Should The FDA Be An Independent Agency?

Should The FDA Be An Independent Agency?

January 3rd, 2012 // 1:13 pm @

The outrage and hand-wringing continues over the unprecedented decision last week by US Human & Health Services Secretary Kathleen Sebelius to overrule the FDA and thwart a move to ease access to the Plan B pill, which is also known as the morning after pill. The move has generated intense debate that the White House politicized the FDA in favor of promoting sound science.

Those who supported approval of the pill saw the move as not only dangerous, but ironic, given that President Barack Obama had made a point, earlier in his administration, of insisting that decision making must favor science, not politics. Now, though, he is being widely criticized, by some, for pandering to conservatives as he campaigns for re-election. The FDA had favored making it possible for girls who are 17 and younger to get the pill without a prescription.

Yesterday, 14 US Senators wrote Sebelius for an explanation. “We ask that you share with us your specific rationale and the scientific data you relied on for the decision to overrule the FDA recommendation. On behalf of the millions of women we represent, we want to be assured that this and future decisions affecting women’s health will be based on medical and scientific evidence” (see here).

To opponents, Plan B is problematic because the pill prevents a fertilized egg from implanting in the womb, which equate this with abortion. But supporters of greater access argue that nearly half of all pregnancies are unintended, and that preventing teenage girls from gaining easier access denies them a safe and effective way to prevent unintended pregnancies (see more here).

Sebelius had the legal right to overrule the agency, although the FDA earlier this week offered a tortured explanation for complying with her orders. The agency explained that Teva Pharmaceuticals erred by submitting data and usage studies for Plan B One-Step, which contains twice the active ingredient of Plan B and has a different dosing regimen. This was cited as legal grounds for rejecting easier access (read here).

So where does this leave the FDA? Has the Obama administration embarked on the proverbial slippery slope in which FDA decisions may be influenced by politics or, arguably, other interests? And even if such influence does not occur again, is the agency reputation tarnished because future decisions will be subject to second-guessing and worse?

“The possibilities opened by this decision are frightening. A radical pro-business secretary could now, in principle, bypass the clinical trial system and the FDA approval process and decide to approve a drug. A different secretary, one distrustful of the pharmaceutical industry, could stop a drug despite strong scientific support behind it,” writes Daniel Carpenter, the Allie S. Freed professor of government at Harvard University and the author of “Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA” in an op-ed in The New York Times (see this).

His solution? Make the FDA an independent agency. “Americans have already done this, through the Federal Reserve, to protect our money supply from political meddling; it’s time to do it for drugs,” he argues. Like the Fed, an FDA commish should get a six-year term. And while he acknowledges White House interference could still occur, a president could not hide behind his cabinet secretaries when tussling with an independent agency.

Of course, independence is in the eye of the beholder. The FDA continues to receive industry funding in the form of user fees that are used to support the drug-review process, which some agency critics argue say leaves the agency open to influence. Nonetheless, establishing an independent would not give the White House automatic veto power over such decisions. But what do you think? Is this a good idea?

Source: Pharmalot


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