Filed at 8:31 a.m. ET
WASHINGTON (AP) -- The Food and Drug Administration has reached
agreement with the drug companies it regulates on steps that might speed
review of new medications, in return for tens of millions in new
industry fees.
The industry has long funded a significant portion of the FDA's drug
review work. But for the first time, Wednesday's agreement would allow
some of that money to go to improved safety monitoring of new drugs --
allowing the FDA to eventually double its number of staffers who oversee
the risks of newly sold therapies.
Health and Human Services Secretary Tommy Thompson called that part
of the deal essential to protecting public health.
``The measures described in these recommendations would benefit all
concerned -- the FDA, the companies developing new therapeutics and,
most importantly, the patients waiting for those new products,'' said
Carl Feldbaum of the Biotechnology Industry Organization.
But drug safety advocates say some of the proposal is worrisome. In
wake of a dozen drugs pulled off the market because of dangers in recent
years, critics say the FDA already is approving drugs too fast and
doesn't adequately monitor problems that can arise when new ones hit the
market.
Rep. Henry Waxman, D-Calif., is concerned that the new agreement
doesn't provide enough money for drug safety. His office notes that
industry already isn't keeping promises to FDA to conduct further safety
studies of newly marketed drugs: A report delivered to Congress
Wednesday shows that happens with only 37 percent of regular drugs and
15 percent of biotech ones.
And Dr. Sidney Wolfe of the consumer advocacy group Public Citizen
said the FDA should be keeping drugs off the market until they're proven
safe instead of letting companies try to manage risks with warnings that
too often go unheeded.
Drug companies have paid millions in user fees that help fund FDA's
review of their products since 1992, under a law called the Prescription
Drug User Fee Act, or PDUFA. That law expires on Sept. 30 and Congress
is beginning debate on how to renew it.
At the same time, it is costing more to review ever more complex
drugs -- and companies are discovering fewer of them, meaning the FDA is
getting fewer industry payments. The result is a shortfall that reached
$30 million this year, the FDA told Congress last week.
Wednesday, the FDA sent Congress a letter outlining agreements with
industry on how it would spend fees if Congress renews the law -- fees
that would increase from $160 million last year to $223 million next
year and nearly $260 million by 2007.
If the new fees are approved, the drug industry says it will be
paying more than 51 percent of the costs of reviewing and approving
medications.
The FDA says it already reviews lifesaving drugs in six months and
most others in 10. But in return for the funds, the FDA agreed to some
changes that might add more speed, including ``rolling reviews'' where
the FDA renders a decision on one part of a new drug application even as
final studies of the medicine are still under way.