When science and politics collide: Support for enhancing FDA independence

FDA

Earlier this year, twin papers authored by seven former Food and Drug Administration commissioners, published by Health Affairs and the Aspen Institute on the same day, suggested that the FDA should become an independent agency.

A new paper by Eli Y. Adashi, Rohit Rajan, and I. Glenn Cohen appears in Science this week and picks up where those papers left off. Adashi, Rajan, and Cohen write that the crucial mission of the FDA, which has been to make science-based decisions about drug and medical device safety since 1938, has recently been undermined and threatened by politically motivated interference from congressional legislators.

In some ways, the FDA has been vulnerable to politicization from both sides of the aisle since the mid-1960s, resulting in a slow but steady loss of independence. However, write Adashi, Rajan, and Cohen, there has been a recent uptick in political influence on the FDA's decisions, including the recent Plan B debacle. In the long run, the American people are at risk of losing the independent drug safety watchdog they rely on.

While the FDA will never be truly free from political pressure, Adashi, Rajan, and Cohen support the move for a more independent version of the agency, and also suggest some safeguards, which will allow the agency to stay true to its mission. "The hope is, that when values clash, an independent FDA will navigate the conflict with the nation's best interest in mind," they write. Their suggestions include: a six-year term for FDA commissioners, budgetary independence modelled on the Federal Communications Commission (another independent agency), and rule-making authority with selective oversight by the Office of Information and Regulatory Affairs and Office of Management and Budget.

"The fate and stature of the FDA rest in the hands of lawmakers who may be reluctant to alter the status quo for fear of losing leverage," write Adashi, Rajan, and Cohen. "Failure to codify in law the independence of the FDA now or in the near future must be viewed as an opportunity missed."

Unless FDA's is protected, and science allowed to reign supreme, the effectiveness of the FDA could fall by the wayside in favor of politically motivated compromise.


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More information: E.Y. Adashi at Brown University in Providence, RI el al., "When science and politics collide: Enhancing FDA," Science (2019). science.sciencemag.org/cgi/doi … 1126/science.aaw8093
Journal information: Science

Provided by Brown University
Citation: When science and politics collide: Support for enhancing FDA independence (2019, May 16) retrieved 14 October 2019 from https://phys.org/news/2019-05-science-politics-collide-fda-independence.html
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May 16, 2019
It always worries me when a group, agency or branch of government want to take power away from the people we choose to represent us.
It starts by vilifying our legally chosen representatives and always seems to end in appealing to the conspiracy theorist found to some degree in us all.

May 17, 2019
Why do they need an FDA? Americans, brainless about science, stuff themselves themselves with billions of $$$ of worthless or perhaps dangerous supplements each year which proves they don't care about FDA oversight.

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