually collecting the data where we now had
digital platforms for doing that, so you can collect them in a more reliable
fashion and have better quality control in terms of how you collecting that
information.
Tanisha
Carino: That's great. One of
the questions that, for faster cures, we've been focused on this idea of
patient engagement. We've been incredibly impressed with the FDA has done in
terms of all of its listening sessions it's held over the last few years. Now,
there's been a real surge in activity by almost every group that's out here
from a patient perspective and wanting to really own the future of what is
meaningful to them.
Tanisha
Carino: When you think about
your review staff and you think about the talent that you have at the FDA and
what's happened, do you see a meaningful difference and how they're really
considering the patient and how has it really changed the culture even within
the FDA?
Scott
Gottlieb: I think the
bottom line is it has changed the culture, the engagement, and the formal
structures that we put in place to try to bring patients into the process has
changed the culture of the agency.
Scott
Gottlieb: The other thing
we're trying to do with how we're restructuring the Office of New Drugs and the
review process itself is, a medical reviewer right now at FDA does a lot of
different things. They're not just doing clinical evaluation. They're not just
trying to develop new guidance and be thought leaders within their fields.
They're also, when the review package comes in to the FDA right now, they're
the ones taking the raw data and putting it in charts and analyzing the data in
statistical packages.
Scott Gottlieb: A medical officer shouldn't be
doing that. We should be having experts who are expert in data analytics doing
the initial analysis. We should have people who know how to format data, doing
the formatting and assembling into standardized presentations that then the
medical reviewer can use.
Scott
Gottlieb: What we're
trying to do with the reform that we're undertaking with the Office of New
Drugs is actually free the Medical Review staff and create more cross-agency
functions to do some of the technical aspects of the review process so that the
clinical officers can be a clinical house staff so that they can focus on the
clinical portion of the review so that they have more time to engage with
patients and so that they have more time to engage as thought leaders within
their fields.
Scott
Gottlieb: That's the key
element of what we're doing with the OND reform. I literally talked to
reviewers who will explain to me that they spent a whole day trying to assemble
data into a chart. There's a lot of people who know how to do that. Most of
them are under the age of 25. We shouldn't have a physician doing that.
Scott
Gottlieb: We're trying to
create these kinds of cross-function units to do some of the structural work
the analytical work that goes into the review. I think that's going to also ...
We estimated that it's going to improve productivity by about 20% but what
we're trying to do with that improved productivity now is facilitated
development of many more disease-specific guidances. We committed to put out
hundreds and do disease-specific guidances and also free our house staff to
engage more with the external community. You're starting to see that now but
that's the long-term vision.
Tanisha
Carino: I remember the days
when you would never be able to meet or review stuff. Now, you have them
spending all day at meetings about what's meaningful to patients in all sorts
of different ways.
Tanisha
Carino: I want to touch on
the fact that you spent 15 years as a resident fellow at the American
Enterprise Institute. There's a long body of writing that you've done on the
role of government in creating a transparency and being a force in creating
efficient markets. One of the keys to transparency is the availability of
information.
Tanisha
Carino: As the FDA Commissioner,
how do you feel like you've moved forward in terms of the transparency the
agency can have to be a good steward of what's happening in public health and
inform the public of what's happening?
Scott
Gottlieb: I actually
published 826 articles. I know that only because the Senate collected them all
at my confirmation hearing. The best part of my confirmation hearing was when I
handed them all in, I had a hand in a list of every article I ever published. I
inadvertently, and it was completely inadvertently, left three off and they
found them.
Tanisha
Carino: Now, you have the
exact number of what was that?
Scott
Gottlieb: Now, I have them
all.
Scott
Gottlieb: One of the
things that I talked about, the reform of the new drug approval process. One of
the things that we're doing right now is creating a more structured review.
You're going to start to see this first on the safety side in terms of how we
review safety data coming into the agency. What we're trying to do is across
all the different therapeutic divisions look at data the same way so when data
comes in, we're going to have those cross-functional units analyze the data in
a similar fashion, assemble the data in charts that are preferred.
Tanisha
Carino: Paper charts?
Scott
Gottlieb: No. Digital
charts that are preferred to FDA. What's facilitating this is the
fully-electronic submission of data right now. We're now going to make more of
the bottom line data from the review process available publicly. We started
that as a pilot. Companies have been opting into it but we're going to try to
make more of the bottom line data available as part of the review memo that
gets ultimately promulgated.
Scott
Gottlieb: But part of what
a structure review is going to enable is that at the end of the review process,
when a drug's approved, we're going to be able to make information about how
and why we made our decision available much more quickly, within probably 48
hours. Then, it's going to be more of a problem-
Tanisha
Carino: Just for context for
the audience, what is it now? Is 48 hours exponentially faster?
Scott
Gottlieb: Yes. It's much
faster. It could take weeks until you have that level of detail. There's some
initial information for public but in terms of the level of detail we're going
to make available, it's going to be much more quickly.
Scott
Gottlieb: The review memo,
so right now, the review process is you have a lot of people who are
consultants to the review process, each developing their own review memos. It's
a lot of cut and paste. If you look at different review memos as part of the
standard review package, it's a lot of cut and paste. What we're going to do is
have the different disciplines that are part of the review teams collaborating
around one digital review template, much like you probably all do in your
corporate jobs. We don't do that right now at FDA. We're going to have one
review memo. The review memo's going to be more of a problem based review memo.
What were the questions what were the critical questions we needed to answer as
part of making a decision and how did we resolve those questions?
Scott
Gottlieb: It's going to be
a much more accessible document I think to providers to patients to people on
the outside who want to review our work.
Tanisha
Carino: This will all be, at
least part of it in the public domain [crosstalk 00:13:53]?
Scott
Gottlieb: This is all
going to be in the public domain and the place where we're implementing this
approach first is around the safety portion of the review.
Tanisha
Carino: Mm-hmm (affirmative).
In your past budgets, you've put in for a knowledge management system. Is this
related knowledge management? Tell us a little bit about what that request
really is about and how that plays into the notion of predictability or
transparency.
Scott Gottlieb: Right. Right now, if someone
came to me and asked me how many times has FDA approved an oncology drug based
on a measure of effectiveness against this specific biomarker, the way I would
answer that question is I'd try to assemble everyone in a room to ask them. I'd
usually start with Bob Temple because he's been there the longest.
Scott
Gottlieb: We don't have
the ability to query our own decisions. We don't have the ability to look
across our own decisions to try to extract from them where we made decisions
based on common elements. All of our historical precedents is embedded in
people's minds. Literally, when we're developing new guidance documents, where
we're trying to consolidate collected knowledge over time, those are developed
by bringing together big teams of people and trying to query them.
Scott
Gottlieb: What we wanted
to do is develop a knowledge management system that allows us to incorporate
our own precedent and query it in a real-time fashion. This is something that a
lot of knowledge enterprises have. We don't have it. We don't have it anywhere
in the agency right now. We have a Google search bar. We want to develop this
kind of a system. The budget request that we had in 2019 has a specific request
for this. The requests were made in 2020 as well.
Tanisha
Carino: How urgent of an
issue is this? Are you like most federal agencies that's looking at a tsunami
of retirement. Now, you don't have those people in the room?
Scott
Gottlieb: I'm worried
about retirements because, like a lot of federal agencies, we have a cohort of
people who came aboard at a certain time. A lot of our leadership is reaching
retirement age but I'm not worried about retirements from this perspective. I
think this is something that a lot of government agencies don't have but most
government agencies are pass-through agencies, where we pass through very few
dollars. Our money's spent at FDA developing intellectual capital and
evaluating information.
Scott
Gottlieb: We're an
information enterprise. The fact that we don't have the ability to catalog and
easily query our own decisions is a challenge especially as those decisions
become more complex and we want to bring regulatory consistency across how we
make decisions and ultimately if we built this tool, this would be a publicly
accessible tool. There's companies on the outside, database companies that make
a living developing databases that you can query around specific aspects of
regulatory decision making. No one's built anything that would be a
comprehensive tool on the order of what we want to develop.
Tanisha
Carino: For product sponsors
as well as just patients, I would think that that's something that
predictability is something we count on.
Scott
Gottlieb: Yeah. The other
thing is, on an ad-hoc basis, we, for example, will on certain safety reviews,
consolidate safety datasets across multiple product reviews. This is a very
touchy issue because companies claim that their data from their packages is
commercial confidential information. If we're consolidating that into a data
set to make regulatory decision making across a class, we need to be very
mindful how we do that in a way that doesn't abrogate their intellectual
property in those respects but we do do it. People know we've done it. We've
been public about it but when we do it. those data sets aren't available
publicly.
Scott
Gottlieb: Where we are
making decisions by putting queries against a consolidated data set that people
on the outside can't query to see if we've made the right decision or to
adjudicate their own decisions. That's not an enviable position. If we're going
to be developing that kind of intellectual capital and property and make
decisions based on it, we need to make that available.
Scott
Gottlieb: This is another
thing that, if you had a knowledge management system and help facilitate the
consolidation of this information and make it publicly available, it's another
opportunity that we'd be able to provide.
Tanisha
Carino: That's great. For
those of you that don't often listen to the FDA Commissioner, one of the most
important points to make is that Scott and his agency actually regulate, is it
20 cents on every dollar spent so 20% of the economy is regulated in some
[formal way 00:18:33]?
Scott
Gottlieb: It's a growing
20%.
Tanisha Carino: Mm-hmm (affirmative). Tell us.
There are all sorts of new areas of science. You just talked about areas that
you're in selling gene-based therapies we've talked about. When people say
you're moving towards a risk-based approach for a regulation, what does that
mean and how are you thinking about how the regulatory frameworks keep up with
the speed of the science?
Scott
Gottlieb: I think we've
always talked about trying to have a risk-based approach to regulation. I think
when we think about that, that means trying to apply our regulatory tools in
the areas of highest risk. The most palpable place to get a sense of what it
means to be a risk-based system is in the post-market setting when you're doing
foreign inspections or inspections of manufacturing facilities.
Scott
Gottlieb: We inspect on
the basis of risk and we have models to identify facilities that we think
represent more risk based on where they're located, past history, the kinds of
products they're manufacturing, what we found on past inspections, what we know
about the proprietors of those facilities. We will go into certain facilities
more often than other facilities. Some facilities we won't inspect on a regular
schedules. Others we will. That's a risk-based model.
Scott
Gottlieb: If you look at
the Department of Agriculture, and this isn't to cast aspersions on my
colleagues at the USDA, but the way they inspect meat and poultry is they have
an inspector in every plant. We don't put an inspector physically in every
plant. We go into facilities based on risk models. When we inspect those
facilities, we're looking at things based on knowledge about where the points
are that could create risk to consumers. That's the essence of what it means to
be a risk-based model.
Scott
Gottlieb: I think, as we
advance those approaches, the opportunities come from having more information
to better target how we do what we do.
Tanisha
Carino: Tell us how that
philosophy has permeated even in things like your digital health strategy or
things like cell and gene-based therapies.
Scott
Gottlieb: Yeah. With
respect to digital health, I think one of the things that marks this time in
science and the regulatory challenges we face is that we are facing the advent
of entirely new areas of technology and innovation where the old regulatory
models don't apply real well when it comes to gene therapy, when it comes to
regenerative medicine, when it comes to digital health tools, laboratory tests.
If we tried to retrofit the existing regulatory paradigm onto these new areas,
we would stifle innovation. In some cases it's going to require us to seek new
legislative authority. You saw us provide about 70 pages of technical
assistance to Congress around what we think would be an optimal approach to the
regulation of laboratory-developed tests and diagnostics. In digital health, I
think that that's a very palpable example where he had to come up with a new
regulatory paradigm for how we would approach that.
Scott
Gottlieb: Digital health
tools are highly iterative. You're trying to make constant changes to them, to
iterate them to improve those tools. You think about an app on your phone or on
your smartwatch. If we required companies to come in and file five 10K
supplement every time they wanted to push out an update on a medical app, it
just wouldn't happen. We've taken what we're calling a firm-based approach the
regulation of lower risk digital health tools, where tools that meet the
definition of being a medical device and are subject to FDA's regulation,
rather than regulating each specific product, what we're going to do is
validate the underlying architecture of the software and allow firms that meet
certain requirements in terms of their own SOPs to come to market with new
products and new iterations of their existing products without requiring
pre-market clearance each time. They'll be subject to post-market evaluation.
Scott
Gottlieb: But when you
look at the level of validation that some of these companies are engaging and I
don't want to be company-specific but I've seen what some of these companies
do. They're undertaking an enormous amount of validation. If we can go and
inspect them, see their SOPs, understand the level of validation that they're
requiring before they put their products in the market and it's an otherwise
low-risk product, we can allow them to go to market and just be subject to
post-market exercise of regulation.
Scott
Gottlieb: If you look at
the Consumer Product Safety Commission, this is how they regulate. They put out
standards. People manufacture products subject to the standards. When a
problem's identified in the marketplace, they issue a recall. They could take
other remedies.
Scott
Gottlieb: There's very few
things in commerce that are subject to pre-market approval where you need
pre-market approval before you can go to market with the product. Medical
products are one, pesticides, aircraft engines. It's not a long list of things
where you need the government's permission to be able to go to market. Putting
the app on my watch on that list, we need to decide whether that meets the
level of risk where we need to acquire that level of oversight. The answer has
been more recently no. We don't we don't need to apply that level of oversight
even if it's meeting the definition of being a medical device. We could think
differently about how we apply regulation.
Tanisha
Carino: Right. I want to
switch to the fact that FDA is now on track to approve more products than you
did last year, which was a record year, where you'd approve 46 products. About
40% of products, it's almost holding steady year-over-year, have been really
for orphan designations, orphan drugs.
Tanisha
Carino: Yesterday we had
Harvard economist Amitabh Chandra come to us and talk to us a little bit about
his research. One of the data points he gave us was that the public health
needs and where R&D pipelines are are not a match.
Tanisha
Carino: Just as an example
of that, in mental health, the burden of disease is 15%, whereas the R&D
pipeline is less than 2%. Knowing that FDA isn't the only actor and what's
needed for either pull or push incentives, what do you think is the role of the
FDA to re-energize the innovation that needs to happen in these large big
public health disease classes?
Scott
Gottlieb: On the issue of
the statistics, last year was a record year for the number of novel medical
devices we approved, novel drugs and generic drugs will probably break all
three records this year. We just approved the first new antiviral drug for flu
in 20 years. I think that now we might have now surpassed the record number of
approvals of all time. It's only October. We'll see how we do between now and
at the end the year.
Scott
Gottlieb: I have multiple
concerns in this realm. I have a concern that it's become too hard to innovate
in areas where there's so-called good enough generics and some of the primary
care areas. I think that there's been such a focus on significant unmet medical
needs that we've lost sight of the palpable public health improvement that
comes from something that provides increments of additional efficacy for
something that's an otherwise ordinary condition.
Scott
Gottlieb: If you could
shave 10 hours off of the common cold, when you aggregate 10 hours of relief
from the common cold over a population of tens of millions of people who are
going to get a cold each year, the overall public health impact of that could
be enormous and productivity improvements and things like that.
Scott
Gottlieb: I think that
we've we've lost sight of the public health gains that come with small
increments of improvement in therapeutics that treat otherwise common
conditions that aren't necessarily life-threatening but where the symptoms do
impact people's lives. It's become hard to run clinical trials in those
settings because the expectation of safety has grown over time. I think there
is nothing wrong with that.
Scott
Gottlieb: I always say
that if you gave me the choice between driving a 2002 Honda Accord with 200,000
miles on it or a 1980 Corvette that's been on cinder blocks and never driven,
has zero miles on it, I would take the 2002 Honda Accord because it's a safer
car. It has airbags. It has anti-lock brakes. It has dual suspension. I can go
on. If I get into things I don't understand but the expectation for safety has
grown over time. The regulatory process has built in more oversight to meet
those expectations. I think that that's appropriate. As technology gets better,
we should be using it to improve what our expectations are about both the
benefits and the risks of the products we take but that can't come at the
expense of creating inordinate hurtles.
Scott
Gottlieb: I think in some
therapeutic areas, the hurdles are very high right now. The clinical trial
requirements are very big. That's where you have to look at I think the kinds
of tools that can make it easier to collect information in a fashion that is
just as rigorous but perhaps less onerous, things like collecting information
through real world performance of people, every day measuring real world
performance of, to measure lung function, to measure physical performance,
things like that.
Scott
Gottlieb: I'm also worried
about, on the reimbursement side at the other end of that barbell, when you're
looking at the drugs targeted to rare diseases, I think we have a highly
nimble, highly innovative paradigm for drug development and medical product
development and an ossified paradigm for reimbursement. There are places where
I'm extremely worried that if we don't adapt the approach to reimbursement
soon, we may foreclose therapeutic opportunities.
Scott
Gottlieb: I was around and
you were around too when we didn't get the reimbursement for the
radiopharmaceuticals right. There were some good drugs at the time that worked
and they're not used anymore. We not fully destroyed but we really shrunk the
opportunity for radiopharmaceutical development in this country by underpaying
the hospitals and forcing them to lose money on the application of
radiopharmaceuticals.
Scott
Gottlieb: We're doing the
same thing with [Carty 00:28:17] right now. I think we have a window of
opportunity to think about how we're going to reimburse that appropriately.
There's things FDA can potentially do in terms of how we label the products but
we're going to need to think about what an appropriate reimbursement approaches
to some of these novel therapeutic areas if we want to see these sustained.
Tanisha
Carino: Many people observe
that you're one of the few commissioners that has been very vocal about payment
issues, drug pricing. Do you feel like that is something that is critical now
that you're advancing science, you're on the forefront of knowing what's in
pipelines, but the payer community by and large doesn't have the same point of
view or the capacity to really be that in deep on every scientific advancement.
Tanisha
Carino: What is the FDA's
role in bridging between the payers?
Scott
Gottlieb: I think I've
stuck to my knitting. I think that when you look at the issues of drug pricing.
There's product competition. There's price competition. When it comes to price
competition, you think about you know the reimbursement constructs that are
exercised by Medicare or how PBMs and health plans are organized. When you
think about product competition, you think about making sure there's timely
generic entry when exclusivities and patents have lapsed on branded drugs and
making sure their second and third to market innovation in some of these novel
indications.
Scott
Gottlieb: We've been
focused on trying to bring more product competition to the market with the hope
that if there's more products available within categories, the payment system
is either going to use that to create price competition or hopefully adapt to
figure out how to use that to create price competition in places where there's
a lack of price competition based on product variety like in Medicare Part B,
for example.
Scott
Gottlieb: That's where
we've been focused. I think one of the places you're going to see us focusing
more going forward aside from high-value generic opportunities is second and
third to market innovation in some of these highly novel classes. We now have
data that we will put out soon that shows that the time in which it takes to
get second to market innovation as some of these unmet medical needs, these
novel orphan categories and third to market innovation is taking much, much
longer. In many cases, we're seeing product categories remain monopolies in
perpetuity.
Scott
Gottlieb: I think that
there is a sense in the product development community. I've been on the other
side of this, on the venture side although I'm a little dated right now, having
been out of it for a few years, but I think there is a sense that if you're
going to be if you think you'll be third to market, you pull out. We're seeing
less competition in these categories.
Scott
Gottlieb: To the extent
that innovators are having monopolies for longer periods of time or in
perpetuity, that's not just creating an environment where prices stay higher
longer but it's also foreclosing the opportunity for therapeutic variety within
these categories. We know that therapeutic variety is important from a clinical
standpoint. Patients sometimes have a differential response to drugs, even if
they're largely similar molecules.
Tanisha
Carino: Right. I know we're
almost out of time. I'm going to give you last question. Everybody who's been
on the stage has been able to talk about what the future of health is. For you,
what do you think is the most exciting thing that we have to look forward to in
terms of health?
Scott Gottlieb: I'll tell you, the thing that
I'm focused on right now the most is what we're doing on tobacco, quite
frankly. I think that we have and I know it's not necessarily the answer that
ties to some of these technology issues but I think that we have an opportunity
when I came into FDA, we saw that smoking rates were declining in this country.
I think if we get our policies right over a short period of time, we have the
chance to dramatically accelerate the decline in smoking in this country.
That's going to have a more palpable public health impact than perhaps any
single product introduction that I can contemplate in any reasonable period of
time.
Scott
Gottlieb: It's going to
require us, thank you, to more rapidly migrate adults off of combustible tobacco
products onto products that have reduced risk. We have to embrace the concept
of modified risk nicotine delivery products including e-cigarettes. It's also
going to require us to make sure that those e-cigarettes, if we make them
available for currently addicted adult smokers, don't become tools for
addicting a generation of youth on nicotine. That's what we're seeing right
now.
Tanisha
Carino: Got a lot of fans in
the room for that.
Scott
Gottlieb: We will have
much more to say about this in about four weeks.
Tanisha
Carino: Thank you for
spending your day with us, Scott, I know it's been a busy day. Please join me
in thanking the commissioner.
Scott
Gottlieb: Thanks a lot.
Thank you.
Conrad
Kiechel: Thank you,
everybody and good afternoon. Thank you also for your insights and your time to
Scott Gottlieb.
Conrad
Kiechel: In just a few
minutes, we're going to be serving the rest of lunch and our main course, which
is our chairman Mike Milken's presentation 25 Years: The Quest to Create More
Healthy, Lengthy, and Meaningful Lives, but before the meal we wanted to take a
moment to give thanks.
Conrad
Kiechel: First, thank you
for joining us here at the Milken Institute Future of Health Summit. We've had
great feedback in the last couple of days from many of you. We hope that the
insights and the inspiration connections you've garnered here will help inform
and inspire the work that you continue to do.
Conrad
Kiechel: The Future of
Health Summit would not have been possible without the work and commitment of many,
many people, some of whom are in this room. In addition to our partners at the
Baker Group, Vision Matrix and our host here at the Ritz-Carlton, please join
me in thanking our dedicated wonderful staff at the Milken Institute. Thank
you, staff. Thank you. Thank you for Mr. Milken.
Conrad
Kiechel: There are also some
very important people, some of whom are in this room, some of whom are not.
Those are our sponsors who make the work of the Milken Institute possible not
just for the summit but year-round. We're having a special reel to thank them
as well. Thank you and enjoy your lunch. Bye.
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