President Clinton approves FDA reform bill

January 1, 1998

Pharmaceutical Representative

WASHINGTON - Nearly three months later than originally anticipated, the FDA Modernization and Accountability Act of 1997 became law.

WASHINGTON - Nearly three months later than originally anticipated, the FDA Modernization and Accountability Act of 1997 became law.

President Clinton signed the final version of the bill, which the pharmaceutical industry, the Food and Drug Administration and legislators had wanted to pass by Sept. 1, on Nov. 21.

"The word that we're getting from key health care policy people is that the President's happy with it," said Jeff Trewhitt, assistant vice president of communications for the Pharmaceutical Research and Manufacturers of America.

Legislators, most notably Sen. Ted Kennedy (D-Mass.), debated the bill's finer points for months. Kennedy alone fought for 26 amendments to the bill.

The final legislation includes a five-year renewal of the Prescription Drug User Fee Act, which will allow the FDA to collect as much as $600 million in user fees from pharmaceutical companies. It also facilitates access to experimental drugs for seriously ill patients, establishes a faster track for medicines and provides pharmaceutical companies with greater incentives to develop and test medicines for children.

The new law will speed drug approval times by an additional 10 to 16 months, according to Trewhitt. When added to the 12- to 15-month improvement that the original Prescription Drug User Fee Act made possible, time spent on the average 15-year drug approval process drops significantly. "By the turn of the century, patients are going to be getting new medicines two to two-and-a-half years faster than they did at the beginning of the decade," Trewhitt said.

In addition to renewing user fee collection, the new law allows companies more leeway to disseminate scientifically valid (but not FDA-approved) information about new uses for approved drugs. It also gives the FDA more flexibility as to how it may determine the effectiveness of a drug without weakening safety standards. PR

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