Political meddling in the FDA’s scientific decision-making, which began under President Clinton, seems to have cost the agency dearly in public opinion, judging by a recent poll.
Sixteen years ago, when there were no White House-FDA interactions that we know of, the agency’s then acting commissioner publicly boasted about a poll showing the FDA as the US’ most admired regulatory agency.
Now comes a Wall Street Journal Online/Harris Interactive poll of 2,371 adults showing that 80% were very or somewhat concerned about the agency’s ability to make independent decisions on safe and effective medicines. And 82% said the agency’s decisions are influenced to some extent or a great extent by politics.
The survey didn’t mention the current fuss over the FDA’s stalling on the Plan B emergency contraceptive, but the strong public perception of political interference doubtless let 64% of respondents tell the pollsters that FDA does a poor job of deciding which drugs can be marketed OTC.
Too late to affect the poll, former commissioner Lester Crawford vigorously rebuffed public suspicions about Plan B when he swore in a federal court deposition unveiled on June 12 that he received no political or ideological direction in deciding to further delay approval pending new rulemaking on whether it can be marketed both OTC and by prescription only for those under 17.
Even if Crawford is believed, the damage may already be done. Fresh controversy in a different lawsuit is brewing over revelations that in its closing months the Clinton administration caused the FDA to rush the approval of the abortion pill RU-486 (Mifeprex) ahead of incoming Republicans’ threats to block it.
This genie will be hard to put back in the bottle. Political intrusion on FDA science is a trend, it must end.
Dickinson is editor of Dickinson’s FDA Webview (fdaweb.com)
From the July 01, 2006 Issue of MM+M - Medical Marketing and Media
