FDA Names New Device Chief
The Food and Drug Administration has named a new permanent head of the Center for Devices and Radiological Health. Dr. Jeffrey Shuren, who has been acting director since early September, will now direct the center. He replaces Dr. Daniel Schultz, who resigned last year after critics claimed he was too cozy with medical device makers. In a statement, the head of the device industry trade group Advanced Medical Technology Association (AdvaMed) applauded Dr. Shuren's appointment and said that he has already shown effective leadership skills. “His more than 10 years experience at FDA, in various high-level policy and planning positions within the commissioner's office, will serve him well as he takes control of an organization that oversees such a wide range of life-saving and life-enhancing products,” said AdvaMed CEO Stephen J. Ubl. The center also unveiled its strategic plan for 2010, with four priority areas: effectively regulating products throughout their development and marketing; enhancing communication and transparency; strengthening the center's workforce and workplace; and spurring innovation and addressing unmet public health needs. The strategic plan is available at
Access to Specialists a Problem
The Agency for Healthcare Research and Quality reports that 1 in 13 American adults who needed to see a specialist in 2007 said that getting access was a “big problem.” The data come from the Medical Expenditure Panel Survey. The survey found that 16% of adults without primary care physicians had problems accessing specialists, compared with 6% of those who had a usual source of primary care. Nonelderly uninsured adults had the most difficulty getting in to see a specialist, followed by nonelderly adults with public health coverage and those with private insurance. More data are available in the agency's report, “Variations in Perceived Need and Access to Specialty Care Among Adults in the U.S. Civilian Noninstitutionalized Population, 2007,” available at
www.meps.ahrq.gov/mepsweb/data_files/publications/st274/stat274.pdf
'Extraordinary' Drug Price Hikes
The Government Accountability Office said that 416 brand-name pharmaceutical products had “extraordinary” price increases from 2000 to 2008. While this represents only 0.5% of all brand-name products, most of the increases ranged from 100% to 499%, the GAO said in a report released in early January (GAO-10–201). More than half of those products were in three therapeutic classes: central nervous system, anti-infective, and cardiovascular. One possible reason for the price inflation, said the agency: The drugs are bought from wholesalers, repackaged, and resold at higher prices to physicians or hospitals. The Pharmaceutical Research and Manufacturers of America (PhRMA) industry group said that the report “focuses only on a small number of selected brand medicines rather than the entire prescription drug market.”
FDA Okayed 26 New Meds in 2009
The FDA approved 19 new chemical entities and 7 new biologics in 2009, according to Washington Analysis, a Washington–based investment adviser. Among the new chemical entities were Eli Lilly's oral platelet inhibitor Effient (prasugrel) and Sanofi-Aventis's antiarrhythmic drug Multaq (dronedarone). In his report, Washington Analysis' Ira Loss said that he expected more approvals this year because the agency claimed it wouldn't let statutory approval dates be overridden and it received more money for reviews.
Tobacco Prevention Funds Cut
Many states are severely cutting back on funding for tobacco use prevention programs, despite having collected huge revenues from taxes and the 1998 tobacco settlement, according to a report sponsored by the Campaign for Tobacco-Free Kids, American Heart Association, American Cancer Society Cancer Action Network, American Lung Association, and the Robert Wood Johnson Foundation. Overall, states will collect $25 billion in fiscal year 2010 but will spend only $567 million (2%) on prevention and cessation programs, the report said. Only North Dakota funds programs at the amount recommended by the Centers for Disease Control and Prevention; 31 states provide less than a quarter of the recommended level.