Hush job at the FDA: deny,delay and deceive? Read all about it:
FDA Struggles to Find Balance Between
Caution and Speed in Approving Drugs
By ROCHELLE SHARPE
Staff Reporter of THE WALL STREET JOURNAL April 20, 1999
WASHINGTON -- When the Food and Drug Administration approves a
new drug, top agency official Murray Lumpkin sends a congratulatory
e-mail to his staff.
But FDA employees don't find much to cheer about these days. The
agency is caught in pincers between two intense political pressures:
demands from the industry and the political right to move faster and faster
in approving drugs, and rising insistence from consumer groups and the left
to show more caution.
"The FDA is walking a tightrope," says Ron Johnson, who until 1997
worked as the agency's Pacific regional director for enforcement. "No
matter what the FDA does, it's wrong by somebody's count." And the
disputes don't end when the drugs go to market.
Not only did some women's groups
bitterly complain last fall about the
FDA approving tamoxifen as a
preventative for breast cancer, but
Public Citizen, a Washington-based
advocacy group, helped lead a
charge to try to get a controversial
new diabetes drug, Rezulin,
withdrawn from the market.
Conservative groups worry that a
record five drug withdrawals in the
past two years will cause the FDA to
become overly cautious yet again,
impeding approval of new drugs.
The FDA, part of the Department of Health and Human Services, has
always had a tough job balancing its various missions. But the conflicting
demands and resulting whipsaw effect are fueling the worst turmoil in
years, say past and present employees. Meantime, after drug-review
streamlining was begun in 1993, the number of drugs approved more than
doubled to 53 in 1996 before dropping back to 30 in 1998.
Scientists face tighter deadlines for drug reviews and fewer resources. The
agency's budget, flat for six years, now is so lean that officials have even
discussed a temporary closure to make ends meet. Top FDA officials say
the problems aren't compromising safety. "People used to working without
time frames are having to adjust," but "we do not believe time frames are
too short to do a thorough job," says Janet Woodcock, director of the
FDA's Center for Drug Evaluation and Research.
Still, there is an almost constant exodus of experienced staffers among the
agency's 8,900 employees. The turnover problem is partially a result of
timing. It has been nearly 25 years since the FDA launched Operation
Hire, an initiative that expanded the agency by hundreds of people. As a
result, 70% of all managers will be eligible for retirement within the next
two years, says Mary Pendergast, who left last year after 20 years with the
agency.
But many scientists say they are jumping at the chance to take a buyout
now because of working conditions inside the agency. "I decided it was no
longer worth my time to take the psychological and verbal abuse from
members of Congress or their staff," says Curtis Scribner, deputy director
of the FDA's blood office until late 1997. "I wasn't having fun any more."
Ralph Harkins, who headed a major statistical division at the FDA for
more than a decade, says: "I just decided I wasn't getting the support I
needed. I took my retirement and ran." In Mr. Harkins's division, which
analyzes about 70% of all drugs approved by the agency, 12 of 22
statisticians have left since 1998. Most were working more than 12 hours
a day to try to keep up with the speedier approval deadlines. (The agency
cut its final review of new drugs to 15 months, from 30 months in 1993.)
In 1993, the agency began accepting millions of dollars each year from the
pharmaceutical industry to speed drug approvals, and some FDA scientists
worry that drug safety has been compromised. Elizabeth Barbehenn, who
worked on animal-drug studies in the agency's metabolic and
endocrine-products division, quit last year because of safety concerns. She
says she watched her superiors rush to begin one human clinical trial, even
though it was still unclear whether the drug's toxicity was reversible.
"I don't know how you tell people you're putting them at risk for
permanent damage," she says. Not only did she quit, she defected to one
of the FDA's harshest critics: Public Citizen. The FDA declines to
comment on the incident, but says the standards for informed consent in
clinical trials have become stricter in recent years.
Not all reviewers see the user fees -- and resulting new deadlines -- as all
bad. Carol Trapnell, who recently left the agency after 12 years, says the
fees improved efficiency. The FDA is filled with "compulsive people," she
says, questioning whether sometimes their "careful, meticulous work" was
"just overkill."
Yet she and other scientists believe that the fees have changed the agency's
culture, encouraging reviewers to find some way to approve a drug. Gino
Girardi, a former medical reviewer, calls the new dynamic "approval
creep," because drug applications were revisited over and over "until there
was approval for a single indication." If a reviewer wants to deny a drug
approval, Mr. Girardi says, he must be prepared to defend his decision.
Many scientists were concerned about the approval in December 1995 of
Schering-Plough Corp.'s Cedax, an antibiotic designed to treat children's
ear infections. The drug wasn't resistant against the three major pathogens
found in such infections, which made it less effective than other drugs on
the market and a potential hazard to increasing the spread of drug-resistant
bacteria. But instead of rejecting the drug, the FDA had the company write
a narrow label, warning that it wasn't effective against some bacteria.
The federal Centers for Disease Control was so concerned about the
approval that it complained to the FDA, saying that antibiotics less
effective than the ones on the market shouldn't be approved, says Scott
Dowell, head of a CDC group on drug-resistant bacteria.
The influx of money from user fees hasn't helped ease the agency's budget
problems, however. Since this money can be spent only on reviewing
proposed brand-name drugs, larger burdens have been placed on the rest
of the agency. There are more newly approved drugs, for instance, but still
a tiny staff to examine their safety after they reach the market.
Generic drugs don't benefit from user fees, and that review staff has had
steady cuts, an agency official says. And there is little money for blood
safety, Dr. Scribner says, even though HHS Secretary Donna Shalala has
said this is a top priority.
The Clinton administration said earlier this year that it would increase the
FDA's budget during the next fiscal year, but the recent budget resolution
suggests that any extra money for domestic programs will be distributed to
defense and education areas. The FDA doesn't have many constituencies
lobbying Congress for an increase. Businesses certainly don't want more
regulation, and some members of Congress still hold grudges against the
agency because they disliked former FDA Commissioner David Kessler,
who tried to get tobacco regulated as a drug.
"We are strangling the FDA to death, and someday we're going to realize
we have a corpse there," says Peter Barton Hutt, a former FDA counsel.
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