Pfizer Beats Lipitor Challenges
The U.S. Supreme Court has declined to take action on Ranbaxy Laboratories Ltd.'s appeal of a lower court ruling that upheld Pfizer's patent for Lipitor (atorvastatin). The U.S. District Court for the District of Delaware ruled in late 2005 that Lipitor's two patents—due to expire in 2010 and 2011—were valid, and that Ranbaxy's marketing a generic before 2011, as planned, would constitute infringement. Ranbaxy's appeal of the ruling was declined by the Supreme Court in early April. As a result, Lipitor—the world's top-selling drug, with sales of about $13 billion in 2006—is protected from generic competition until 2011. Pfizer also recently sued Ranbaxy, India's largest drug company, to block its efforts to sell a generic version of Caduet (amlodipine/atorvastatin). Finally, Pfizer has won an injunction against sales of Ranbaxy's generic Lipitor in Denmark.
FDA Posts Postapproval Study Data
All postmarketing studies of medical devices ordered by the Food and Drug Administration since January 2005 are now listed on an FDA Web site, the agency reported. The site gives the manufacturer's name and the name of the product being studied, and includes a short description of the trial. It also shows whether a company is submitting required updates to the FDA, but it does not reveal any data, such as interim findings. “Electronic access will give the public an opportunity to see progress being made on a company's postmarket commitments,” said Dr. Daniel Schultz, director of the agency's Center for Devices and Radiological Health, in a statement. The data site is
Skirting Self-Referral on Imaging
A study published online in the journal Health Affairs said that many physicians are finding ways to skirt a Medicare law—known as Stark II—that prohibits most referrals to facilities in which they have an ownership interest. Using data from a large California-based insurer, Jean Mitchell, a professor of public policy at Georgetown University, found that 33% of providers who billed for magnetic resonance imaging (MRI), 22% who billed for computed tomography (CT), and 17% of those who billed for positron emission tomography (PET) were technically self-referring. A majority—61% of MRI billers and 64% of CT billers—did not own the equipment but had lease or payment-per-scan arrangements that would violate federal and state antikickback statutes, said Ms. Mitchell.
ACC Update on Stents for Patients
The American College of Cardiology has published a one-page patient information update on stents. The page notes that only a patient and a physician can decide if a stent is necessary and appropriate for that particular patient. It goes on to outline several points patients should keep in mind, including that stents do not cure coronary artery disease, that all stents reduce symptoms of heart disease, that coated stents are more effective in preventing recurrent blockage, and that it is important to follow a cardiologist's recommendations on taking anticlotting agents such as aspirin, clopidogrel, and ticlopidine. The update can be found on ACC's Web site,
Angiomax Patent Relief?
The Medicines Co. is seeking congressional intervention again to extend the patent on its anticoagulant Angiomax (bivalirudin), due to expire in 2010. The company missed the deadline for filing a 5-year extension application by 1 day in 2000, and has been seeking to have it rectified since, primarily through the U.S. Patent Office. However, last month, Rep. Duncan Delahunt (D-Mass.) reintroduced a bill to allow the Patent Office to accept unintentionally late filings.
CMS Softens NPI Stance
Physicians and other health care providers who fail to comply with the May 23 deadline to acquire and start using National Provider Identifiers will not be penalized if they can show they deployed a “contingency plan,” the Centers for Medicare and Medicaid Services announced. “Covered entities that have been making a good faith effort to comply with the NPI provisions may, for up to 12 months, implement contingency plans that could include accepting legacy provider numbers on HIPAA transactions in order to maintain operations and cash flows,” said CMS Acting Administrator Leslie Norwalk in a statement. The agency decided to create this grace period “after it became apparent that many covered entities would not be able to fully comply with the NPI standard” by the original deadline, Ms. Norwalk said. The new compliance guideline can be downloaded from the agency's Web site (
1 in 3 Physicians Now Female
A major demographic shift is underway in medicine as female physicians become more numerous, and this trend will influence the way medical groups recruit and retain physicians throughout their career cycles, according to the 2006 Retention Survey from the American Medical Group Association and Cejka Search, an executive search organization. In 2006, female physicians accounted for 35% of physicians employed in the medical groups responding to the survey, compared with 28% in the previous survey. The study revealed that factors such as “poor cultural fit” and family issues are the driving forces in physician turnover. Part-time and flexible work options also are growing in importance, the survey found.