Politics, FDA, and the Plan B DecisionDecember 13, 2011
By James R. Phelps –
Many seasoned FDA watchers are surprised by the kerfuffle raised when HHS overturned FDA’s plan to allow Plan B emergency contraception available over the counter (see here and here). This is first time HHS has publicly put its thumb on the scale, and critics cite President Obama’s statement that FDA’s decisions would be based on science, and not politics. Critics say they fear the precedent means that politics will now have a role in FDA’s processes. The sober publication, Forbes, headlined its coverage of the Plan B matter this way: “Did the Obama Administration throw FDA under the Bus?” and quoted numerous medical and other personnel concerned about political influences.
The critics of Secretary Sebelius’ action may not like the result, but they are overwrought insofar as they worry about politics entering FDA’s processes. The fact is, politics has always played a role in FDA’s work. The Forbes article quotes Ramsey Baghdadi, an editor of the RPM Report, who correctly sees FDA’s Plan B decision at the “intersection of science, politics, and policy.”
FDA’s leaders emphasize the role of science in the agency’s decisions. Scientific methodology yields data, but it does not tell us how that information should be used. Determining how and whether to use the information is a matter of judgment, and the human interactions to make and implement such a judgment inevitably will involve politics.
Politics is the advocacy of one’s interests. “Interests” is a broad term; for example, interests can be commercial and they can be ideological. People inside FDA will push for their interests as regulators. People outside FDA – in private enterprises and other government organizations, such as HHS – will press to have their interests taken into account.
Politics, from external sources and from within the agency itself, are inevitably given play in FDA’s decisions. How much influence they will have will depend on many variables; in the Plan B situation, the important variable was that the HHS secretary had statutory authority to do what she did. Some will cite happy consequences of political actions within and with FDA. Others will cite examples of what they see as untoward consequences. But no one should be surprised to see that FDA is subject to political influences.
- FDA Plan B Rx-to-OTC Switch Citizen Petition Denial (FDA Docket No. 2001P-0075; Dec. 12, 2011)
- Press Release – Senators Call on Sec. Sebelius to Explain the Science Behind Plan B Decision