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, AMNews staff. March 21, 2005.

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."