Senate Passes Bill to Speed Drug Approval

The Senate on Wednesday passed and sent to President Bush legislation that would speed government approval of “breakthrough” drugs by requiring pharmaceutical companies to help pay the cost of testing them.

The bill, which has been endorsed by the Bush Administration and was passed by voice vote, is expected to enable the Food and Drug Administration to make available more quickly new drugs to fight AIDS, cancer, Alzheimer’s and Parkinson’s diseases and other illnesses.

The measure, passed by the House early Tuesday, represents a compromise between the Administration, Congress and the industry over how to provide the FDA with the funds it needs to hire more product analysts without bloating the federal budget deficit.

Until this year, lawmakers and pharmaceutical companies had opposed the plan on the grounds that not all the monies collected under previous versions of the bill would have gone directly to the FDA’s own budget. Under the present legislation, however, the agency would get it all.

The measure requires pharmaceutical-makers seeking FDA approval for new prescription drugs to pay stiff user fees, based initially on the number of new applications and later on the number of manufacturing plants and new products.

The fees, which range from $5,000 to $233,000 depending on the size of the company, are expected to raise an estimated $337 million over five years--enough to increase the FDA’s current $120-million-a-year budget by an average 50% a year during the period.

In return, the FDA already has agreed to hire up to 600 new reviewers to help speed approval of applications. FDA chief David A. Kessler also has promised to streamline the agency’s approval process to cut review times almost in half.

Congressional sources said Wednesday that the legislation could bring the approval time for “breakthrough” drugs against catastrophic diseases to as little as six months. Standard applications will be processed in about 12 months.

The difficulty in obtaining fast approval of new prescription drugs has become a sore point among patients and medical care providers. With sweeping improvements in biotechnology, the number of applications for FDA approval of new products has almost doubled in the last decade.

At the same time, the squeeze in federal spending has crimped the FDA’s ability to process the applications.