Regulatory and Washington

WASHINGTON — One could say that a job with the Food and Drug Administration would be the perfect way to get information about upcoming drug approvals and use it to profit handsomely from buying stock in the companies that manufacture the drugs before the information reaches the public.

Of course, the Securities and Exchange Commission would consider that illegal insider trading, as one FDA scientist recently discovered.

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.

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.

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.

MORRISTOWN, N.J. — A generic painkiller made by Watson Pharmaceuticals infringes a patent covering the branded version, a U.S. District Court ruled.

Watson said Friday that the U.S. District Court for the District of Delaware decided that Watson’s generic version of Cephalon’s Fentora (fentanyl) buccal tablets infringes U.S. Patent No. 6,264,981, though the Food and Drug Administration had approved Watson’s version of the drug.

ALEXANDRIA, Va. — A group representing the nation's community pharmacies has applauded legislation introduced in Mississippi that will increase oversight over pharmacy benefit managers.

The National Community Pharmacists Association lauded Mississippi S.B. 2445 and expressed its support of the bill in a letter to state legislators. The bill, NCPA EVP and CEO Kathleen Jaeger said, "would end the special treatment for out-of-state, mail-order pharmacies and put local Mississippi pharmacists first."