Vanderbilt Medical experts propose
FDA drug approval changes

Newswise — Efforts to reform drug regulation in the wake of the Vioxx withdrawal do not go far enough, according to experts at Vanderbilt University Medical Center.

Writing in this week’s New England Journal of Medicine, Wayne Ray, Ph.D., and C. Michael Stein, M.B., B.Ch., call for the establishment of three independent centers in charge of drug approval, post-marketing studies and drug information, and for a ban on direct-to-consumer advertising for the first three years after a drug is marketed.

“Medications approved on the basis of studies of a few thousand patients are rapidly marketed to millions of patients, setting the stage for ‘drug disasters,’” they wrote.

“Subsequent litigation generates billions of dollars in legal fees and settlements that ultimately become part of the cost of new medications. This haphazard process does not benefit the public health, the medical profession or the pharmaceutical industry.”

Ray is professor of Preventive Medicine and Stein is associate professor of Medicine and Pharmacology. They and their colleagues at Vanderbilt helped document the increased risk of heart attacks and strokes associated with Vioxx use.

“The present system of drug regulation is susceptible to the influence of conflicts of interest,” Ray and Stein wrote. “There is evidence of bias in the design and conduct of post-marketing studies funded by the pharmaceutical industry … Current procedures for effective and impartial communication … to practitioners and patients are inadequate.”

To help solve these problems, the Vanderbilt researchers recommend the establishment of three centers funded with a tax on pharmaceutical sales: A Center for New Drug Approval to regulate the initial licensing of new drugs; a Center for Post-marketing Studies to oversee mandatory post-approval studies conducted by independent investigators; and a Center for Drug Information to communicate “accurate, unbiased information” to doctors and patients.
They also propose “selective phased release” of some new medications to protect patients until independently conducted post-marketing studies establish their safety and effectiveness.

This approach may actually improve access to drugs.

“Limiting the use of a new medication until the population that would benefit from it is better defined might permit a drug that otherwise would have been withdrawn to be kept on the market,” Ray and Stein write.

Implementing these proposed reforms will not be easy, the researchers conclude, “but the costs of inaction are unacceptable.”

“Each new drug disaster causes preventable morbidity and mortality, undermines the credibility of the public health infrastructure, erodes patients’ confidence in physicians and fuels costly litigation,” they write. “Prompt and effect reform is essential.”