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