Is the FDA good enough?

February 1, 1999

Pharmaceutical Representative

Does the United States need an independent drug safety board to investigate FDA-approved medicines?

Does the United States need an independent drug safety board to investigate FDA-approved medicines?

Two esteemed academics think so, and they have published their opinions in the New England Journal of Medicine, Vol. 339, No. 25.

In "Making Medicines Safer - The Need for an Independent Drug Safety Board," Alastair Wood, M.D., of Vanderbilt University Medical Center, and Raymond Woosley, M.D., of Georgetown University Medical Center, argue that the FDA cannot objectively investigate adverse reactions to drugs after the drugs have been approved for marketing.

Currently, the FDA is responsible for monitoring adverse reactions to approved drugs as well as for evaluating new medicines for marketing clearance. The agency accomplishes this by way of its voluntary reporting system, formally organized under its yearling Office of Post-Marketing Drug Risk Assessment.

Wood and Woosley argue: "FDA staff members involved in the approval process spend a large amount of time, often as much as a year, reviewing an application. Therefore, their recommendation for approval involves substantial personal identification with that approval, and it is unlikely that those who recommend a drug for approval could later conduct a dispassionate evaluation of possible harm due to that drug."

Instead, the authors wrote, a post-marketing drug safety board should be formed "independent of both the drug manufacturers and the FDA, both of which have clear conflicts of interest." The agency would be responsible for monitoring the effect of drugs on patients after new drugs were introduced to the market.

Renewed opposition

Woosley and Wood are not the first to suggest the idea. A panel at the National Academy of Sciences recommended the creation of such a board more than 20 years ago, and the call has been raised periodically ever since.

One likely reason for this latest revival is an unusually high number of product recalls. Within a year, the FDA pulled the heart medicine Posicor, the antiobesity agent Redux and the painkiller Duract from pharmacy shelves because of reportedly dangerous side effects.

"I think it's safe to say that three recalls in a year is close to the highest, if not the highest, number of recalls in one year," said Jeff Trewhitt of Pharmaceutical Research and Manufacturers of America However, he attributed the greater number of recalls to the greater number of medicines that reaches the market thanks to the Prescription Drug User Fee Act. The fees raised as a result of the legislation enabled the FDA to hire more reviewers and, in turn, helped speed the drug approval process. It did not, Trewhitt averred, compromise safety standards at the FDA.

"Not one safety rule has been changed or modified [since user fees were introduced]," Trewhitt said. "The requirements of safety for the FDA have expanded [since then]."

The FDA has been proactive in regard to reviewing safety measures as well, Trewhitt said. The fact that the FDA pulled the products from the market demonstrates that it is paying close attention to drug reaction and is engaged in careful post-marketing surveillance, he argued. And, although the agency believes its review process for pending drug approvals is sound, it plans to conduct a comprehensive internal review of safety measures.

Given this diligence, he continued, the industry does not need another regulatory agency to provide checks and balances. "Before we start throwing money at a new bureaucracy, let's find out what the problem is," Trewhitt said.

The FDA also opposed the notion of an independent board, saying its safety officers had sufficient expertise and objectivity to monitor drugs after they have been cleared for marketing.

An example to follow?

The authors repeatedly compared the need for an independent drug safety board to the air travel industry, citing the separation of agencies within that industry as a model example.

In the air travel industry, the Federal Aviation Administration sets standards for airlines, but the National Transportation Safety Board investigates airline accidents. The NTSB can find fault with airlines or with the standards of the FAA, and it has the authority to recommend changes.

For example, the authors wrote: "Even though substantially fewer people were killed in the crash of Trans World Airlines Flight 800 than were affected by the adverse drug reactions [cited in the article], a much more thorough investigation of the crash has taken place than of any of these drug reactions."

In addition to forming an independent investigative agency, the authors suggested the following:


•Â Formal, post-marketing surveillance should be routine and mandatory.


•Â The newly formed drug safety board should gather and analyze comparative data.


•Â The value of the endpoints for marketing approval should be confirmed by evidence that a product reduces morbidity or mortality. PR

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