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FDA Under Scrutiny |
PROLOGUE
How To Get The Data? Scrutiny Of Postmarketing Surveillance At The FDA
How do we prove that our drugs and therapeutic devices are safe? This has been the core mission of the U.S. Food and Drug Administration (FDA) since its founding in the first decade of the twentieth century. Recent events in the wake of Merck’s withdrawal of Vioxx and the return of silicone breast implants have subjected the FDA’s approval procedures and postmarketing surveillance to intense scrutiny. Congress, newspaper and journal articles, bloggers, and even stockholders have questioned whether the FDA is capable of upholding its mission. Do we need to strengthen the postmarketing surveillance group within the FDA? Do we need a new organization within the FDA? Or should we create an entirely new agency? In an attempt to answer the growing chorus of criticism, in May 2005 the FDA created a Drug Safety Oversight Board within its Center for Drug Evaluation Research to improve information gathering and dissemination.
The following two papers attempt to pinpoint the problem within the FDA’s surveillance process and propose some solutions. They both focus on the quality and timeliness of the information that comes into the FDA after a drug or device has been on the market, and they find that information lacking. David Malenka, a cardiologist at the Dartmouth-Hitchcock Medical Center, and his coauthors Aaron Kaplan, Sandra Sharp, and John Wennberg describe the controversy that arose about adverse events related to drug-eluting stents. They then use a case study with Medicare data on bare-metal stents to portray how incorporating Medicare data for postmarketing surveillance could have been used to identify risk and potential adverse events for patients undergoing stenting.
Scott Gottlieb, a fellow at the American Enterprise Institute who has served as a senior policy adviser to the FDA and the Centers for Medicare and Medicaid Services (CMS), focuses on the information and information systems available throughout the FDA. Gottlieb rejects calls for a new structure within or outside of the FDA but notes how data collection has been underfunded throughout the agency, leaving its postmarketing surveillance group with little information; what information is there is of varied quality. He advocates greater investment in information technology and infrastructure at the FDA and cooperation between government and industry in data collection. Both authors call for better coordination and collaboration between the FDA, CMS, and other stakeholders. As the agencies consider eligibility for many new drugs and devices including carotid stents, the proposals in these two papers take on added urgency for the FDA in its mission to ensure the safety of drugs and therapeutic devices.
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