A congressional-staff review found that pharma companies have failed to complete about half the studies ordered by the FDA as part of the agency's accelerated-approval system for new drugs.
The review was conducted by Rep. Edward Markey (D., Mass.) and focused on the accelerated-approval program, which requires pharma companies to continue studying an approved drug after it goes to market.
An FDA spokeswoman told the Wall Street Journal that agency officials could not comment on the report because they had not seen it.
To complete the review, the Markey staff used FDA and Securities and Exchange Commission data examining 91 studies ordered on 42 products approved from 1993 to October 2004. The accelerated-approval process was established in 1992.
Of the 91 studies, 46 have been completed, 42 haven't and three have been delayed.
Half of the unfinished studies had yet to begin, with the oldest outstanding study ordered in 1996 for Shire's Proamatine to treat fainting in patients with low blood pressure. A Shire spokesman told the Journal the company acquired marketing rights to the drug in 2000 and agreed to do two studies, one of which is complete and another, which is ongoing.
"It is outrageous that drug companies and the FDA have been dragging their feet when it comes to conducting required postmarketing studies," Markey said in the Journal report." They are laughing at the FDA, and sometimes it seems as if the FDA is treating it as a joke as well."
Markey has proposed introduction of a bill that would give the FDA more authority to write drug labels and to state in them when a drug receives accelerated approval, alerting doctors and patients that a drug is undergoing additional study. He also said he hoped the measure would establish fines of as much as $1 million a day for failing to conduct timely postmarketing studies.