Regulatory and Washington

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.

ALEXANDRIA, Va. — The House of Representatives on Thursday passed the bipartisan Small Business Paperwork Mandate Elimination Act of 2011, which repeals the tax-reporting requirement for small businesses included in the healthcare law.

The legislation, introduced by Rep. Dan Lungren, R-Calif., passed in a 314-to-112 vote. The provision, which was part of the Patient Protection and Affordable Care Act , would increase 1099 tax reporting requirements for businesses that purchase goods and services of more than $600.

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

SILVER SPRING, Md. — The Food and Drug Administration is warning that long-term use of a class of drugs for gastroesophageal reflux disease may decrease levels of magnesium in the body and increase the risk of such side effects as seizures and heart rhythm problems, according to published reports.

The reports quoted the FDA as saying that in a quarter of cases of proton-pump inhibitors depleting magnesium from the body, use of magnesium supplements did not bring levels back to normal, and use of the drugs had to be stopped.