The NewStandard ceased publishing on April 27, 2007.

Drugmakers Hurry Sales, Delay Safety Studies*

by Michelle Chen

*A correction was appended to this news article after initial publication.

Feb. 7, 2007 – The federal government has admitted that pharmaceutical companies it is supposed to regulate have not yet made good on hundreds of promises to test the safety of drugs already approved for the market.

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According to a notice published Friday by the US Food and Drug Administration (FDA), from October 2005 through September 2006, companies had yet to initiate 71 percent of outstanding "post-market" safety evaluations that companies have promised to undertake for currently approved products they are already selling to consumers.

Under the Federal Food, Drug, and Cosmetic Act, the FDA can approve drugs despite unresolved safety concerns, but it can also require further studies by the manufacturer once a drug is released onto the market.

The FDA reported that of the 1,259 "open post-marketing commitments" tied to already-approved drugs, 899 were still "pending," meaning the studies had not yet begun. Only 15 percent of the studies were currently underway. Another 3 percent were officially behind schedule.

Within the year, only 160 post-marketing commitments were fully concluded with all study requirements met.

Drugmakers are supposed to set schedules for their study commitments and report regularly on their progress. But according to an audit by the inspector general of the US Department of Health and Human Services, the industry’s self-reported data are glaringly incomplete. Out of 2,353 post-market commitments from fiscal years 1990 to 2004, only 6 percent had listed start dates for studies; 21 percent had projected completion dates.

Watchdogs say companies can conveniently put off regulatory commitments while profiting from drugs that have not been proven safe.

Investigators tried to analyze 145 commitments designated as "fulfilled" in fiscal year 2004, but lacked sufficient data to assess the timeliness of all but 18. Of those, only three were completed within the planned timeframes.

Not all drugs approved by the FDA go through post-market evaluation. Current law allows the FDA to require post-market studies in certain cases – such as when treatments are approved under expedited procedures. For required post-marketing commitments, the FDA can withdraw a product if the manufacturer does not comply with "due diligence."

The agency negotiates other post-market commitments with companies individually, arranging follow-up safety assessments to be conducted after approval. These agreements, however, are not subject to the same enforcement regulations as legally required commitments.

The FDA does not consider "pending" study commitments to be off schedule, arguing that some studies may take a long time to begin due to their complexity. To consumer advocates, however, the latest figures suggest companies can conveniently put off regulatory commitments while profiting from drugs that have not been proved safe.

Bill Vaughan, senior policy analyst with the Consumers Union, told The NewStandard that once a drug is approved, "things move very slowly to resolve unanswered questions, and the public is at risk during that period."

In a 2005 investigation of open study commitments for fast-tracked drugs, the office of Representative Edward Markey (D–Massachusetts) determined that the time the products spent on the market before companies even initiated promised studies was on average 20 months. One drug, the skin treatment Sulfamylon, had been on the market for nearly seven years without the required assessment.

Legislation introduced by Markey in the last Congress would have enabled the FDA to order post-market studies once it received "evidence of a significant issue regarding the safety or lack of effectiveness of an approved drug." The bill, which never came to a vote, would also have ramped up enforcement by imposing civil penalties on manufacturers that fail to follow through on their study commitments.

Vaughan said the government’s current post-market enforcement authority is toothless. Pulling a drug from the market for safety reasons requires concrete proof of danger, he noted, and under existing rules, studies controlled and sponsored by the industry are key sources of such evidence. Ultimately, he said, regulators lack "resources to keep these guys honest as to whether they’re giving the public good science on the safety and the effectiveness of these drugs."


Minor Change:

The original version of this article stated that the audit by the inspector general of the US Department of Health and Human Services studied 2,353 drugs with postmarket commitments. In fact, the study covered 2,353 post-market commitments for an unknown number of drugs.

 | Change Posted February 9, 2007 at 01:22 AM EST

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The NewStandard ceased publishing on April 27, 2007.

Michelle Chen is a staff journalist.

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