The Wheels on the Bus go 'Round and 'Round

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  • 12/09/2011
Solid reporting from Matt Herper over at

Did The Obama Administration Throw The FDA Under The Bus?

Susan Wood quit her job as an assistant commissioner for woman’s health at the Food and Drug Administration in 2005 because she thought political, not scientific, forces were delaying efforts to make the Plan B emergency contraceptive available without a prescription. Four years later, she rejoiced when she was present to watch President Barack Obama sign a statement that said decisions in his administration would be based on science, not politics.

Now she says she is beyond disappointed. Obama’s Secretary of Health and Human Services, a member of his cabinet, Wednesday made a new decision to prevent a further expansion of Plan B’s over-the-counter use, this time to adolescents, overruling not only FDA staffers but also the drug agency’s commissioner, Margaret Hamburg. Although the HHS secretary, Kathleen Sebelius, was within her legal authority under the 1938 law that created the FDA, this is the first time a presidential administration has ever publicly overruled the FDA in this manner.

“This is contrary to the scientific integrity memo signed by Obama,” Wood says. “It’s contrary to the whole principal of making decisions based on science and evidence.”

Wood says the decision sets “a terrible precedent for the whole breadth and depth of the FDA” and that the “medical and scientific expertise to make such decisions and recommendations truly resides in the FDA,” not elsewhere in Sebelius’ department. The only silver lining, Wood says, is that by publicly standing up to Sebelius with a letter of protest posted on the FDA’s web site, Hamburg may have prevented the decision from demoralizing rank-and-file FDA staffers.

President Obama asserted yesterday that he “did not get involved in he process” but backed Sebelius’ decision. Whatever the merits of the plan B decision, using Sebelius’ power in this way may tarnish what has been one of the Obama administration’s great, pro-business achievements: Hamburg’s successful transformation of an embattled FDA, scarred and damaged by the controversies over big pharmaceutical industry scandals like Vioxx and Avandia, into an agency that is approving new medicines and a near-record clip and clearly and efficiently deals with new controversies as they crop up.

The question is whether this decision is a one-off, or a change in the way medicines are regulated. Could future negotiations with drug companies be weakened by the fear that the FDA commissioner would be overruled? And even if Sebelius is always going to back up Hamburg on every other regulatory decision, what about future administrations?

David A. Kessler, who headed the FDA between 1990 and 1997, praises the Sebelius and Hamburg for being transparent by airing their disagreement in public. And he says that for many decisions like Plan B, even if they are based on science, reasonable people can disagree. “There’s no scientific textbook where you can look up the answer,” he says. “You can respect people coming out on different sides.” His worry is not about whether 11-year-olds should need a prescription for Plan B, but about what happens in the future if decisions traditionally made by FDA scientists become cabinet-level political issues.

“My concern is just that it’s lousy precedent,” says Kessler. “The last thing you’d want is to have this be seen as precedent so any new drug applicant sees the decision-maker as the secretary. That’s not the way it’s ever worked or should work.”

Others put their opinions even more bluntly. “The decision on Plan B by the secretary represents an unprecedented level of interference in the FDA process and puts the country on a slippery slope toward politicization of science,” says Steven Nissen, a physician who has been critical of the FDA in the past. “Future political leaders may choose to overrule the FDA on much more critical decisions.” Nissen said he was not speaking for his employer, the Cleveland Clinic, where he is chairman of cardiology.

Peter Pitts, a former FDA associate commissioner who now works at the Center for Medicine in the Public Interest, a right-leaning think tank that receives drug industry funding, echoed those views, calling the decision “outrageous.” Pitts says: “It opens up the hornet’s nest of companies lobbying HHS, of members of Congress lobbying HHS. It’s a Pandora’s box of a decision.”

Not everyone agrees Sebelius’ move will have such far-reaching effects. For one thing, political pressures have in the past been brought more privately on the FDA – it’s not clear that the public argument between Hamburg and Sebelius really changes things. Ramsey Baghdadi, a founder at Prevision Policy, a consultancy, and an editor at the RPM Report, says Plan B is “a unique situation that demonstrates how FDA has to grapple with the intersection of science, politics and policy all at once.”

Baghdadi says it is possible that the Plan B controversy could lead Hamburg to exit the FDA. He calls this “highly speculative,” but notes that Hamburg was appointed when former Senator Tom Daschle was expected to head HHS; she was not a Sebelius pick.

Plan B is thought to generate only about $200 million for its maker, the generic drug giant Teva, and the new regulation was seen as only a minor issue in terms of public health. But the emergency contraceptive, which reduces the chance of pregnancy after unprotected sex by half, is one of a series of issues that have made the FDA into a political football over the past decade, often at times when the agency was without leadership.

The controversy over Merck’s painkiller Vioxx, which increased patients’ risk of heart attacks, resulted in congressional hearings that, in turn, resulted in tougher new drug approvals and voluntary industry limits on drug promotion. Safety issues and badly conducted clinical trials with the antibiotic Ketek helped make antibiotic approvals so tough that drug companies seemed to abandon the field en masse. The backlash over the diabetes drug Avandia led to new hurdles for heart safety for medicines to lower blood sugar. The drama has hurt the drug industry.

Hamburg’s leadership has more or less turned this around. She handled the controversial decision over whether to withdraw Roche’s approval to market Avastin for breast cancer with aplomb, backing her scientists that the data did not support the drug’s use. Although bad for Roche, many in the drug industry saw this as a positive step, because there were fears that not revoking Avastin’s approval would have made it harder for experimental drugs to be approved in the future.

In the fiscal year that ended Sept. 30, the FDA approved 35 new medicines, the second-highest count this decade. New initiatives appear to be making it easier for companies to get clear guidance as to what they need to get new drugs approved. For the first team in years, the FDA seems anything but rudderless – a change that is great for the pharmaceutical industry, which depends on strong, clear, and consistent regulation. The Plan B decision may have set back that turnaround, and, if saner heads don’t prevail in rebuilding the wall around the FDA, it could do long-term damage to medicine in the years to come.


Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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