FDA battling White House over politicization of regulation

After operating on a very short leash during the Bush administration, many FDA staffers thought that a new era of independence from political forces at the White House was upon them when President Barack Obama took office.

They were flat wrong, and they're ticked off.

Politics has peppered Obama loyalists' spats with FDA officials over counting calories in movie theater popcorn and how to regulate birth control pills, an article in The New York Times suggests. For the pharmaceutical industry, the strained relationship between the FDA and the Obama camp has led to some curveballs, and thought leaders are raising concerns about wounding industry profits.

Take last year's FDA nod for KV Pharmaceutical's ($KV.A) drug 17P, the first drug of its kind approved for preventing premature birth after decades of use. The government was expected to take action against versions of the drug prepared by pharmacists that hadn't been approved, and KV went to market with a price tag for 17P that dwarfed the pharmacist preparations. Yet fearing the cost implications of not stymieing use of the cheaper options in favor of the pricey one, the White House intervened to allow continued access to the pharmacist version, The Times reported. Sorry, KV.

Politics, of course, was widely suggested to be Health and Human Services boss Kathleen Sebelius' motive for trumping the FDA's decision on the Plan B morning-after pill, limiting access of the drug to certain teens. FDA officials also butted heads with White House deputy chief of staff Nancy-Ann DeParle over the agency pushing for movie theaters and others to post calorie counts for foods such as butter-laden popcorn, the Times reported. That spat came amid the debate over Obama's healthcare reform bill, and there were concerns that Republicans and conservative media would use such cases of increased industry regulation to torpedo the legislation.

What does this mean for drugmakers? Well, political meddling could threaten the global standing of the FDA as a model regulator whose decisions carry weight around the world.

"In a globalizing world, where trust is a huge part of what American manufacturers have to sell, the politicization of the FDA could hurt not only consumer protection but industry profits as well," Daniel Carpenter, an FDA historian at Harvard University, told the Times. "If this trend continues, one could easily see major government purchasing programs in Europe, India, China and elsewhere saying, 'We're not going to follow FDA recommendations anymore.'"

- get more in the Times article

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