Tc
Mon, Mar-06-06, 17:16
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.
Ds. 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.
***********
TC
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.
Ds. 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.
***********
TC