Senate panel considers changes to drug review process

Improvements to the nation's drug approval and postmarketing regulatory processes were recommended by an array of witnesses.

By Susan J. Landers — Posted March 21, 2005

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Washington -- Recent controversies over the Food and Drug Administration's handling of risks associated with Cox-2 inhibitors and antidepressants for teens have triggered Senate scrutiny of procedures used by the agency to approve drugs and to review their safety once on the market.

For the vast majority of prescription drugs, a more streamlined package insert along with effective postmarketing surveillance would go a long way toward improving safety, said AMA Trustee Cecil B. Wilson, MD, who testified before the Senate Committee on Health, Education, Labor and Pensions at a March 3 hearing. The hearing was one of two days of consideration by the Senate panel.

Although package inserts are intended to inform physicians about the risks and benefits of a particular drug, instead they have become long and complicated legal documents, said Dr. Wilson, an internist in Winter Park, Fla. Such essentials as dosage, contraindications, major risks and potential drug interactions tend to get lost in the superabundance of information, he added.

The hearings were held to gather recommendations on ways to improve certain FDA drug approval and surveillance procedures that have been faulted for raising widespread confusion over the appropriate use of various medications.

"We need new and better ways to predict the safety and efficacy of new drugs before they enter widespread use," said Sen. Mike Enzi (R, Wyo.), chair of the HELP committee. "But we don't want to return to the days of drug lag, when desperate Americans waited for drugs that were available for months or even years in Europe."

Rapid increases in funding for biomedical research have resulted in an explosion of basic scientific knowledge that now promises to produce an avalanche of new therapies, Enzi said.

The AMA supports active postmarketing surveillance that includes well-designed studies on new drugs that could help to assess quickly any risks they might pose in clinical use, Dr. Wilson said.

In addition, Dr. Wilson cautioned the panel against restricting physicians' abilities to prescribe drugs off-label. "In some instances, prescribing a product off-label is the most appropriate therapy based on the latest, best scientific evidence -- and, in some patient populations, it may be the only treatment option," he said.

Safety review board

The FDA's ability to monitor the safety of drugs on the market would be greatly improved with the establishment of an independent Center for Drug Safety within the agency, said Bruce M. Psaty, MD, PhD, co-director of the University of Washington's Cardiovascular Health Research Unit in Seattle.

This new center could be authorized to compel manufacturers to revise product studies, to conduct new studies, to suspend sales and to withdraw drugs in a timely fashion, Dr. Psaty said.

Enzi indicated that congressional action would be forthcoming to "address the current shortcomings in our drug approval system."

Such legislation could provide the FDA the authority to order manufacturers to re-label drugs when clear safety concerns arise, said Sen. Edward M. Kennedy (D, Mass.), the panel's ranking minority member. He added that the two years it took to re-label Vioxx after a clinical trial pointed to its cardiovascular dangers for some patients was "disgraceful."

It is also essential that the FDA be given the clear authority to require manufacturers to conduct safety studies after a drug has been approved, Kennedy said. In addition, he expressed concern that label warnings seem to have little effect on the safer use of drugs. "Some experts question whether re-labeling is ever effective. FDA may well need better ways to encourage or even require safe use of drugs," he said.

The usefulness of the FDA's MedWatch reporting system for adverse drug reactions has been characterized as "fundamentally a 1950s approach," Dr. Psaty said. It lacks many features of high-quality epidemiologic studies such as validation of events by standard criteria and comparable assessment of drug use and risk factors. "The state of this system stands in stark contrast to the enormous expansion of the pharmaceutical industry during the past several decades," he said.

The FDA has taken steps recently to provide emerging information on drug risks and benefits to physicians and patients, noted FDA Acting Commissioner for Operations Janet Woodcock, MD, in testimony.

The agency announced last month that it planned to develop a new Drug Watch Web page that will include the newest information about safety risks for previously and newly improved drugs. The agency also said it would create a Drug Safety Oversight Board composed of staff members from the FDA and other federal health agencies to help monitor drug safety.

Questions also were raised at the hearing on the wisdom of allowing direct-to-consumer advertising, which Dr. Woodcock called a "double-edged sword." While such ads can alert people to new treatments, the same ads might not convey a product's risks, she said.

Plus, FDA research has shown that some physicians do prescribe drugs for patients because patients have asked for them, Dr. Woodcock said. But "the construct that we are working under is that physicians are the learned intermediaries and will decide after a conversation with the patient whether a particular drug is appropriate for that patient and that condition."

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Improving drug safety

In testimony before the Senate's Health, Education, Labor and Pensions Committee, the AMA provided the following recommendations for improving drug safety and minimizing the impact on physicians' ability to practice medicine:

  • Take active approaches to postmarketing surveillance by conducting well-designed studies on newly marketed drugs that could help to assess quickly their risk in clinical use.
  • Encourage the Food and Drug Administration to issue a final rule modifying the content of drug package inserts. In 2000, the FDA issued a proposed rule to make package inserts more user-friendly for physicians.
  • Preserve the practice of off-label prescribing because such medication use is often necessary for optimal patient care.
  • Develop better risk communication vehicles and approaches in collaboration with physician organizations to further reduce risks carried by medications.

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External links

Testimony from the U.S. Senate Committee on Health, Education, Labor and Pensions' March 3 hearing on drug safety (link)

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