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Regulatory and Washington

  • FDA approves first drug for insomnia with middle-of-night waking, difficulty returning to sleep

    SILVER SPRING, Md. — The Food and Drug Administration has approved the first drug for insomnia in which patients wake in the middle of the night and have trouble returning to sleep.

  • Report: Merck KGaA alleges that Merck took over its Facebook page

    NEW YORK — Facebook wars happen all the time, but it's not often that drug manufacturers duke it out online.

  • Pfizer to sell Lipitor directly by mail

    NEW YORK — Pfizer is looking to sell its top-selling cholesterol drug directly to consumers at a greatly reduced price after the patent expires, according to published reports.

    The Wall Street Journal reported that Pfizer would partner with health plans to sell Lipitor (atorvastatin) directly to consumers through the mail when the drug's patent expires at the end of the month, opening the drug to generic competition.

  • Provider groups file lawsuit to battle Medi-Cal reimbursement rate cuts

    SACRAMENTO, Calif. — The recent approval of a 10% reimbursement rate cut in California’s Medicaid program, known as Medi-Cal, by the Centers for Medicare and Medicaid Services has prompted provider groups to file a lawsuit against the California Department of Healthcare Services and the U.S. Department of Health and Human Services, alleging that the cuts did not follow proper legal channels.

  • Mylan granted license to market generic menopause drug

    PITTSBURGH — Mylan will begin selling a generic drug for treating symptoms of menopause in two years, the company said Monday.

    Following the settlement of a patent-litigation suit with Swiss drug maker Novartis over the patch Vivelle-Dot (estradiol transdermal system), Mylan said it had received a patent license to begin selling its version of the drug in December 2013.

  • CRN adds food and drug law policy expert to staff

    WASHINGTON — The Council for Responsible Nutrition on Monday announced that Rend Al-Mondhiry has joined CRN’s staff to serve as the trade association’s regulatory counsel.

    “This is a new position for our association and [Al-Mondhiry's] skill set and experience provide a perfect match for what we need," CRN president and CEO Steve Mister said. "Her knowledge of food and drug law will make her a tremendous asset for our staff and for our members."

  • FDA approves Eylea

    SILVER SPRING, Md. — After being unanimously recommended for approval by a Food and Drug Administration panel, the FDA has approved an eye disorder treatment created by Regeneron Pharmaceuticals.

  • NCPA expresses concerns over restricted-network plans

    ALEXANDRIA, Va. — Many so-called restricted-network Medicare Part D prescription drug plans don't give adequate pharmacy access to rural residents and are deceptively marketed to patients, the National Community Pharmacists Association said Monday.

    The plans include those offered by a number of national retail chains and health insurers.

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