01.15.21

Senator Murray Urges Health Department to Reverse Sudden Changes That Undermine Food and Drug Administration’s Independence

Reporting reveals HHS has rushed to enact major policy changes at the FDA without input from the agency

 

Murray: “These efforts jeopardize the public health mission, priorities, and integrity of FDA and show blatant disregard for the expertise of FDA career staff.”

 

(Washington, D.C.) – Yesterday, Senator Patty Murray (D-WA), ranking member of the Senate Health, Education, Labor, and Pensions (HELP) Committee, reached out to Secretary of the Department of Health and Human Services (HHS), Alex Azar, to express her strong opposition to sudden steps announced by the Department in the final days of the Trump Administration that undermine the independence of, and public confidence in, the Food and Drug Administration (FDA).

 

“I am alarmed by recent actions of the Department of Health and Human Services (HHS) to impose major policy changes on the Food and Drug Administration (FDA) — and by reports that HHS is seeking to place additional, sweeping restrictions on FDA’s regulatory authority in the coming days. These efforts jeopardize the public health mission, priorities, and integrity of FDA and show blatant disregard for the expertise of FDA career staff,” wrote Senator Murray.

 

The letter goes on to specifically call out the Trump Administration’s failure to communicate with FDA experts or consider their input regarding changes that will impact the agency’s work to ensure the safety and effectiveness of medical devices.

 

The letter is the latest in Senator Murray’s efforts to push back on moves by the Trump Administration that undermine the work of public health officials. She has also written to the Administration opposing changes that undermine the FDA’s ability to regulate laboratory-developed tests and about other interference in the work at FDA and the Centers for Disease Control and Prevention, introduced legislation to stop political interference in the nation’s COVID-19 response, and grilled public health officials about the Administration’s interference at a HELP Committee hearing.

 

“Now more than ever, the American people must have confidence that FDA policy is firmly rooted in science and supported by FDA experts. For these reasons, I urge you to immediately rescind all policy changes imposed on FDA and defer to FDA expertise in future FDA policy,” Senator Murray concluded.

 

 

Full text of the letter is below and a PDF is available HERE.

 

                                                            January 14, 2021

The Honorable Alex M. Azar

Secretary

U.S. Department of Health and Human Services

200 Independence Avenue, SW

Washington, D.C. 20201

 

Dear Secretary Azar,

 

I am alarmed by recent actions of the Department of Health and Human Services (HHS) to impose major policy changes on the Food and Drug Administration (FDA) — and by reports that HHS is seeking to place additional, sweeping restrictions on FDA’s regulatory authority in the coming days.[1] These efforts jeopardize the public health mission, priorities, and integrity of FDA and show blatant disregard for the expertise of FDA career staff.

 

Over the past six months, HHS has issued a series of FDA policy pronouncements without input from FDA officials and, in a number of cases, over their objections.[2] Just this week, HHS proposed to exempt numerous medical devices from FDA premarket notification requirements without consulting FDA experts.[3] These actions are unacceptable. It is critical that FDA career staff are given the latitude to formulate agency regulations and policy based on the best available scientific data.

 

For the past year, FDA career staff have been working tirelessly in the fight against COVID-19. HHS’s unilateral actions to dictate FDA policy undermine these efforts and FDA’s reputation as a premier science-based agency. Now more than ever, the American people must have confidence that FDA policy is firmly rooted in science and supported by FDA experts. For these reasons, I urge you to immediately rescind all policy changes imposed on FDA and defer to FDA expertise in future FDA policy.

 

Sincerely,

 

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[1] https://www.politico.com/news/2021/01/12/fda-independence-hhs-458515

 

[2] See Letter to Secretary Azar from Senator Patty Murray on HHS’ decision to allow the marketing of laboratory-developed tests without FDA review (Aug. 26, 2020). See also https://www.politico.com/news/2020/09/15/hhs-alex-azar-overrode-fda-testing-rules-415400; https://www.nytimes.com/2020/09/19/health/azar-hhs-fda.html; https://www.biocentury.com/article/632041/another-u-turn-for-covid-19-testing-regulation-as-hhs-requires-fda-to-re-prioritize-ldt-review

 

[3] https://www.hhs.gov/sites/default/files/drug-review-time-transparency.pdf