More Drug Firms Doing Follow-ups than Thought–FDA

By Susan Heavey
September 3, 2009

WASHINGTON – More pharmaceutical companies have completed studies required by U.S. health regulators after their products were allowed on the market than previously thought, according to an analysis released on Thursday.

But the study found that FDA database errors had obscured the issue, and critics said the post-approval studies, even when completed, still did not necessarily provide useful long-term information about the safety and effectiveness of the drugs.

Often, the Food and Drug Administration approves drugs and devices for sale on condition that companies keep studying the products for possible additional side effects or other issues.

For years, critics lamented such approvals because the FDA could only request more studies, but could not order them. The critics say companies had little incentive to do the studies once they won approval.

A 2007 law gave the agency more power to require the follow-up studies and ordered the analysis, which found more drug companies than previously thought had completed their studies. Results of the audit by Booz Allen Hamilton Inc [BOOZA.UL] were given to the FDA.

“Most companies are doing these studies and they are submitting the reports,” said Dr. John Jenkins, director of the FDA’s Office of New Drugs.

The audit found that of the backlog of 1,531 pending studies, about one-third, or 501, were actually completed, Jenkins told reporters in a conference call. The rest are in various stages of completion.

Still, Jenkins said that while 6 percent of the studies previously were considered delayed, the review found 15 percent were actually delayed.

Jenkins said the review, which did not look at devices, found that the agency had a number of problems in the database it uses to track such studies.

The report also found that while FDA is supposed to review submitted studies within a year, it only met that goal 23 percent of the time.

A recent infusion of funding from Congress should help alleviate that problem with extra staff, Jenkins said.

The audit found that most companies “take their obligations to conduct and complete … (studies) in a timely matter very seriously,” Jenkins said. “That fact was obscured in the past by inaccuracies in the FDA database, which led to criticisms that both industry and FDA and were not doing enough to ensure these studies were completed in a timely manner.”

But Diana Zuckerman, president of the advocacy group National Research Center for Women & Families, said even if companies finish such studies, the results don’t necessarily provide useful information. She said patients are not necessarily tracked as well as in trials done before approval.

“I’ve repeatedly seen longitudinal studies where more than half the patients have dropped out and nobody knows if they are alive or dead, healthy or sick,” she said. “So, the studies might be completed, and might be on time, but might not provide useful information on safety or effectiveness — which is what post-market studies are supposed to do.”

Peter Lurie, Public Citizen’s Health Research Group deputy director, said the FDA’s database is scrubbed each year, making it impossible to do any long-term analysis on how companies and the FDA are faring over time.

The Pharmaceutical Research & Manufacturers of America and the Biotechnology Industry Organization, industry groups that represent drugmakers, both welcomed the findings, which were posted on the FDA’s website.