Filed at 7:31 p.m. ET
WASHINGTON (AP) -- More than half of the product research that
drug companies routinely promise as a condition of sales approval
has yet to begin, the Food and Drug Administration said Thursday.
The good news is that companies are fulfilling commitments on
drugs given special fast-track approval to treat life-threatening
diseases before there's final proof they really work, the FDA said.
Post-marketing research can be crucial for tracking troublesome
side effects and, in the case of fast-track drugs, proving a
medicine that alleviates symptoms goes on to lengthen lives.
The FDA has long come under fire for not tracking how much of
that promised research actually gets done.
Thursday, the FDA provided a count and a Web site where the
public can search how well companies fulfill their commitments.
Among the findings:
--Some 60 percent of 1,339 promised post-marketing studies of
drugs have not begun, nor have 30 percent of 223 promised studies of
biological therapies. Some of those studies have stalled for years.
--Many times, FDA didn't set a deadline. Among those that had
deadlines, 2 percent of the drug studies and 8 percent of the
biological studies are classified as delayed.
--Among fast-track drugs, half of the promised post-marketing
studies already are completed, 28 percent have not begun, and 1.6
percent are officially delayed.
``It shows there's room for improvement,'' by companies and FDA,
said Dr. John Jenkins, director of FDA's Office of New Drugs.
Dr. Sidney Wolfe of the consumer advocacy group Public Citizen
called the findings grim, saying there are too many unanswered
safety questions about big-selling drugs because FDA didn't impose
deadlines.
FDA's only recourse if a company balks at a promised study is to
pull the drug off the market, which it is reluctant to do. Wolfe
wants the FDA to seek congressional authority to impose large fines
on companies that stall.
The pharmaceutical industry called the findings ``largely good
news.'' The percent of truly delayed studies ``is very small,'' said
Alan Goldhammer of Pharmaceutical Research and Manufacturers of
America.
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On the Net:
Post-marketing study commitments: http://www.fda.gov/cder/pmc/