WASHINGTON - February 15 - The FDA should put a hold on its proposed user-fee deal with the pharmaceutical industry until specific safety benchmarks are included, such as investigating all serious drug adverse-event reports and taking action against companies that fail to perform promised safety studies, Consumers Union said.

“Consumers should get the same tough deliverables on safety, just like the pharmaceutical industry gets on drug approvals,” said Bill Vaughan, senior policy analyst for Consumers Union, publisher of Consumer Reports. “When it comes to ensuring drug safety and effectiveness in this agreement, you have to ask ‘where’s the beef?’ ”

The FDA is holding a public hearing Friday on its proposed agreement with the drug industry to extend the Prescription Drug User Fee Act, or PDUFA. Congress first passed PDUFA in 1992 to speed up drug approvals by having the industry help fund the approval process. The original act has been extended twice and is slated to expire this year unless Congress reauthorizes it (PDUFA IV).

Some of the safety goals Consumers Union is requesting the FDA include:

• Investigating all serious adverse event reports within 15 days, and conduct a set amount of investigations per year into patterns or clusters of adverse event reports to determine if more action should be taken.

• Levying monetary penalties against at least 50 percent of the drug applicants who have failed to complete follow-up safety studies or trials.

• Doubling the audits of clinical trial data and Investigational Review Board applications to ensure the ethical treatment of enrollees in drug trials and the sponsor’s compliance with good scientific practice.

• Requiring drug trials for a set amount of medicines being used off-label to determine if they are safe and effective for that use. A recent report estimated that 21 percent of 160 commonly prescribed drugs are prescribed off-label, and in 73 percent of the cases, there was little or no scientific support for that use.

“The industry gets 90 percent of new drug applications decided within a certain number of days, and requests for meetings answered within two weeks. But what does the public get?” Vaughan said.

To read the complete testimony, click here

The proposal calls for industry to pay $393 million annually to the FDA, an increase of $87 million over the previous PDUFA agreement. Of the increase, $29.3 million is earmarked for drug safety efforts over the life-time of a drug.
“The $29 million in increased funding for safety is a start, but it’s woefully inadequate,” Vaughan said. “The Institute of Medicine called for more than $100 million in new safety and scientific resources.”

Vaughan said if a user-fee system is necessary to help fund the drug approval process because of pressures on the budget, then there should be no strings attached to the money. Many FDA employees have said the current system of having the industry fund FDA operations is having a corrupting influence on the agency’s safety responsibilities.

“We strongly endorse legislation that has been offered in the past by Congressman Maurice Hinchey that proposes any FDA revenues derived from the regulated industry not be burdened with conditions on their use set by the industry,” he said.

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