White House vs. FDA: Plan B decision still reverberates

In the New York Times last week, Gardiner Harris reported on tensions between FDA and the White House over FDA decisions that White House officials fear will be politically problematic for President Obama. Harris reminds readers that "The Bush administration repeatedly stopped the agency from issuing rules to prevent contamination of eggs, produce and other foods ... Much of the agency's staff assumed that the Obama administration would restore the agency's independence."

This assumption of the Obama administration restoring agency independence wasn't unfounded -- less than two months after taking office, President Obama issued a presidential memorandum on scientific integrity and pledged at the signing ceremony to let federal-agency scientists do their jobs "and [listen] to what they tell us, even when it's inconvenient -- especially when it's inconvenient."

My colleague Susan Wood, who had resigned her FDA position as assistant commissioner for women's health in 2005 out of frustration over the Bush administration's handling of the request to approve over-the-counter sale of emergency contraceptive Plan B, happily attended that signing ceremony for the scientific integrity memorandum. But, she wrote in an a Washington Post op-ed this past December, "That promise was betrayed this past week when Health and Human Services Secretary Kathleen Sebelius overruled the FDA commissioner -- and all of the physicians and scientists at the FDA -- in blocking the agency's decision to allow an emergency contraceptive to be available over the counter for all who need it."

(Some background: The Bush administration FDA allowed women 18 and older to purchase Plan B without a prescription, and that age was reduced to 17 in 2009 following and order by US District Court Judge Edward Korman to do so. Plan B One-Step is the new single-dose version of Plan B, which consisted of the same dosage split into two pills, and in early 2011 its manufacturer filed an application with FDA for this version of the emergency contraceptive to be sold over the counter. In December 2011, FDA Commissioner Margaret Hamburg stated that "there is adequate and reasonable, well-supported, and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of child-bearing potential" -- but that Secretary Sebelius was invoking her authority over FDA and requiring that the approval be denied.)

In his article on the tensions between the White House and FDA, Harris quotes Susan Wood describing herself as an optimist and expressing hope that President Obama will "find a way to stand by his promise" to uphold scientific integrity and allow agencies to make their decisions based on science rather than political considerations. Now, in a piece in the Daily Beast, Wood reiterates her optimism but also to emphasizes that regardless of what President Obama does going forward, Secretary Sebelius's Plan B decision will have severe and lasting consequences:

On its surface, the secretary's action was a small thing. After all, invoking concerns about sexually active preteens is enough to garner the support of most parents, no matter what. But when Sebelius decided to block the FDA's recommendation, and when she asserted her own interpretation of medical and scientific data, she set a new and potentially dangerous precedent.

While the HHS secretary does have final legal authority to make decisions for the FDA, by law these decisions must be made based on very specific and limited criteria. Political considerations are not one of them. The FDA makes recommendations based on scientific evidence to ensure that the products it approves are safe and effective. Approving or blocking medications based on political or other grounds is a slippery slope.

Imagine a future secretary appointed by a president who objects to, say, embryonic stem-cell research. Pointing to the Plan B decision, this new secretary could assert that he or she doesn't believe the data showing effectiveness of a stem-cell-based cancer therapy and so could deny approval. Or maybe a major political contributor wants a new drug or device approved (or blocked)? The secretary--a senior political appointee, after all--could identify a "scientific" rationale to overrule the decision by the professional medical and scientific staff at the FDA.

There is a good reason why earlier secretaries have not publicly or formally overruled "controversial" FDA product-approval decisions: it doesn't benefit the public's health, and all of us are at risk if we cannot trust the FDA's decisions.

There are real options for the HHS and FDA to revisit the Plan B decision and to ensure that it does not set a very risky precedent. It all starts with giving independence back to the scientists and physicians at the FDA--who, it should be noted, have recommended full approval for Plan B over the counter for nearly 10 years.

Read the whole thing here.

Gardiner Harris's article also brings up the lasting impact to FDA's reputation:

And some analysts worry that the administration's increased engagement could erode the F.D.A.'s reputation for regulatory thoroughness and integrity.

"In a globalizing world, where trust is a huge part of what American manufacturers have to sell, the politicization of the F.D.A. could hurt not only consumer protection but industry profits as well," said Daniel Carpenter, an F.D.A. historian at Harvard University. "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 F.D.A. recommendations anymore.' "

The White House may think that delaying or altering FDA's science-based rules and decisions will help President Obama win re-election. Even if Obama were to somehow switch course after the election and give FDA the true independence so many of its staff have been missing, though, the damage to the agency's credibility and influence will already have been done -- and future HHS Secretaries will have a much freer rain to further harm the agency and public health.