Bristol-Myers Squibb Fined
Bristol-Myers Squibb Co. will pay $2.1 million—the largest fine allowed by law—for failing to report an agreement it reached with Apotex Inc. on generic competition for its blockbuster cardiovascular drug Plavix (clopidogrel), the Federal Trade Commission said. Bristol-Myers Squibb didn't disclose that in 2006 the two companies made a deal to schedule the releases of their generic versions of the drug to reduce competition, according to the FTC. The agency said that failing to disclose the oral agreement violated both a 2003 FTC order and the Medicare Modernization Act, which requires that certain drug company agreements be accurately reported to both the FTC and the U.S. Department of Justice. In 2007, Bristol-Myers Squibb paid $1 million to settle a criminal complaint that the company had lied about the Plavix agreement with Apotex. The name-brand manufacturer has also settled several state actions arising from the generic-timing agreement, the FTC said.
Massachusetts Clinics Are Busy
Community health centers in Massachusetts saw a significant increase in their patient load from 2005 to 2007, as the state implemented its health reform law, according to a study from the Kaiser Family Foundation. The 34 federally qualified clinics, which provide comprehensive primary care for low-income and uninsured patients, served 482,503 patients in 2007, up more than 51,000 from 2 years earlier, the foundation reported. The state's reform aims at universal coverage, but many people remain uninsured. Although the number of health center patients lacking insurance declined, the clinics in 2007 cared for a much larger proportion (36%) of the state's uninsured population than before. The experience in Massachusetts shows that community health centers play a critical role in caring for newly insured patients while continuing to serve as the primary safety net for those who remain uninsured, the report concluded.
FDA Warns on Internet Ads
The Food and Drug Administration has warned 14 drug makers against using brief Internet ads to promote drugs, saying the ads are misleading because they fail to provide full information about risks and indications. The ads typically appear on search engines, such as Google, as “sponsored links” when patients search for information on medical conditions. The ads cited by the FDA include promotions for the multiple sclerosis drug Tysabri (natalizumab), the cardiovascular drug Plavix (clopidogrel), and the diabetes treatment Avandia (rosiglitazone). The sponsored links generally contain only a dozen or so words—not enough to convey detailed treatment or risk information, according to the FDA. The Pew Prescription Project, a nonprofit drug-safety group, has asked the FDA to articulate the rules regulating online advertising and to advise manufacturers on where risk disclosures may appear in Internet ads.
FDA Seeks Data on Older Devices
The FDA has ordered manufacturers of 25 class III medical devices that were approved before 1976 to submit safety and effectiveness data to the agency by Aug. 7. The devices include an intra-aortic balloon and its control system, a ventricular bypass assist device, generators, materials for pacemakers, automated external defibrillators, and some types of hip joints. The FDA will decide whether to require a full approval application or reclassify the device to a lower-risk regulatory category. The Advanced Medical Technology Association issued a statement saying it was pleased the process is moving forward, but emphasized that “the device types subject to the FDA notice have already been thoroughly reviewed by the agency,” based on technological and performance data or, in some cases, clinical data.
Issues of Drug Class Pending
Logistical and cost issues must be addressed before a behind-the-counter class of nonprescription drugs can be established officially in the United States, the Government Accountability Office said in a report on so-called BTC drugs. The GAO stressed that pharmacists must be ready to provide BTC counseling and that pharmacies must protect consumer privacy. Also, policy makers should address cost issues, such as availability of third-party coverage for BTC drugs and pharmacists' compensation for providing associated services. GAO researchers studied the experiences of five countries, including Italy and the Netherlands, that have a behind-the-counter or similarly restricted drug class.
EMR Applications Rise
As of the March 31 deadline, 64 companies had applied for certification of their electronic medical record (EMR) products, one-third more than had applied by the same time last year, the Certification Commission for Healthcare Information Technology reported. Nearly 40% of the applications were for new EMR products, rather than renewals, according to the federally recognized commission. Nearly two-thirds of the applicants qualified as small businesses, the commission noted. The biggest category, with 26 applications, was for EMR products for children. Other applications covered cardiovascular medicine, emergency departments, and inpatient records. So far, 25 of the products have been certified, the commission said.