Surgery News - November 2007 - (Page 14)

14 PRACTICE TRENDS SURGERY NEWS • N O V E M B E R 2 0 0 7 Act Raises Agency Accountability FDA • from page 1 enhanced safety monitoring, according to Sen. Edward Kennedy (D-Mass.), who toiled with Sen. Enzi to craft a compromise with the House-passed legislation. The agency has an “urgent need for these funds,” said Sen. Kennedy in a statement. “Since 1990, the number of adverse events submitted to the FDA has increased by over 1,300%, but the agency’s resources have increased only 130%.” The new law seeks to increase FDA accountability in many ways. In a much-an- tions, providing about 25% of the FDA’s annual budget; thus, they “are vitally important to the agency and its continued ability to protect and promote the public health,” said FDA Commissioner Dr. Andrew von Eschenbach in a statement after the bill passed both the House and Senate in late September. The law would give the FDA almost $400 million in fiscal 2008 and in each of the next 4 years for review of medical devices and drugs, and at least $50 million for ticipated move, Congress expanded the agency’s authority to require drug and device makers to disclose clinical trial data to the public. The aim is for consumers to be able to search a clinical trials registry for basic information on the trial’s purpose, where it’s being conducted, and its outcomes goals. In addition, if it is an FDAapproved product, consumers should be able to learn whether it succeeded or failed, and whether the intervention has been the subject of FDA safety inquiries or warnings, or any other public health advisories. The law also gives FDA the power to levy civil fines on manufacturers if they do American College of Surgeons 94th annual Clinical Congress October 12–16, 2008: San Francisco, CA Moscone Convention Center Save the Date! Join us in San Francisco for the 94th annual Clinical Congress. As always, it will be an educational opportunity you won’t want to miss! Please be sure to visit www.facs.org in the coming months for more details regarding the educational program, registration, housing, and transportation. not submit the data according to established deadlines. The agency, working with the National Institutes of Health, will phase in the system, said Dr. Janet Woodcock, FDA Deputy Commissioner and Chief Medical Officer, in a briefing with reporters. Some in Congress also had hoped to require a risk evaluation and mitigation strategy to be implemented for most newly approved drugs. Currently, only a handful of drugs are subject to these strictures, most notably isotretinoin and thalidomide. Under the new law, the FDA will be given leeway to decide when such programs are necessary and what form they will take. Companies that do not comply can be fined up to $1 million. The agency also will have more power to order postmarketing clinical trials. However, it is not clear yet whether FDA will have to issue rules to implement these new powers, according to Randall Lutter, FDA’s Deputy Commissioner for Policy. Congress renewed and expanded incentives for drug makers to study their products in children through the reauthorization of both the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act. Under the Pediatric Research Equity Act, the FDA can require companies to submit data on pediatric populations when they seek approval for a new dose, new route of administration, new active ingredient, or new indication. The FDA also was directed to form an internal committee to review and track these “pediatric assessments” submitted by drug makers. Under reauthorization of the Best Pharmaceuticals for Children Act, drugs studied in pediatric populations will continue to be granted 6 months of additional patent life, rather than the 3 months sought by some legislators. On the device side, in addition to user fees for product reviews, the law also directs Congress to appropriate $7-$8 million annually for collecting, developing, reviewing, and evaluating postmarket safety information. The FDA also must issue rules to require each medical device to carry a unique identifier. The FDA sought comments on such a system in August 2006, but had not yet issued a rule. At the time, the American College of Cardiology said identifiers could help track adverse events. The medical device trade group AdvaMed said that use of identifiers should be voluntary, since there is no solid evidence that they will actually contribute to patient safety. Congress also included incentives for medical device makers to test their products in children through the Pediatric Medical Device Safety and Improvement Act, which is modeled after the two pediatric drug programs. The law calls for several new studies in the medical device area, including one to examine the incidence of nosocomial infections related to the reprocessing of single-use devices and sterilization of reusable devices. In addition, the agency is being directed to determine whether current warnings used in tanning booths provide enough Continued on following page http://www.facs.org http://www.facs.org http://www.facs.org

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Surgery News - November 2007 Contents Black Patients Fare Worse Than Whites After Liver Surgery Survey Suggests Need For Acute Care Surgery New Law Bolsters FDA Funding, Authority Working Together Oncology: Marginal Evidence? Trauma: Screening Scrutinized News From the College: Healy Takes Helm

Surgery News - November 2007

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