Injunction Puts the Brakes on CMS Medicaid
Alexandria, VA -- A judge for the U.S. District Court for the District of Columbia granted an injunction on a preliminary motion filed by the National Association of Community Pharmacists (NCPA) and the National Association of Chain Drug Stores (NACDS). The decision effectively applied the brakes to the Center for Medicare and Medicaid Service's (CMS) proposed Medicaid pharmacy reimbursement reductions that were scheduled to go into effect this month. According to the ruling, CMS is not permitted to post data on the Internet related to the average manufacturer price (AMP) of generic pharmaceuticals nor will any reimbursement cuts take place before Judge Royce Lamberth has a chance to fully review the merits of the lawsuit.
Abraxis BioScience, Inc. Separates Its Business Units
Los Angeles, CA -- Abraxis BioScience separated its proprietary businesses (comprised of Abraxis Oncology and Abraxis Research) from its hospital-based business, Abraxis Pharmaceutical Products, thus creating two new publicly traded companies. Abraxis Pharmaceutical Products is now APP Pharmaceuticals (APP). According to a company spokesperson, the split was necessary so that each company can "deliver on their strategic visions and compete more effectively in their specialized marketplaces." APP specializes in manufacturing a broad base of injectable pharmaceuticals covering a variety of therapeutic categories including anti-infectives, oncolytics, anesthetics/analgesics, and critical care.
Novartis to Cut 2,500 Jobs over Next Two Years
Basel, Switzerland -- Novartis AG announced that it would eliminate 2.5% of its workforce over the next two years, citing product delays and generic competition. According to company sources, the cuts represent approximately 2,500 jobs and will realize an annual savings of $1.6 billion. CEO Daniel Vasella said the cutbacks were necessary to "simplify our organization and redesign the way we operate."
Phenylephrine Is an Oldie, and Maybe a Goodie
Washington, DC -- Phenylephrine, a decongestant that has been widely used for more than 65 years, may be getting a closer look by the FDA. The turn of events came about when many manufacturers of OTC combination cough and cold remedies switched from using pseudoephedrine to phenylephrine when it was it was discovered that the former drug was being used to make methamphetamine. Many critics of phenylephrine said that while the drug had a good safety record, they thought it was not as an effective decongestant as pseudoephedrine. Products from those manufacturers who chose not to change their OTC pseudoephedrine formulations must now be sold from behind the prescription counter. The Wall Street Journal reports that three professors from the University of Florida feel the drug's ineffectiveness may be related to its current 10-mg dose and has asked the FDA to review study data at a higher dose of 25-mg dose. They also urged the FDA to consider better-designed studies of the currently available 10-mg dose.
Mevacor Should Remain Prescription Only
Silver Spring, MD -- The FDA has been advised by an outside advisory panel not to allow Merck's statin, Mevacor, to be sold without a prescription. The 10-2 vote against selling the drug as an OTC product was prompted by a fear that patients may not understand how to use it properly. The move not to make the cholesterol-lowering drug over the counter was also supported by the American Medical Association. A spokesperson for the AMA said it was concerned that patients who do not take the drug properly might experience serious side effects.
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