Historical materials on payers and accelerated approvals

 

https://pink.pharmaintelligence.informa.com/PS121818/Gottlieb-Defends-Accelerated-Approval-Scorns-Access-Limits-By-Payors

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https://pink.pharmaintelligence.informa.com/PS122410/Gottlieb-If-Trials-Show-More-Certain-Benefit-Risk-Can-Be-Considered-LongTerm

Gottlieb: If Trials Show 'More Certain Benefit,' Risk Can Be Considered Long-Term

31 Jan 2018

ANALYSIS

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https://pink.pharmaintelligence.informa.com/PS122058/Progressive-Approval-Coming-US-FDA-Considers-Accelerated-Approval-Without-Surrogates

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https://www.theatlantic.com/health/archive/2021/07/americas-drug-approval-system-unsustainable/619422/

The FDA Is a Melting Iceberg

For decades, scientists have been crying out for action. Will they finally be heard?

By Benjamin Mazer

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https://washingtonmonthly.com/2021/07/10/the-fda-is-broken/

by Shannon Brownlee and Jeanne Lenzer

July 10, 2021

The FDA Is Broken

How the Food and Drug Administration messes up approval of new drugs including the new one, aducanumab, that supposedly helps Alzheimer’s disease patients.

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https://scholarlycommons.law.cwsl.edu/cgi/viewcontent.cgi?article=1329&context=fs

2019 Law Review Bohner Drug Pricing Unmet Need Conditional Approval 47pp.pdf

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https://www.fda.gov/news-events/speeches-fda-officials/remarks-national-comprehensive-cancer-network-policy-summit-06252018

SPEECH

Remarks to the National Comprehensive Cancer Network Policy Summit

JUNE 25, 2018

Remarks by Scott Gottlieb, M.D.

Commissioner of Food and Drugs

The National Comprehensive Cancer Network Policy Summit

Washington, DC

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https://www.biopharmadive.com/news/follow-up-studies-often-lacking-for-cancer-drugs-approved-early/555733/

Follow-up studies often lacking for cancer drugs approved early

Published May 29, 2019

Ned Pagliarulo's headshot

Ned Pagliarulo

Lead Editor

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https://friendsofcancerresearch.org/news/pink-sheet-breakthrough-therapy-lower-bar-evidence

Pink Sheet - Breakthrough Therapy: 'A Lower Bar Of Evidence'?

Ramsey Baghdadi | February 07, 2018

Executive Summary

MedPAC meeting elicits negative view of designation from one members and no one disagreed. Should US FDA reiterate what the special designation actually means?

It may be time for the US FDA to reiterate to the public the high standard for granting a “Breakthrough Therapy” designation to a promising therapy in development.

There has always

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https://www.congress.gov/115/chrg/CHRG-115shrg25027/CHRG-115shrg25027.htm

    FIRST SESSION

                                   ON

     EXAMINING THE NOMINATION OF SCOTT GOTTLIEB, M.D., TO SERVE AS 

                     COMMISSIONER OF FOOD AND DRUGS

                               __________

                             APRIL 5, 2017

                               __________

 Printed for the use of the Committee on Health, Education, Labor, and Pensions

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