Regulatory and Washington

DARMSTADT, Germany — The Food and Drug Administration declined to approve a Merck KGaA drug designed to treat relapsing-remitting multiple sclerosis.

ALEXANDRIA, Va. — The National Association of Chain Drug Stores and the National Community Pharmacists Association have expressed their support for H.R. 891, the Medication Therapy Management Benefits Act of 2011, as it would expand the pool of Medicare Part D beneficiaries who can qualify for the service provided by a licensed pharmacist to any patient with a chronic medical condition. Currently, only those patients suffering from multiple chronic conditions are eligible.

Reps. Cathy McMorris Rodgers, R-Wash., and Mike Ross, D-Ark., introduced the bill.

ALEXANDRI, Va. — In a letter penned Thursday by the National Association of Chain Drug Stores to Sen. Olympia Snowe, R-Maine, the association stated that while it shares the goal of reducing prescription drug costs, authorizing the reimportation of prescription medications — as sought in S.319, the Pharmaceutical Market Access and Drug Safety Act of 2011 — raises concerns about patient health and safety.

BRIDGEWATER, N.J. — The Food and Drug Administration has approved a generic drug for pain and inflammatory diseases made by Amneal Pharmaceuticals, Amneal said Thursday.

The FDA approved indomethacin extended-release capsules in the 75-mg strength. The drug is used to treat pain associated with rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, bursitis and tendonitis.

WASHINGTON — The National Retail Federation warned federal transportation officials that transportation costs would increase by up to 20% in some cases if a proposal to limit the number of hours truck drivers spend behind the wheel each day goes into effect.

In addition to dramatically increasing costs, the safety proposal also would make highways a little less safe for the general public by putting more trucks on the road during the most congested hours, the NRF argued.

CHADDS FORD, Pa. — Endo Pharmaceuticals has launched a recently approved testosterone gel for men.

Endo announced Thursday the launch of Fortesta, approved by the Food and Drug Administration for treating low testosterone — or low T — in men, which affects about 14 million men in the United States; around 1.3 million of those men currently are receiving treatment, according to Endo.

PASADENA, Calif. — Long-term use of a class of drugs used to control pain could increase the risk of erectile dysfunction in men, according to a new study.

The study, sponsored by Kaiser Permanente and published online in the Journal of Urology, found that men who took nonsteroidal anti-inflammatory drugs, or NSAIDs, three times a day for more than three months were 2.4 times as likely to have erectile dysfunction as men who didn’t take the drugs regularly. The study used data from 80,966 men ages 45 to 69 years in California.

SILVER SPRING, Md. — The Food and Drug Administration has taken action against makers of prescription drugs for cough-cold and allergies that don’t have regulatory approval, the agency said Wednesday.

The action is part of the agency’s Unapproved Drugs Initiative, which seeks to remove from the market drugs that have not received approval. In many cases, the drugs were marketed before the FDA adopted its current regulatory standards.