Executive Briefing Series (formerly The Food & Drug Letter)

Due to the Christmas and New Year’s holidays there was no issue of The Food & Drug Letter published on Dec. 31, 2004.

Drugmakers and the FDA have faced intense scrutiny in recent months over safety concerns involving some widely marketed drugs.

As it is configured now, the FDA is incapable of preventing another Vioxx-type drug withdrawal, according to an agency drug safety reviewer who has called for an independent drug safety office within the FDA — a proposal that has the backing of a powerful Republican senator and others who argue the FDA has lost its objectivity in dealing with the drug industry.

Two-thirds of FDA scientists said they lacked confidence in the agency’s ability to adequately monitor the safety of drugs on the market, according to a 2002 survey that appears to back up recent criticisms of the FDA’s system for approving and monitoring prescription drugs.

The FDA has commissioned the National Academies’ Institute of Medicine (IOM) to evaluate the U.S. drug safety system and assess the agency’s role in delivering safe and effective drugs to the public.

Recent warnings about the safety of several popular pain medications include:

Vioxx: Merck announced in September 2004 a worldwide withdrawal of the arthritis drug Vioxx after clinical studies found an increased risk of heart attack and stroke in patients taking the treatment.

The Senate Finance Committee plans to continue its investigation into how the FDA oversees the safety of marketed drugs despite calls by some who contend the issue falls under the jurisdiction of the Senate Health, Education, Labor and Pensions (HELP) Committee.

A new FDA commissioner is needed to correct alleged problems involving drug safety at the agency, according to a Democratic senator.

The flurry of high-profile controversies involving the safety of prescription drugs has added pressure on lawmakers to enact legislation that would give Congress greater oversight of the FDA, according to a Washington observer.

Some critics of the FDA allege the reliance on industry-paid user fees has created a “cozy relationship” between the agency and drugmakers that may have contributed to recent drug safety problems, but FDA officials and industry observers say user fees are not to blame.

Merck and the FDA are facing multiple probes into the events surrounding the firm’s abrupt withdrawal of its profitable arthritis pain drug Vioxx.