Regulatory and Washington

WHAT IT MEANS AND WHY IT’S IMPORTANT — No matter how you slice it, the flexible spending account changes that are part of the overall Affordable Care Act aren’t doing a whole lot by way of saving healthcare dollars, at least not for patients. Indeed, about the only benefactors are those folks who have to make dollars and cents out of what might become the first casualty of the Obamacare healthcare package — those who have to explain how the administration plans to pay for this package, you know, by not raising taxes.

NEW YORK — Johnson & Johnson and the U.S. government are suing two generic drug makers to stop them from launching a generic drug for HIV, according to published reports.

Bloomberg reported Thursday that Tibotec, a subsidiary of J&J, and the government were separately suing Mylan and Lupin over a generic version of the drug Prezista (darunavir ethanolate), alleging patent infringement.

SILVER SPRING, Md. — The Food and Drug Administration on Friday reported that Vigor-25, a product inappropriately marketed as a natural dietary supplement to enhance male sexual performance, should not be purchased or used because it contains sildenafil, the active ingredient in the prescription drug Viagra.

WASHINGTON — A coalition of six associations, including the Consumer Healthcare Products Association and the National Association of Chain Drug Stores, on Thursday called on Congress to repeal the requirement that prevents consumers from using their flexible spending accounts to purchase over-the-counter medicines without a prescription as of Jan. 1.

WHITEHOUSE STATION, N.J. — A Food and Drug Administration advisory committee has recommended expanded approval of a vaccine for genital warts.

Merck announced Wednesday that the FDA Vaccines and Related Biological Products Advisory Committee recommended approval of Gardasil (human papillomavirus quadrivalent [types 6, 11, 16 and 18] vaccine, recombinant) for males and females ages 9 to 26 years to prevent anal cancer and anal intraepithelial neoplasia, both diseases that result from infection by the human papillomavirus.

SILVER SPRING, Md. — A class of alcoholic beverages that rapidly became popular among young people over the last few years is headed for the drain.

The Food and Drug Administration issued warning letters to four manufacturers of beverages that combine high amounts of alcohol and caffeine, effectively issuing a federal ban on the beverages.

SILVER SPRING, Md. — The Food and Drug Administration on Monday teamed up with the Centers for Disease Control and Prevention and other healthcare professionals, government, academic, international and industry partners to support Get Smart About Antibiotics Week, Nov. 15 to 21, as part of a joint effort to encourage the appropriate use of antibiotics.

ALEXANDRIA, Va. — The Centers for Medicare and Medicaid Services has proposed a rule shortening the traditional 30-day drug cycle for long-term care centers to seven days when brand-name drugs are dispensed, prompting a supportive response from an organization representing independent pharmacies.