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.
