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FDA OKs Speedier Medication Reviews

Updated:
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.
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