Legal News

With the shifting political landscape in Congress and state legislatures across the nation, and an increased focus on health care, 2009 could be a busy year for pharmacy initiatives, according to Geralyn M. Trujillo, MPP, the director of state government affairs for the American Society of Health-System Pharmacists (ASHP).

The Centers for Medicare and Medicaid Services recently informed Part D plans they are suspending the current collection of long-term care rebate reports for 2008 and 2009, in lieu of a new reporting requirement that will be changed in 2010. Additionally, the agency plans to test the proposed reporting requirements with a small number of Part D sponsors prior to 2010.

Pharmaceutical Research and Manufacturers of America (PhRMA) President and CEO Billy Tauzin today expressed his hope that the next head of the U.S. Food and Drug Administration can work with diverse constituents and improve the agency?s scientific bases.

A San Francisco judge denied Philip Morris' request for a temporary restraining order against the ban on pharmacy sales of tobacco products. The ban will affect 52 of 54 Walgreens as well as other chain pharmacies such as Rite-Aid and Longs.

The Joint Commission's anticoagulant safety goal goes into effect Jan. 1, 2009. Physicians, pharmacists, and nurses at health-care systems around the country are collaborating to improve best practices and to put more stringent measures in place.

The U.S. Food and Drug Administration is notifying health care professionals and patients that Tyco Healthcare Group LP (Covidien) is recalling one lot of ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles due to possible mislabeling. The use of these syringes may lead to patients receiving an overdose of as much as 2.5 times the intended dose, which may lead to hypoglycemia, serious health consequences, and even death.

Free clinics in West Virginia dispense more than 500,000 prescriptions a year. Earlier this year they came under regulation by the state pharmacy board. Defenders argue that the board is trying to fix something that isn't broken. The board says that patient safety requires oversight.

Criminals buy cold remedies for the pseudoephedrine, which they use to make methamphetamine. Kansas pharmacists are fighting back with MethShield, an electronic program that tracks sales and catches illegal purchasers in the act. It even calls the cops.

A pending Federal Trade Commission (FTC) report, expected later this year, may settle the decade-old dispute as to whether authorized generics are legal. With billions of dollars at stake, the loser will undoubtedly challenge the government's decision.

Congress continues to work to create a regulatory pathway for approval of generics for biopharmaceuticals (or biologics), but passage of such legislation seems unlikely this year with the presidential election rapidly approaching.