WASHINGTON Oct 10 The retirement of Dr. Janet
Woodcock as head of the Food and Drug Administration's
pharmaceutical division is at least a year away, but already the
industry she regulates is worrying about who will replace her.
Over the past 20 years Woodcock, who is 65, has reshaped the
drug approval process, relaxing the criteria needed for certain
drugs to reach the market - especially those that represent
scientific breakthroughs. Last year, the agency approved 39 new
drugs, the most since 1996.
That is good news for drug companies who depend on product
approvals to fuel profit growth, and some fear that once
Woodcock leaves the pace of drug approvals will slow. She also
appears to have done little to develop a bench of potential
successors - a challenge Woodcock acknowledges.
"No-one is seeing that luminous, next-generation
leadership," said Dr. Robert Meyer, a former top medical
reviewer at the FDA who subsequently joined drug maker Merck &
Co as a vice president and in March took an academic
position at the University of Virginia.
According to interviews with some two dozen people inside
and outside the agency who have worked with her, Woodcock is a
force of nature. She moves from meeting to meeting - sometimes
as many as 16 a day - with crisp efficiency, dealing one minute
with a complex cancer drug and the next with an angry
lawmaker. The learning curve for her successor will be steep.
"The thought of bringing someone in and expecting them to
take over from Janet Woodcock any time soon is the ultimate
absurdity," said one former senior FDA official who asked not to
be identified because he now works for a company that deals with
Woodcock's boss, FDA Commissioner Margaret Hamburg,
acknowledges the difficulty.
"It's very hard to parachute into these jobs," she said in
an interview, noting that a wide variety of skills - management,
scientific and regulatory - are needed for the role.
Woodcock's influence at the FDA, and by extension the global
pharmaceutical industry which takes its lead from the United
States, is hard to overstate. While the commissioner may be the
agency's public face, Woodcock is its institutional memory and
drives pharmaceutical policy.
The office she runs, the Center for Drug Evaluation and
Research, is by far the agency's biggest, with a budget of more
than $1 billion and a staff of 3,450. Her actions are
scrutinized by companies, regulators, physicians, patients and
investors around the world.
Yet she is struggling to come up with a deep pool of
"We get people in, they almost take the ring, they're at the
altar, and then they realize they have to divest everything,"
Woodcock said in an interview. Employees must eschew stocks and
other investments in FDA-regulated companies because they are
privy to market moving information.
In February, Woodcock hired Dr. Richard Moscicki, former
head of clinical development at the biotechnology company
Genzyme Corp as one of her top deputies. Moscicki said he would
"welcome the chance, as daunting as it is to watch Janet," to
take over if the opportunity arose.
But installing any former pharmaceutical executive would
almost certainly prompt criticism from drug safety watchdogs who
already claim the FDA is too cozy with the drug industry - a
charge Woodcock has heard many times and rejects.
"If industry wasn't around, patients would be in deep
trouble, many of them," she said.
Woodcock, who trained as a rheumatologist, is a career civil
servant. Petite, with short brown hair and eyebrows that rise in
quizzical fashion, she does not tolerate fools gladly; and she
can be weak at delegating, former colleagues say.
That may have limited the number of people able to advance
into more senior roles, though possible candidates do exist, the
former colleagues said. For a list of potential successors,
Woodcock says her goal is to "put the right people in
charge," not micromanage, but she says finding those people is
"I know some of my senior office directors have tried to
recruit in and they have gotten repeated turndowns from people
who would be fabulous," she said. "It's mainly the money."
Government salaries can be at least 10 times lower than the
$1 million plus packages on offer at drug companies.
Woodcock said she has begun giving certain people within the
FDA more responsibility but some say it is has been hard for
talent to rise easily to the top. For example, a 2006 report by
the Institute of Medicine described a work environment at the
Center for Drug Evaluation and Research "that is not
sufficiently supportive of staff."
Even Woodcock's most ardent admirers concede she can be
"One thing every chief executive has to worry about is
whether they scare the hell out of people," said Dr. Robert
Temple, one of Woodcock's closest colleagues. She tries not to
be frightening, he added, but is by nature "formidable."
DRUG DEVELOPMENT PRIORITY
Woodcock has used her influence in part to bend the agency's
agenda to her own. She believes more new drugs mean greater
choice and better patient outcomes, and has made drug
development a central part of the FDA's mission in a way that
was not historically the case and that not everyone agrees with.
Some colleagues felt the agency should focus principally on
drug safety and law enforcement.
"People who had been there a long time had a more old-school
view, that our job when we got drug applications was just to
look for safety and efficacy, and have that high bar," said
Meyer. "I never heard Janet articulate anything about lowering
the bar, but there was a bit of a philosophical shift and I
think she was ahead of the curve on that."
Woodcock insists that the agency has not relaxed its safety
standards, but there is some evidence to suggest it is more
reluctant than other countries to withdraw or restrict
potentially dangerous products.
A study published last year in the journal Innovations in
Pharmacy found that of roughly 150 drugs that the United Nations
lists as banned around the globe, 17 percent are available in
the United States. Only 9 percent of drugs banned by the United
States are available internationally.
"It shows that the U.S. may no longer be leader in
observing, reporting and removing dangerous drugs from the
market," Albert Wertheimer, the study's author, concluded.
Wertheimer is a professor in the school of pharmacy at Temple
University in Philadelphia.
Woodcock declined to comment on the report.
The FDA's focus on new drug development has also angered
generic drug companies, who face significant delays getting
their products reviewed. The office that handles generic drugs
is understaffed and overwhelmed by the number of new
applications, which have risen from a couple of hundred a year
to more than 1,000.
"To me, a good manager would divert some resources to an
office that is struggling," a former senior official in the
division said. "The fact that 80 percent of drugs prescribed in
the United States are generic doesn't seem important to the
Woodcock says the generic drug office has not received the
same kind of funding as the office in charge of novel drugs
because until recently the FDA did not receive fees from generic
drug makers, as it does from branded companies, to review
applications within a set time period. She expects that to
As Woodcock moves towards the end of her career, she has one
more major initiative up her sleeve: a plan to help the drug
industry improve quality control by introducing, among other
things, techniques to identify and remove the cause of defects
during the manufacturing process.
"People are moving now to continuous manufacturing and
really much more high tech modern ways and it doesn't fit the
way good manufacturing practice has been thought about over the
years," Woodcock said. "We have to forcibly make sure we allow
the better to come about."
(Editing by Edward Tobin, Martin Howell and Grant McCool)