Senate Votes For FDA Modernization/PDUFA Bill

The US Senate Labor and Human Resources Committee has approved, by a14-4 vote, the Food and Drug Administration modernization/ Prescription Drug User Fee Act reauthorization bill. Four of the panel's eight Democrats joined with the Republican majority to approve the bill, which was less controversial than that proposed in the last Congress. The bill now moves to the full Senate for floor action; the House has yet to deal with its similar legislation.

The bill would focus FDA resources on higher-risk drugs and devices, and allow it to contract with qualified outside examiners for safety and efficacy reviews. It expands humanitarian access to drugs still undergoing approval, and makes it easier for the FDA to approve a drug for additional indications, eg for pediatric use. It will give thousands of people faster access to new drugs while retaining important FDA oversight responsibilities, said committee chairman James Jeffords. There is a risk in approving unsafe drugs and also in not approving safe drugs that improve and save thousands of lives, he said, adding that the bill is a good balance.

Health claims for foods would be presumed to be authorized if they were based on and consistent with the findings of a federal agency or the National Academy of Sciences; the Senate panel defeated by 13-5 an amendment from Ted Kennedy to strike health claims provisions. John Cady, president of the National Food Processors Association, said this is a win for consumers and the food industry, and called for commonsense reforms to better enable companies to provide important information to consumers about the health benefits of various foods. Existing rules discourage the use of such claims on food labels, he said, and the current system of FDA review and approval of such claims has led to lengthy delays in getting this important information to consumers.