Sweeping Changes Needed At US Food And Drug Administration
Jan Drew
Sweeping Changes Needed At US Food And Drug Administration
Five current or former members of the Drug Safety and Risk Management
Advisory Committee to the U.S. Food and Drug Administration (FDA) called
today for Congress to make sweeping changes to deal with a large number of
longstanding problems at the agency.
"The current FDA system of regulating drug safety has serious
limitations and is in need of changes," they say in Archives of Internal
Medicine, released today. Since Congress is ultimately responsible, "it is
up to Congress to take the steps necessary to reinvigorate the FDA's ability
to assure the public that approved medical products are safe."
Curt D. Furberg, M.D., Ph.D., professor of public health sciences at
Wake Forest University School of Medicine and the lead author, said the five
decided to write the analysis after becoming discouraged by the FDA's
inability to fix its own problems.
"Congress has not provided adequate funding and authority to the FDA,"
he said.
The group cites eight major problems impacting FDA performance,
including:
* The system of initial approval of drugs often fails to detect
serious adverse drug reactions.
* The same FDA center that approves drugs also has the responsibility
of taking safety actions, creating a conflict-of-interest situation.
* The FDA is overly dependant on user fees from drug companies.
* The FDA is short on expertise in drug safety and public health.
"The key features of today's media stories about questionable drug
safety are the same as with previous drug tragedies," Furberg said. "New
drugs are introduced on the market with inadequate safety documentation;
serious adverse drug reactions are later reported from the marketplace, and
a large number of patients are unnecessarily injured before the drugs are
withdrawn or better managed. The only difference is the name of the culprit
drug."
Furberg and his colleagues recommend that Congress make five changes:
* "Give the FDA more direct legal authority to pursue violations." The
FDA's own report says that drug companies committed to 1,231 post-marketing
safety studies that are incomplete; 797 were never started. * "Authorize the
adoption of a conditional drug-approval policy, at least for selected drugs.
* "Provide additional financial resources to support the safety
operations.
* "Mandate a reorganization of the agency with emphasis on
strengthening the evaluation and proactive monitoring of drug safety.
* "Require broader representation of safety experts on FDA's advisory
committees."
"Larger and longer clinical trials ought to be required for drugs that
will be given for chronic conditions such as high blood pressure, diabetes
and coronary heart disease," said Peter A. Gross, M.D., chairman of medicine
at Hackensack University Medical Center and professor of medicine and public
health at UMDNJ-New Jersey Medical School and a coauthor. "Trials should be
required to have adequate numbers to assure the tested drugs are reasonably
safe."
"Safety evaluation should be given the same priority as efficacy
evaluation," the authors wrote, calling for the creation of a Center for
Drug Safety within FDA "for continuous post-marketing surveillance and
regulation." They say the center should be given adequate funding and staff
to take advantage of the valuable data for safety monitoring already
collected in private and public databases.
The conditional drug-approval policy could be modeled on programs in
other countries for those drugs that have clear benefits but also have
lingering safety concerns, requiring a re-review after two to three years.
"A time-limited conditional approval status would place pressure on the
sponsors to conduct and report post-marketing safety studies they commit
to," said Furberg.
###
Arthur A. Levin, M.P.H., director of the Center for Medical Consumers
in New York, and a co-author, said the group was also calling for sufficient
funding to end reliance on user fees paid by the pharmaceutical industry,
calling the fees a conflict of interest. The Prescription Drug User Fee Act
requires FDA to "perform something of value to industry in exchange for
which industry would agree to pay the fees."
The co-authors also include Robyn S. Shapiro, J.D., of the Medical
College of Wisconsin in Milwaukee, and Brian L. Strom, M.D., M.P.H., of the
University of Pennsylvania in Philadelphia.
Wake Forest University Baptist Medical Center is an academic health
system comprised of North Carolina Baptist Hospital and Wake Forest
University Health Sciences, which operates the university's School of
Medicine. U.S. News & World Report ranks Wake Forest University School of
Medicine 18th in family medicine, 20th in geriatrics, 25th in primary care
and 41st in research among the nation's medical schools. It ranks 35th in
research funding by the National Institutes of Health. Almost 150 members of
the medical school faculty are listed in Best Doctors in America.
Contact: Robert Conn
Wake Forest University Baptist Medical Center
