FDA, Drug Companies Dropping Ball on Follow-Up Studies

TC · medicine forum Guru Joined: 02 May 2005 Posts: 1814

http://abcnews.go.com/Health/wireStory?id=1684277

FDA: Drug Companies Drop Ball on Studies

By ANDREW BRIDGES

WASHINGTON Mar 3, 2006 (AP)- Drug companies have yet to even begin
nearly two in three of the follow-up studies they agreed to undertake
once their medicines were on the market, according to a government
tally released Friday.

Often the drugs received expedited approval from federal regulators on
condition that the studies be carried out.

The Food and Drug Administration said in an annual report that, as of
Sept. 30, 65 percent of the 1,231 so-called "post-marketing" drug
studies that companies had pledged to carry out were still pending.

"That doesn't mean they will never be started," said Dr. John Jenkins,
director of the FDA's Office of New Drugs, explaining that 116 of the
797 studies were committed to during the 12 months ending in September.
The clinical trials required under the commitments can take six months
to a year to design and launch, he said.

Some studies had been committed to years earlier, but the FDA didn't
provide a breakdown.

The 797 pending studies represent a slight dip from the 812 still
pending as of a year earlier, according to FDA documents. FDA
spokeswoman Kathleen Quinn said the agency feels that "these numbers
show drug companies are taking this thing seriously."

Dr. Alastair Wood, associate dean of Vanderbilt Medical School, said if
the FDA doesn't require the studies to be done, it shouldn't ask for
them in the first place.

"It's astonishing, really. Their job is to get the studies done and not
be an apologist for their not getting done," Wood said.

Alan Goldhammer, of the Pharmaceutical Research and Manufacturers of
America, an industry group, said the figures should not be "distorted."

"To be clear, pending does not mean delayed. It does mean, however,
that the immense and vitally important tasks of developing research
protocols, finding investigators and researchers and even recruiting
patients to participate in the study is in process," Goldhammer said.

Dr. Jerry Avorn, a Harvard Medical School professor and author of
"Powerful Medicines," in which he criticizes the FDA's post-marketing
system, said the numbers show the system is broken.

"This new information is an embarrassing continuation of similar
reports issued by FDA each year on the appalling state of the
medication safety studies it has 'mandated' drug manufacturers to
perform. It is scandalous that of the supposedly active studies, about
two-thirds haven't even been started yet," Avorn said.

The FDA says it relies on the so-called Phase 4 studies to gather
additional information about a drug's safety, efficacy or use. The
outcome of those studies can lead to changes in how a drug is made,
prescribed and used. The FDA also can require the studies after it has
approved a drug, including to better determine its safe use in
children.

The report, posted to the FDA Web site, lists 231 studies as ongoing,
28 as delayed and three as terminated as of Sept. 30. Another 172
studies are listed as completed or terminated, with a final report
submitted to the agency.

The report also tallies studies required of biological products, which
include vaccines, blood components and transplant tissues. There, of
321 study commitments, 118 or 37 percent remained pending as of Sept.
30. Another 56 were completed by that date.

Sen. Charles Grassley, R-Iowa, and Sen. Christopher Dodd, D-Conn.,
introduced legislation last year that would give the FDA added
authority to require drug companies to carry out studies of their drugs
once they've been approved and are being sold.

The FDA plans to award a contract in coming weeks to evaluate and
improve the process of how the studies are developed and implemented,
Quinn said.

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TC

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