FDA, drug companies, reach agreement on user fees

<br>WASHINGTON (AP) _ The Food and Drug Administration and the drug companies it regulates have reached a tentative agreement that would increase the user fees the companies pay. <br><br>The increased

Thursday, March 7th 2002, 12:00 am

By: News On 6

WASHINGTON (AP) _ The Food and Drug Administration and the drug companies it regulates have reached a tentative agreement that would increase the user fees the companies pay.

The increased fees would allow the FDA to hire additional staffers to review drug applications and speed up their processing.

The user fees were authorized by the Prescription Drug User Fee Act, which was passed in 1992 and is now up for renewal.

The tentative agreement was disclosed Wednesday by Deputy FDA Commissioner Lester M. Crawford at a hearing by the House Energy and Commerce health subcommittee.

The agreement is currently under review by the Bush Administration before being sent to Congress. It could form the basis for a renewal of the user fee act, which expires Sept. 30.

During its operation, the fees collected under the act have enabled the FDA to speed up its review process and bring more prescription drugs and biological products on to the market, Crawford said.

Median approval time for priority new drug and biologic applications dropped from 13 months in 1993 to six months in 2000, Crawford said.

But, while he did not give details, Crawford said that in the last three years the costs of the reviews have exceeded the income from user fees , with the shortfall reaching $30 million this year.

``Establishing a fee structure to ensure that income covers the cost of enhancements to the drug and biologic products review process ... is what we are working to address,'' Crawford told the committee.

Crawford also said there is a need for increased monitoring of new drugs once they are on the market.

During their development drugs are tested on a few thousand people, but once approved they can go to millions, raising the potential for adverse reactions not seen during the tests.

There has been no increase in the number of drugs withdrawn since the approval process was speeded up, he said. But careful monitoring is still needed.