The hypocracy is almost too much. First, FDA
promises the pharmaceutical industry to speed up the new
drug review process in exchange for tens of millions in
fees--money that the agency will spend to upgrade
technology, focus on counter-terrorism, and double its
number of staffers who oversee safety monitoring of
"FDA is looking for money to fund reviews of
post-marketing drug product evaluations," Susan
Cruzan, an FDA public affairs specialist, told me.
FDA currently reviews lifesaving drugs in six months and
most others in 10 months.
At a time when it is so expensive to review ever-more
complex drugs--and drug companies are discovering fewer of
them--FDA is getting fewer industry payments, contributing
to a $30 million hit this past year.
The agreement between FDA and industry would increase
user fee revenue from $160 million last year to $223
million next year and $260 million by 2007. The
additional fees will result in the drug industry paying
more than 51% of the costs to review and approve
Drug companies have already paid millions in user fees
that help fund FDA product reviews, under the Prescription
Drug User Fee Act (PDUFA). That law expires on
September 30 and Congress is now debating how, and
whether, to renew it.
Carl Feldbaun of Washington, DC-based Biotechnology
Industry Organization, an association representing biotech
companies, says the FDA/industry agreement benefits both
sides and "the patients waiting for new
"It is not uncommon to reach out to our
constituents," says Cruzan. "We are
working with industry to meet its needs and ours."
But Rep. Henry Waxman (D-CA) contends that the new
agreement between FDA and pharma does not provide enough
money for drug safety. He notes that industry is not
keeping promises to conduct further safety studies of
newly marketed drugs: A report delivered to Congress in
March shows that happens with only 37% of regular drugs,
15% of biotech products.
Which brings me to my second point: FDA just suspended
the Pediatric Rule, requiring safety testing of adult
medicines prescribed to children. Under the Best
Pharmaceuticals for Children Act (signed into law in
January), Congress reauthorized financial
incentives--six-month patent extensions--for manufacturers
to conduct those studies, via funding by the National
Institutes of Health. This move came after groups like the
Association of Physicians and Surgeons, Competitive
Enterprise Institute and Consumer Alert Group sued FDA for
requiring manufactures to perform their own studies.
FDA will spend the next two years deciding if the
Pediatric Rule incentives will stay in effect.
House Democrats complained to President Bush that the
action would halt "an important regulation that
protects children from potentially unsafe and improperly
dosed medications," adding that the new law is
"no substitute for requiring drug makers to perform
Cruzan even admits to me that the million dollar
question is whether or not this move shifts the burden of
testing to manufacturers. "The fact is that
manufacturers should always be testing their drugs and
their role is to obtain information on drug use," she
So, while on one hand, FDA claims it needs funds to
enhance safety monitoring of new drugs, the agency pulls a
complete 180 and disregards the safety of children for
already-approved drugs that were developed with adults in
mind. Does no one see the hypocracy here?
As a pharmaceutical reporter, I'm aware of obstacles
surrounding drug approval.
But as a parent, I'm outraged the FDA and pharma--would
for a second--consider testing medicines and vaccines
meant for children unnecessary!
Best Pharmaceuticals for Children Act
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