The NewStandard ceased publishing on April 27, 2007.

FDA Looks to Renew Industry-Funded Review Process

by Shreema Mehta

Apr. 5, 2007 – Congress is set to reauthorize a Food and Drug Administration act that critics say gives drug companies too much influence over the agency, leading to hasty approvals of new drugs.

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Under the Prescription Drug User Fee Act (PDUFA), first implemented in 1992, pharmaceutical companies pay the FDA to review new drugs. To finance a larger staff that can speed up the drug approval process, the FDA charges a range of fees, from $400,000 to $900,000 per application, depending on whether the drug requires a trial. This year, the FDA expects to receive about $300 million from drug companies to review new drugs.

Consumer groups say the Act has allowed drug companies to leverage their financial contributions to negotiate deadlines for reviewing new drugs, television commercials, fee amounts and other policies with the FDA.

Every five years, the FDA submits a plan for reauthorization of PDUFA to Congress.

To draft the plan, the FDA consults scientists, academics and consumer groups, then engages in what critics call "closed-door negotiations" with the pharmaceutical and biotechnology industries.

FDA spokesperson Sandy Walsh told The NewStandard the FDA receives input from various "stakeholders," including industry representatives, consumer advocates and health-provider groups. "We certainly meet more frequently with the industry because it is the industry we regulate," she added.

The GAO found that after PDUFA was passed, safety reviewers had greater workloads and often forwent training activities so they have more time to meet PDUFA goals.

For 2008, the FDA’s goal is to review and decide on at least 90 percent of new drugs within six to ten months after submission. FDA officials would also respond to requests for meetings with members of the pharmaceutical or biotechnology industry within two to three weeks of receiving the request.

Over the past decade, the deadlines for evaluating drugs have been moved up and reviewers have had less time to test a drug. In 1995, the FDA’s goal was to review only 55 percent of submissions within 12 months. In 1998, the FDA raised the goal to reviewing 90 percent of new drugs within 12 months.

George Washington University School of Public Health and Health Services professor and former FDA staffperson Susan Wood said performance goals set by PDUFA for every authorization put "intense pressure" on individual reviewers and the agency as a whole to review drugs quickly to meet deadlines.

"The user fees have made the agency too responsive and concerned about meeting deadlines that benefit the big drug companies, and they forgot who their real clients are, which is the American public," said Bill Vaughan, a senior policy analyst with Consumers Union.

Walsh of the FDA defended the fees. "While biotech and pharmaceutical companies serve in an advisory role in the PDUFA process, FDA maintains high standards for reviewing drug and biologic marketing applications, and in assessing the safety of products that are already on the market," she said. "FDA employees are dedicated to their public-health mission, regardless of the source of funding." 

The number of drugs withdrawn from the market for safety reasons has increased after PDUFA.

But a report released in 2002 by the Government Accountability Office found that the quicker deadlines mandated by the second authorization of PDUFA has led to shorter review periods that may have led to an increasing number of drugs withdrawn from the market for safety reasons.

The GAO found that after PDUFA was passed, safety reviewers had greater workloads and often forwent training activities so they have more time to meet PDUFA goals.

The number of drugs withdrawn from the market for safety reasons has increased after PDUFA. According to the GAO, the increase in the number of newly approved drugs, as well as the increasing number of people taking prescription drugs, likely caused these withdrawals.

Though Consumers Union is pushing for reforms to PDUFA, such as shifting some funds toward monitoring drugs after they’ve reached the market to test for long-term dangers, Vaughan and other consumer advocates such as Public Citizen and US Public Interest Research Groupsay the Act should be withdrawn altogether. They say taxpayer dollars should fund drug-safety reviews in order to avoid conflicts.

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The NewStandard ceased publishing on April 27, 2007.


Shreema Mehta is a staff journalist.

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