Regulatory and Washington

MORRISTOWN, N.J. — Generic drug maker Watson Pharmaceuticals is hoping to become the first to market a version of a popular opioid painkiller.

Watson said it had filed applications with the Food and Drug Administration seeking approval for a generic version of Purdue Pharma’s OxyContin (oxycodone) extended-release tablets in the 10-, 15-, 20-, 30-, 40-, 60- and 80-mg strengths.

ROCKVILLE, Md. — The U.S. Pharmacopeial Convention last week announced that it is working with the Food and Drug Administration and the Consumer Healthcare Products Association to update quality standards for widely used medicines and ingredients. Updated test methodologies are crucial to help counter economically motivated adulteration — in which less expensive and potentially harmful ingredients are substituted for genuine medicines or their ingredients — and also to address the challenge of impurities that may go undetected with older, nonspecific assays and tests.

WASHINGTON — Ten states could reap significant savings by increasing the use of generic drugs in their state Medicaid programs, the Generic Pharmaceutical Association said Monday in response to a report by the American Enterprise Institute, a conservative think tank.

The report, “Overspending on Multi-Source Drugs in Medicaid,” by Alex Brill, identified states that overspend the most on their Medicaid programs, with California, Texas and Georgia topping the list.

ALEXANDRIA, Va. — Looking to further communicate the important role pharmacy plays in the healthcare delivery system, the National Association of Chain Drug Stores president and CEO Steve Anderson ran an opinion column in a "Medication Non-Adherence" supplement published Monday by Mediaplanet and distributed in The Washington Post.

SILVER SPRING, Md. — The Food and Drug Administration has approved a vaccine for shingles in older patients.

The agency said Thursday that it had approved Merck’s Zostavax (zoster vaccine live) vaccine in patients ages 50 to 59 years. The vaccine already is approved for those ages 60 years and older.

Shingles, caused by the varicella-zoster virus, the same virus that causes chickenpox, affects about 200,000 people in the United States ages 50 to 59 years each year.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new treatment for late-stage skin cancer, the agency said Friday.

The FDA approved Bristol-Myers Squibb’s Yervoy (ipilimumab) for patients with melanoma that has spread to other parts of the body, also known as metastasis. More than 68,000 new cases of melanoma were diagnosed in the United States in 2010, and about 8,700 died from it, according to the National Cancer Institute, part of the National Institutes of Health.

There are three issues involving over-the-counter medicines today that have put the industry on the defensive, and all involve the question of appropriate access. Drug Store News examined each.

1. FLEXIBLE SPENDING ACCOUNTS
The issue: The Patient Protection and Affordable Care Act required that FSA participants obtain a prescription for those OTCs incorporated into their health savings agenda.

NEW YORK — A group representing specialty pharmacies is calling on the Department of Defense to not use exclusive networks in the Tricare pharmacy program.

The Independent Specialty Pharmacy Coalition said exclusive arrangements for the program, also known as TPharm, were anti-competitive and harmful to patients who rely on specialty care by reducing patient choice and disrupting the continuum of care for them, and that reductions in pharmaceutical costs would not necessarily reduce overall healthcare spending.