Plan B: When politics and science intersect at the FDA

Healthcare represents one-sixth of the US economy and touches the lives of all Americans.

Healthcare represents one-sixth of the US economy and touches the lives of all Americans. Given the industry's broad scope, it's hardly surprising that the worlds of healthcare and politics sometimes collide.

While this is expected in the creation of health policy, most notably played out in the debates over contraceptive coverage in the Affordable Care Act, we are less used to seeing the specter of “politics” cast its shadow over the US Food & Drug Administration.

With a “church and state” separation, government health agencies are supposed to make decisions based on science, not politics. But in a stunning development at the end of last year, US Department of Health & Human Services Secretary Kathleen Sebelius overturned FDA approval of the emergency contraceptive Plan B to be sold without age restrictions. Currently, the contraceptive, sold over the counter, is only available to women age 17 and older.

It is highly unusual for HHS to interfere with a decision from the FDA. Sebelius cited concerns about product safety in younger girls, though the FDA has data that supports safety claims for younger users. The decision was greeted with howls of protest from women's health groups who were dubious about the safety issue and believed the decision was politically driven. Sen. Patty Murray (D-WA) said she wanted to see scientific evidence of Plan B being unsafe for girls of a younger age.

President Barack Obama also waded into the fray, saying it was “common sense” to avoid allowing 10- and 11-year-old girls to purchase Plan B “alongside bubble gum and batteries.” Conservative family values groups lauded the decision, while liberals stewed.

The controversy did not end there. On January 30, proponents of Plan B made their case before an FDA Pediatric Advisory Committee, though it is unlikely HHS will reverse its decision.

There are legitimate arguments for not making Plan B available to young girls. Health risks and psychological considerations should certainly be evaluated, but this kind of decision should be free of political calculus. 

The FDA is held in high regard because most Americans believe in its mission to safeguard public health and to use the rigor of science to do so. When it comes to healthcare decisions, we want government agencies to be politically agnostic.

It is hardly surprising that a socially charged issue like Plan B would become entangled in election-year politics. The outrage had less to do with the merits of allowing younger girls access to the product than with overriding a decision based on scientific recommendations.

This imbroglio is but another reminder of the complexities of healthcare issues that have moral and political dimensions as well as medical and scientific. So many of the issues communicators touch have moral and political dimensions as well as medical and scientific.

Nancy Hicks is SVP in Ketchum's Washington office. She also serves as associate director of the agency's North American healthcare practice and is co-author of Healthcare Industry Communications: New Media, New Methods, New Message, published in late 2011.

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