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Panel Urges FDA Overhaul
Panel Urges FDA Overhaul
Author: Ted Agres
9/25/06
nstitute of Medicine panel seeks major reforms at FDA, including bolstering intramural
and extramural research
A new report from the National Academy of Sciences' Institute of Medicine (IOM) recommends
strengthening the U.S. Food and Drug Administration's science capabilities by substantially
increasing intramural and extramural research within the agency and appointing a chief scientist
in the commissioner's office responsible for overseeing the agency's research programs.
The recommendation is one of 25 measures urged by the IOM in its long-awaited report on the
FDA. The report is deeply critical of the agency, stating that it is suffering from a "dysfunctional
organizational culture" that funnels resources into reviewing new drugs for market approval at the
expense of thorough monitoring of post-market safety.
Many of the report's recommendations, which were unanimously endorsed by the 15-member
panel of academics and other experts, focus on bolstering the agency's drug safety monitoring
and enforcement mechanisms. To strengthen FDA's ability to conduct post-market drug safety
assessments, the panel recommends creating a "robust program of intramural scientific
research," boosting information technology for drug utilization databases and other datasets, and
increasing extramural epidemiology research funding at the Center for Drug Evaluation and
Research (CDER) to $60 million annually.
"Clearly $1 million dollars-plus, which are the funds available currently for that kind of research,
is not adequate," Sheila Burke, IOM committee chair and chief operating officer of the
Smithsonian Institution, told reporters during a conference call on Friday.
Other measures recommended in the report include giving FDA greater authority to impose fines
and injunctions on drug manufacturers, requiring drug makers to conduct post-marketing risk
assessment studies, and having the agency review new drugs five years after they have been on
the market.
The report also recommends that drug companies intending to submit applications for new drugs
be required to register and post summary results of all Phase II through IV clinical trials on the
Internet, regardless of the outcomes.
During the first two years on the market, all new drugs would carry a black triangle or other
warning symbol, and FDA could ban or restrict direct-to-consumer advertising.
"A drug tested in a few hundred or a thousand people is certainly very much different when in
fact it is used by millions, often over much longer periods of time and in conjunction with other
drugs and supplements," Burke said. "Staff and resources devoted to pre-approval are
substantially greater than those available for post-approval functions. Few high-quality studies
are conducted after approval, and the data are generally quite limited."
Acting FDA Commissioner Andrew von Eschenbach, whose nomination to serve as
Commissioner is pending in the Senate, praised the report. "While considerable work has been
done over the past two years to improve our approach to drug safety, work still remains to be
done," he said in a statement.
The FDA requested the IOM study two years ago, following widespread criticism that the agency
and drug companies had mishandled safety issues surrounding COX-2 inhibitors, pediatric
antidepressants, and other drugs. While the FDA has authority to enact some of the
recommendations, most will require approval by Congress when legislators convene next year.
"The new report validates what the watchdog community has been saying for the last two years:
We need more vigilance over the lifecycle of drugs, the FDA needs to be more forthcoming with
information about drug risks, problems are systemic, and solutions must reflect a new mindset by
the agency's leadership," said Sen. Chuck Grassley (R-Iowa), chairman of the Senate Finance
Committee, in a statement.
Grassley and other critics have argued that a structural conflict of interest hinders FDA safety
officials from exercising authority, because the Office of Drug Safety is part of CDER, which also
houses the more powerful Office of New Drugs. The IOM report, however, stopped short of
endorsing that idea, recommending instead that Congress give the drug safety office a
"substantial" increase in funds and personnel. "It's difficult for us to say how much this would be,
but certainly more is better," Burke said, noting that the Office of New Drugs has about 1,320
staff members, while the Office of Drug Safety has only about 90.
The IOM also recommended that drug safety staff members be appointed to participate on
interdisciplinary teams involved in reviewing applications for new drugs. "New eyes often bring
new sources of ideas," said committee member Bruce Psaty, professor of medicine,
epidemiology, and health services at the University of Washington-Seattle.
Representatives of the pharmaceutical and biotech industries suggested that the report was
somewhat overzealous. "Though there is always room for improvements, it would be a mistake to
accept the notion that the FDA drug safety system is seriously flawed," said Caroline Loew,
senior vice president of the Pharmaceutical Research and Manufacturers of America, in a
statement.
Jim Greenwood, president of the Biotechnology Industry Organization, said his group supports
increased FDA funding to improve drug safety. But he added in a statement: "When considering
enhancements to the U.S. system, we must be cognizant that implementing undue hurdles in the
drug review process will harm patients by delaying access to life-enhancing and life-saving
products."
Ted Agres
tagres@the-scientist.com
Author: Ted Agres
9/25/06
nstitute of Medicine panel seeks major reforms at FDA, including bolstering intramural
and extramural research
A new report from the National Academy of Sciences' Institute of Medicine (IOM) recommends
strengthening the U.S. Food and Drug Administration's science capabilities by substantially
increasing intramural and extramural research within the agency and appointing a chief scientist
in the commissioner's office responsible for overseeing the agency's research programs.
The recommendation is one of 25 measures urged by the IOM in its long-awaited report on the
FDA. The report is deeply critical of the agency, stating that it is suffering from a "dysfunctional
organizational culture" that funnels resources into reviewing new drugs for market approval at the
expense of thorough monitoring of post-market safety.
Many of the report's recommendations, which were unanimously endorsed by the 15-member
panel of academics and other experts, focus on bolstering the agency's drug safety monitoring
and enforcement mechanisms. To strengthen FDA's ability to conduct post-market drug safety
assessments, the panel recommends creating a "robust program of intramural scientific
research," boosting information technology for drug utilization databases and other datasets, and
increasing extramural epidemiology research funding at the Center for Drug Evaluation and
Research (CDER) to $60 million annually.
"Clearly $1 million dollars-plus, which are the funds available currently for that kind of research,
is not adequate," Sheila Burke, IOM committee chair and chief operating officer of the
Smithsonian Institution, told reporters during a conference call on Friday.
Other measures recommended in the report include giving FDA greater authority to impose fines
and injunctions on drug manufacturers, requiring drug makers to conduct post-marketing risk
assessment studies, and having the agency review new drugs five years after they have been on
the market.
The report also recommends that drug companies intending to submit applications for new drugs
be required to register and post summary results of all Phase II through IV clinical trials on the
Internet, regardless of the outcomes.
During the first two years on the market, all new drugs would carry a black triangle or other
warning symbol, and FDA could ban or restrict direct-to-consumer advertising.
"A drug tested in a few hundred or a thousand people is certainly very much different when in
fact it is used by millions, often over much longer periods of time and in conjunction with other
drugs and supplements," Burke said. "Staff and resources devoted to pre-approval are
substantially greater than those available for post-approval functions. Few high-quality studies
are conducted after approval, and the data are generally quite limited."
Acting FDA Commissioner Andrew von Eschenbach, whose nomination to serve as
Commissioner is pending in the Senate, praised the report. "While considerable work has been
done over the past two years to improve our approach to drug safety, work still remains to be
done," he said in a statement.
The FDA requested the IOM study two years ago, following widespread criticism that the agency
and drug companies had mishandled safety issues surrounding COX-2 inhibitors, pediatric
antidepressants, and other drugs. While the FDA has authority to enact some of the
recommendations, most will require approval by Congress when legislators convene next year.
"The new report validates what the watchdog community has been saying for the last two years:
We need more vigilance over the lifecycle of drugs, the FDA needs to be more forthcoming with
information about drug risks, problems are systemic, and solutions must reflect a new mindset by
the agency's leadership," said Sen. Chuck Grassley (R-Iowa), chairman of the Senate Finance
Committee, in a statement.
Grassley and other critics have argued that a structural conflict of interest hinders FDA safety
officials from exercising authority, because the Office of Drug Safety is part of CDER, which also
houses the more powerful Office of New Drugs. The IOM report, however, stopped short of
endorsing that idea, recommending instead that Congress give the drug safety office a
"substantial" increase in funds and personnel. "It's difficult for us to say how much this would be,
but certainly more is better," Burke said, noting that the Office of New Drugs has about 1,320
staff members, while the Office of Drug Safety has only about 90.
The IOM also recommended that drug safety staff members be appointed to participate on
interdisciplinary teams involved in reviewing applications for new drugs. "New eyes often bring
new sources of ideas," said committee member Bruce Psaty, professor of medicine,
epidemiology, and health services at the University of Washington-Seattle.
Representatives of the pharmaceutical and biotech industries suggested that the report was
somewhat overzealous. "Though there is always room for improvements, it would be a mistake to
accept the notion that the FDA drug safety system is seriously flawed," said Caroline Loew,
senior vice president of the Pharmaceutical Research and Manufacturers of America, in a
statement.
Jim Greenwood, president of the Biotechnology Industry Organization, said his group supports
increased FDA funding to improve drug safety. But he added in a statement: "When considering
enhancements to the U.S. system, we must be cognizant that implementing undue hurdles in the
drug review process will harm patients by delaying access to life-enhancing and life-saving
products."
Ted Agres
tagres@the-scientist.com