Mental Health Groups Protest FDA Actions against PGX (Politico Subscription)

2019/09/26

https://www.politico.com/newsletters/politico-pulse/2019/09/26/how-impeachment-push-is-shaking-up-health-agenda-759972

FIRST IN PULSE: Mental health groups pan FDA's genetic testing stance. Advocates urged HHS Secretary Alex Azar and acting FDA Commissioner Ned Sharpless to reverse FDA's position on using genetic tests to inform treatment for depression and other mental health conditions, POLITICO's Brianna Ehley reports.

The FDA last year warned that genetic tests couldn't predict patient responses to antidepressant medications and moved to crack down on developers making those claims.

But advocacy groups — including the National Council for Behavioral Health, Mental Health America, the National Alliance on Mental Illness, and the Depression and Bipolar Awareness Alliance — argued in their letter to Azar and Sharpless that FDA's actions could "inflict greater harm on patients and impede innovation" given the potential of genetic information and some early, positive results.

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Mental health letter here.

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For links to September 2019 status of Senate health funding:

https://www.thenationalcouncil.org/capitol-connector/2019/09/senate-health-appropriations-language-released/

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For an open access Politico article on September 12, 2019, on the Executive Branch's 2020 health agenda, here.