College Overhauls CME
The American College of Cardiology announced that it is abandoning its current model for continuing medical education at scientific sessions, essentially to segregate industry-sponsored symposia from other sessions. The college “was prompted in part by ongoing concerns about real and/or perceived bias in interactions with industry, specifically related to non-independence of certified satellite symposia,” said the group in a statement. There will be two educational tracks starting with next year's annual scientific session: One will have in-depth sessions developed by the ACC, and the other will be made up of uncertified satellite symposia. The latter can be industry sponsored and will be managed through the ACC's business development division. The policies guiding those seminars will be consistent with the Food and Drug Administration's and other regulatory agencies' rules governing industry-sponsored CME. “The move is important because it will allow for transparency in the two separate approaches and meet the educational needs of our members,” said Dr. Rick Nishimura, cochair of the college's 2012 annual scientific session next March.
Advocacy for Cardiology
The ACC's advocacy committee issued its five policy priorities for 2011. No. 1 is to overhaul the physician payment system by – among other efforts – repealing the Sustainable Growth Rate formula for Medicare payments. No. 2: Make sure cardiologists are part of new care-delivery plans stemming from health reform, such as Accountable Care Organizations. Third is tort reform, and the advocacy committee's fourth priority is to help ACC members get ready to meet meaningful use criteria for health information technology. Finally, the committee said that it would also stay on top of coding changes, imaging-accreditation requirements, and the FDA's device-safety initiatives.
FDA Device Review Questioned
The Government Accountability Office said that the FDA has not done enough to ensure the efficiency and effectiveness of its recall procedures for high-risk medical devices. Back in January 2009, the GAO found fault with the 510(k) device-approval process and recalls. The agency is again urging the FDA to quickly issue final rules to more strictly and clearly regulate 510(k) devices. Since the 2009 report, the FDA has published a strategic plan but issued a final rule on only one type of device, the GAO said. The agency is not collecting data that would let it identify risks posed by devices, even though 3,510 were voluntarily recalled for problems in 2005-2009, said the GAO. “Taken together, GAO's preliminary work suggests that the combined effect of these gaps [in the FDA's recall process] may increase the risk that unsafe medical devices could remain on the market,” said the new report.
FDA Sued Over Generic Lipitor
Generic drugmaker Mylan has sued to force the FDA to speed up the introduction of generic versions of Pfizer's blockbuster drug Lipitor (atorvastatin). Mylan and its Indian partner, Matrix Laboratories, said they could be ready to sell generic atorvastatin in late June. The companies claim the FDA must allow generic versions to enter the market then because Pfizer's key patent on Lipitor expires that month. Rival generic drugmaker Ranbaxy Laboratories has agreed in a patent settlement with Pfizer to wait until Nov. 30 to bring generic atorvastatin to market, when Ranbaxy expects to have exclusive rights to market the generic for 6 months. However, Ranbaxy may not be ready to market its product by November, pushing back Mylan's generic introduction even further, the company said in its lawsuit. In addition, Mylan claims that Ranbaxy may have violated FDA rules in submitting its application, making it ineligible for the 6-month, exclusive-rights period for atorvastatin.
Medicine Has Economic Power
Office-based physicians contributed $1.4 trillion in economic activity in 2009 and supported 4 million jobs nationwide, according to a report from the American Medical Association. The report, prepared by the Lewin Group, calculates the state-by-state impact of the 638,000 office-based physicians in the United States. In total, they provided $833 billion in wages and benefits and generated $63 billion in state and local tax revenues in 2009, the report said. On average, each office-based physician supported $2.2 million in economic output and 6.2 jobs, including his or her own.
Medical Boards Fail on Discipline
State medical boards failed to discipline more than half of doctors who either lost their clinical privileges or had them restricted by the hospitals where they worked, according to a report from advocacy group Public Citizen. In all, 10,672 physicians were listed in the National Practitioner Data Bank as having restricted or revoked clinical privileges, yet 5,887 (55%) of them did not see any licensing action from their states, the group reported. Of those escaping licensing actions, 1,119 had been otherwise disciplined for incompetence, negligence, or malpractice, and 605 were disciplined for substandard care, the report said. Hospital boards had identified 220 of the otherwise-unsanctioned doctors as “an immediate threat to health or safety,” according to Public Citizen.