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U.S. Department of Health and Human Services


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Concerns Have Been Raised About The Effects Of PDUFA

Table of Contents: Managing the Risks From Medical Product Use: Creating a Risk Management Framework

Previous Section : Legislative and Management Initiatives have helped Speed Review Time

In the late 1990s, Public Citizen's Health Research Group and others began to express the concern that PDUFA's focus on shortening the review time has altered relationships among FDA's reviewers, FDA management, and the regulated industry. Critics have charged that time pressures resulting from PDUFA have led to a decrease in the quality of FDA reviews. To investigate this possibility, Public Citizen conducted a survey of FDA reviewers. Of a total of 172 surveys mailed, 53 responses were received. Nineteen medical officers reported that their recommendations to disapprove a product had not been followed. Although the survey design did not allow the collection of information on how frequently this had occurred, when these specific reviews had been conducted, or how many reviews had been conducted by each survey respondent, the survey nonetheless raised a serious charge: Pressures to speed reviews, pressures to approve, and scientific disagreements among reviewers and managers have reduced the quality of FDA reviews, resulting in poor decisions that, in turn, have led to an increase in unanticipated adverse events.

The ensuing public discussion has highlighted the fact that medical products are not 100 percent safe, and even after extensive evaluation, products are not always fully understood. It is widely accepted that enormous benefits can be gained from using medical products. Yet, while most are well tolerated, producing only minimal side effects or rare adverse events, some products can be very toxic, producing a high rate of complications from side effects. It is estimated that millions of adverse events associated with the use of medical products occur each year; many of these are serious, and many result in death.1

Recent increased scientific and media attention to serious adverse events resulting from the use of medical products has raised questions about the risks associated with the use of those products. Medical product quality has not been the focus of concerns.2 Concerns have focused on serious adverse events resulting from the use of medical products after the products are on the market. And, although many participants are involved in managing the risks from medical product use, when serious adverse events do occur, the public often turns to the FDA for answers.

Next Section : The Commissioner asked the Task Force  to look into Public Concerns about the Risk Management System