April 24

GAO Report Gives FDA Flunking Grade in Detecting Drug Dangers

A highly critical report by the Government Accountability Office about FDA drug safety evaluation and monitoring found the agency’s performance "disorganized," "bureaucratic," and undermined by infighting between drug evaluation administrators whose allegiance is with industry, and the Office of Drug Safety. The GAO criticized the way the agency’s safety experts were prevented from speaking at important advisory committee meetings on drugs they were studying.  The report noted the considerable turnover—eight drug safety office directors in the past 10 years.

FDA’s drug safety office is depicted as “a junior bureaucratic partner, sometimes ignored or dismissed by the new-drugs bureau.” The GAO report said the safety office "serves primarily as a consultant" to the Office of New Drugs "and does not have any independent decision-making responsibility."

FDA’s budget allocation confirms the low standing of the safety office. The agency has 715 employees and a $111-million budget: the safety office, which has 106 employees, gets a mere $27-million budget.  The GAO noted that FDA’s new Drug Safety Monitoring Board, which was established on the heels of the Vioxx catastrophe, does not address the major issues. 

The consequences of the lack of clout the safety division has can be documented by the number of  preventable drug-related injuries and deaths: Prior to 1992 when Congress passed a law, the Pharmaceutical Drug Users Fee Act (PDUFA), FDA’s safety standards were better than today. Between 1975 to 1999 (25 years) sixteen drugs had to be withdrawn from the market because they were lethal.[1]   Of these 9 were withdrawn within the first 18 years; 7 were withdrawn between within 7 years (Januray1993 and December 2000), after they had been linked to at least 1,002 deaths.[2]

FDA’s safety record shows a continuing disregard for the public’s life safety. Since 2000, TEN drugs have been withdrawn from market AFTER they killed thousands of people.

Two million people are injured annually from prescribed pharmaceuticals–106,000 die from adverse prescription drug effects–in addition to 98,000 drug related deaths in hospitals due to errors. [3]

The LA Times reports, “GAO investigators found that the new-drugs bureau and the safety office repeatedly got bogged down in bickering over what the data mean. These scientific disputes can continue for months, even years.”  These are not legitimate disputes about data, these disputes favor industry’s marketing goals. FDA-CDER administrators (the new drugs bureau) protect the business interests of drug manufacturers. It should be noted that this bureau’s budget is dependent on Pharma user fees. Thus, the culture at CDER is not about to change in favor of drug safety.

Indeed, Dr. Alistair Wood, a prominent voice on the FDA’s advisory panel on drug safety and risk management, told the Washington Post that the GAO report "confirmed a lot of what people have been saying for some time.  Frankly, it doesn’t look right now as if much has changed."

Congressman Joe Barton, chair of the House Energy & Commerce Committee, who had requested the GAO report, spoke in forked tongues when he mischaracterized the report: "The GAO report shows that the drug-safety system is not in crisis, but the FDA’s process may need some fine-tuning.” On the contrary, the report is critical of FDA’s systemic failures and its culture that trivializes drug safety concerns and disregards the agency’s safety division. The culture at FDA’s new drug bureau is a reflection of the culture within the industry the agency shields rather than oversees.  Congressman Barton’s effort to trivialize the GAO findings is most disturbing: his predecessor as chair, Cong. James Greenwood, accepted a lucrative post with Biotechnology Industry Organization on the eve of a scheduled committee hearing when pharmaceutical executives were scheduled to be grilled. [See:https://ahrp.org/infomail/04/07/20.php] 

It will be up to the citizenry to decide whether preventable deaths from deadly drugs are acceptable.  We need an independent drug safety office removed from the long tentacles of drug manufacturers who currently wield decisive influence at the FDA, resulting in the agency’s ‘Devil may care’ attitude about loss of lives that could be prevented by allocating resources into monitoring the safety of widely prescribed drugs. 

Dr. Curt Furberg, a professor of public health sciences at Wake Forest University School of Medicine, told The New York Times [below] the GAO report confirms the agency’s disregard for safety: "The F.D.A.’s office of drug safety has absolutely no clout and no money, and the report showed that."


1.  Lasser KE, et al "Timing of New Black Box Warnings and Withdrawals for Prescription Medications," JAMA, May 1, 2002, 287:2215-2220
2.  Willman, D. "How a New Policy Led to Seven Deadly Drugs" Los Angeles Dec 20, 2000, Front page, http://www.latimes.com/news/nation/reports/fda/lat_fda001220.htm
3. Langreth, R. Just Say No, FORBES Nov. 29, 2004  http://www.forbes.com/forbes/2004/1129/102_print.html

See also:
Kaufman, M. FDA Is Criticized Over Drugs’ Safety Problems, The Washington Post:  http://www.washingtonpost.com/wp-dyn/content/article/2006/04/23/AR2006042300958.html
Rubin, R. Report questions FDA’s safety procedures  USA Today, http://www.usatoday.com/news/health/2006-04-23-fda-safety_x.htm

Contact: Vera Hassner Sharav

Los Angeles Times
Drug Safety Still Seen as Lagging
A year after announcing reforms, the FDA still doesn’t have a reliable system to keep track of developing problems, a federal report says.
By Ricardo Alonso-Zaldivar, Times Staff Writer
April 24, 2006

WASHINGTON — More than a year after the Food and Drug Administration announced it had strengthened its drug safety system, the agency still lacks a reliable system for keeping track of emerging problems, congressional investigators concluded in a report to be released today.

The Government Accountability Office found that a new Drug Safety Oversight Board and other FDA initiatives were "unlikely to address all the gaps" in the agency’s system for monitoring the long-term safety of prescription drugs approved for market.

Although the board may help straighten out high-profile cases, the GAO said, day-to-day oversight of safety issues is still hampered by poor information, lack of legal authority to order drug company studies, and bickering between the powerful FDA bureau that reviews drugs for approval and a smaller safety office depicted in the report as a bureaucratic stepchild.

The safety office "serves primarily as a consultant" to the Office of New Drugs "and does not have any independent decision-making responsibility," the report said. In some cases, it found, the new-drugs bureau has excluded safety officers from presenting their findings to scientific panels that the FDA relies on for advice.

With eight directors of its safety office in the last 10 years, the FDA "has not effectively overseen post-market drug-safety issues, and as a result, it is unclear how [the agency] can know that important safety concerns have been addressed and resolved in a timely manner," the report said.

It is too early to tell whether the report will provide a boost for stalled legislation to beef up the FDA’s safety office and make it an independent center within the agency.

Although GAO investigators outlined a long list of unresolved problems, they also credited the FDA for working to make improvements. In a statement, the FDA vigorously disputed the finding that its safety office plays a secondary role.

Two key lawmakers who had requested the GAO inquiry were divided in their reactions to the report.

"The GAO report shows that the drug-safety system is not in crisis, but the FDA’s process may need some fine-tuning," said Rep. Joe L. Barton (R-Texas), chairman of the House Energy and Commerce Committee, which oversees the pharmaceutical industry.

A spokesman said Barton would wait for a National Academy of Sciences report due this summer before deciding whether to pursue legislation.

But Sen. Charles E. Grassley (R-Iowa), a co-author of the FDA reform bill, said the findings by the GAO’s nonpartisan investigators bolstered his proposal.

Grassley had held widely publicized hearings into the FDA’s failure to identify the heart risks of Vioxx, despite warnings from its safety office. The hearings followed an unexpected decision by manufacturer Merck to withdraw the painkiller, which had racked up blockbuster sales and profits.

"At the Vioxx hearing, some said there was a crisis at the FDA and others said everything is all right," Grassley said. "This report provides solid evidence that everything is not all right…. The FDA’s problems are systemic and cultural, not isolated or easily fixed."

In preparing their report, GAO investigators interviewed FDA scientists and managers and reviewed internal documents usually not provided to the public. Meetings of the drug safety board, for example, are closed.

The FDA’s oversight problems begin with spotty data, investigators found. The agency’s Adverse Event Reporting System, which relies heavily on voluntary reports from doctors, captures only a tiny fraction of bad reactions to drugs.

And in most cases, the agency lacks legal authority to order manufacturers to conduct follow-up safety studies once a drug is approved. (Grassley’s bill would grant the agency such authority.)

Drug data should soon start becoming more complete, investigators said, because the FDA has obtained $10 million in funding from Congress to tap into health insurer databases and other sources. Better information, however, is no guarantee that oversight will improve.

GAO investigators found that the new-drugs bureau and the safety office repeatedly got bogged down in bickering over what the data mean. These scientific disputes can continue for months, even years.

The FDA’s drug-safety decision-making process is complex, investigators said, involving a repetitive back-and-forth between the two offices, often over the same points.

"Several [safety office] staff characterized this as … falling into a ‘black hole’ or ‘abyss,’ " the GAO report said.

It depicted the safety office — with 106 employees and a $27-million budget — as a junior bureaucratic partner, sometimes ignored or dismissed by the new-drugs bureau, with 715 employees and a $111-million budget.

The chief of the new-drugs bureau reports directly to the head of the FDA’s Center for Drug Evaluation and Research. The director of the safety office must go through another supervisory level before reaching the head of the center.

The FDA disputed the finding that the safety office played merely a consultant role, saying that the two offices are equally respected and that 51% of the work of the new-drugs bureau involves safety.

The GAO looked closely at four cases in which the FDA encountered safety problems after a drug had been approved for use by patients. Not surprisingly, it took longer to resolve instances in which the two offices disagreed.

One drug for rheumatoid arthritis, Sanofi Aventis’ Arava, remains on the market nearly four years after the safety office recommended that it be withdrawn because of concerns it could cause serious liver problems and even death.

Reviewers at the new-drugs bureau strongly disagreed that reported cases of liver injury among patients were linked to the drug. At a 2003 scientific advisory panel meeting, the new-drugs bureau refused to let the safety office present its data, questioning their scientific merit, the report said.

Arava remains on the market, albeit with stronger warnings about liver risk.

Congressional investigators said the FDA needed to set up a more effective system for settling such disputes between the two offices.


Congressional Investigators Are Critical of F.D.A.’s Efforts to Detect Drug Dangers

WASHINGTON, April 23 — Disorganization, bureaucratic infighting and an inability to force drug makers to conduct needed safety tests have undercut efforts at the Food and Drug Administration to uncover drug dangers, government auditors say.

When drug safety specialists raise alarms about certain medicines, they sometimes feel that their recommendations fall "into a ‘black hole’ or ‘abyss’ " at the agency, according to a report to be released Monday by the Government Accountability Office, the auditing arm of Congress.

Top agency officials sometimes excluded drug safety specialists from presenting findings at public hearings, and tensions between officials who approve drugs and those who ensure that they are safe are common, the report said.

"F.D.A. lacks clear and effective processes for making decisions about, and providing management oversight of" issues involving the safety of popular medicines, the report states.

The F.D.A. told the accountability office that its conclusions were "reasonable," the report said.

Last year, the agency created a drug safety oversight board and asked the Institute of Medicine to examine its drug safety practices. The institute’s report is due in July. The accountability office said in its report that the agency’s responses so far might help "but will not address all gaps."

Susan Bro, an F.D.A. spokeswoman, said, "The F.D.A. welcomes the G.A.O. report and is currently leading a comprehensive and timely effort to transform the methods our medical and scientific staff use to manage safety issues."

The report comes after a series of drug withdrawals led agency critics and some on Capitol Hill to suggest that the agency was failing in its mission to protect the public from dangerous drugs. Since 2000, pharmaceutical companies have withdrawn 10 drugs after deaths and other injuries belatedly demonstrated that the medicines were unsafe.

Many critics have said that the agency should never have approved these drugs for sale in the first place.

Senator Charles E. Grassley, an Iowa Republican who is chairman of the Senate Finance Committee, said the accountability office’s report showed that "the F.D.A.’s problems are systemic and cultural, not isolated or easily fixed."

But Representative Joe L. Barton, a Republican from Texas who is chairman of the House Energy and Commerce Committee, said the report "shows that the drug safety system is not in crisis, but the F.D.A.’s process may need some fine-tuning."

The auditors recommended that Congress vote to give the agency power to force drug makers to undertake or complete drug safety studies. Mr. Grassley has proposed legislation that would do that.

When it approves new drugs for sale, the drug agency often requires manufacturers to study whether the medicines are working as intended and whether they have unwanted side effects once they get into a broader market.

But the agency announced in March that two-thirds of these promised studies had not even been started, and hundreds of trials have been pending for years.

In many cases, pharmaceutical makers had guaranteed they would undertake the studies as a way to speed their drugs’ approval.

The Bush administration has opposed efforts to give the agency greater authority to force drug makers to complete these trials, and top agency officials have for years told Congressional committees that the agency did not need any additional authority.

"One senior F.D.A. official and several outside drug safety experts told us that F.D.A. needs greater authority to require such studies," the accountability office’s report says.

Dr. Alastair Wood, associate dean of the Vanderbilt medical school, said the report demonstrated that the drug agency needed more authority and should create an independent department that evaluates the safety of medicines. "It confirms that the current system needs fixing," Dr. Wood said.

The report said the agency lacked the money needed to construct an effective system to monitor the safety of marketed drugs.

Much of the drug agency’s functions are financed by fees paid by drug makers, but the industry mostly opposed proposals that would have allowed the agency to use this money to determine whether already approved medicines cause unexpected injuries or deaths. And neither the administration nor Congress has provided enough money to make up the difference.

The accountability office’s report said that the drug agency’s budget to undertake its own studies of drug dangers amounted to less than $1 million annually from 2002 to 2005, and that this figure was expected to rise to only $1.1 million annually through 2010.

Just one clinical trial to study the long-term safety of one drug can cost as much as $7 million, the report said.

"I think the report is terrific," said Dr. Curt Furberg, a professor of public health sciences at Wake Forest University School of Medicine. "The F.D.A.’s office of drug safety has absolutely no clout and no money, and the report showed that."

Copyright 2006 The New York Times Company

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