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Home » Current News » September 23, 2006

Report States FDA Drug Safety System is Broken
Institute of Medicine Calls for Greatly Increased Funding, Warning Labels
and a Moratorium on the Advertising of New Drugs; also Recommends a
Greater Role for Public Input on Drugs and Devices

September 23, 2006 -- In a sweeping critique of the way in which the U.S. Food and Drug Administration (US FDA) currently monitors the safety of drugs, a blue ribbon panel of the Institute of Medicine (IOM), part of the National Academies, has issued a 350 page report that concludes:


" Lack of clear regulatory authority, chronic underfunding, organizational problems, and a scarcity of post-approval data about drugs' risks and benefits have hampered the U.S. Food and Drug Administration's ability to evaluate and address the safety of prescription drugs after they have reached the market..."

A Reaction to Vioxx
The report was commissioned by the FDA itself In the wake of problems found with a number of drugs that had been approved, but subsequently were found to have serious adverse effects. A major example was the Vioxx story and the three-year time lag between the time when independent researchers found problems and the drug's withdrawal. As Dr. Eric J. Topol, whose team discovered the link between Vioxx and heart attacks, wrote in an Op-Ed piece in the New York Times on October 2, 2004 ("Good Riddance to a Bad Drug"):

"After three years of denying that the arthritis drug Vioxx could induce heart attacks and strokes, this week Merck bowed to reality: it withdrew Vioxx from the market. The impact of this decision is far-reaching, and not only because tens of millions of people have tried Vioxx. It also highlights the absence of Food and Drug Administration oversight of the pharmaceutical industry as well as the lack of comprehensive long-term studies of not only Vioxx but its entire class of arthritis drugs."

Eric Topol's Criticism Echoed
Now, two years after, Dr. Topol's essay was published, his specific criticisms are being confirmed by the National Academy of Sciences. The report states that most of the FDA's financial resources are put into the process of approving a new drug, but very little into monitoring what happens in the population after the drug goes to market. Serious side-effects and adverse events may not occur in the relatively small group of patients used to gain the drug's approval, even though that group is closely watched. But when those adverse reactions start occuring in the population at-large, they are not revealed because there is no adequate means of tracking them in place.

As R. Alta Charo, a panel member and bioethicist at the University of Wisconsin at Madison, stated to the Washington Post:

"...patients who participate in drug trials are carefully selected, and hardly typical of patients in the real world who usually suffer from more complex problems. 'A drug tested in a few hundred or thousand people is very different when used by millions, especially over long periods of time and in conjunction with other supplements...'

Eschenbach Defends FDA
The FDA reacted to the report with a tentatively defensive posture. Acting Commissioner Eschenbach stated in a press release that the FDA "appreciates" the Institute's work and several times refers to efforts within the FDA that are already underway to address these problems. He concedes that, "while considerable work has been done over the past two years to improve our approach to drug safety, work still remains to be done" and he defended the Agency, stating:

"With regards to strengthening FDA let me take a moment to recognize the dedicated staff who serves [sic] at FDA. I'd like to specifically commend the staff of the Center for Drug Evaluation and Research for the important role they play and job they do each and every day"

Senator Grassley Responds
By far the most stinging rebuke of the FDA, as well as its reaction to the report, came from Iowa's Republican Senator Charles E. Grassley who has chaired investigations of the FDA in the past. In a press statement Grassley stated:

"Vioxx was like a dead canary in a coal mine, a warning that worse may yet come. Today there’s no question left that we need to strengthen post-market surveillance in order to improve drug safety and save lives. The new report validates what the watchdog community has been saying for the last two years: We need more vigilance over the life-cycle of drugs, the FDA needs to be more forthcoming with information about drug risks, problems are systemic, and solutions must reflect a new mind-set by the agency’s leadership. Remember, the FDA only grudgingly requested this report to assess drug safety.

Additionally, in a letter to Acting Commissioner Eschenbach, Grassley painted a picture of the FDA's employee culture that differed significantly from Eschenbach's commendation to the staff:

"I have worked to give voice to the concerns of a number of rank-and-file scientists and FDA managers who share a common complaint: a deep-seated cultural divide exists within the FDA, and it has led to systemic problems that plague the agency. Together we have shed sunlight on how frequently differences of scientific opinion are quashed, the nature of the cozy relationship between the FDA and the industries it is supposed to regulate, and the failure of the agency to be adequately transparent and accountable to the public.... An agency that hemorrhages whistleblowers is an agency needing critical care.... I am very troubled by FDA’s attempts to suppress scientific dissent by muzzling its own scientists. Such actions by the FDA show a lack of respect for the dedicated scientists working at the agency and a lack of respect for the scientific process.

Senator Grassley continues:

In the face of such criticism, the FDA appears to be focused on damage control rather than addressing its core problems. As a science-based agency, the FDA is remarkable for its lack of introspection, second-guessing, and failure to assess its own performance and capabilities in a systematic way...the FDA comes off as an agency in denial that chooses to keep its head in the sand in the hope its problems will go away.

Recommendations for Change
The Institute of Medicine's report is not all criticism. It contains a comprehensive list of recommendations for realigning the way in which drugs are monitored and calls for greatly increased funding from Congress, new enforcement powers for the FDA, and special cautionary labeling of newly approved drugs so that patients know if they are taking a drug that, although approved, has not yet had a long history of use (a plan currently in place in the U.K.). Additionally, pharmaceutical firms would be prohibited from marketing Direct-To-Consumer (DTC) newly approved drugs until their safety in a wide population has been established.

As for the impact of these recommendations on the medical device industry (balloons, stents and defibrillators) a subject more germane to readers of Angioplasty.Org, tucked away on page 149 of the IOM report is this recommendation for all centers within the FDA, drugs, research and devices -- a separate advisory committee on consumer issues that would enhance the value of and provide a mechanism for the public's experience:

...the committee believes that a separate, external entity is needed to advise the agency on the diverse communication needs of the public and patients and on the best evidence on risk communication tools and strategies. Several FDA centers, including CDER, the Center for Biologics Evaluation and Research, and the Center for Devices and Radiological Health share similar communication challenges. An advisory committee on consumer and patient communication issues could have a dual function, serving as a conduit for public input into FDA's decision making (for example, through surveys), and an advisor to the agency on a range of communication issues.

The big question now is what Congress and the Executive Branch will do towards putting these recommendations into practice. Stay tuned....


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