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Important pharmacy news and late-breaking industry information updated daily.
FDA on Thursday withdrew a proposal that would have opened up generic companies to possible product-liability lawsuits over drug safety. The agency had proposed a new federal rule in 2013 that would have allowed people to hold generic-drug companies legally liable for the side effects of medicines.
Progress in reducing exposure to secondhand smoke among U.S. nonsmokers has stalled in recent years, despite longstanding declines over the past 30 years.
HHS on Thursday announced it will implement the long-delayed final rule for enforcing 340B drug ceiling price transparency on January 1, 2019. Enforcement will be maintained through a closed website available to 340B participating hospitals and providers. Federal regulators will post drug pricing information on the site.
To the relief of patient advocates, the U.S. Preventive Services Task Force is recommending that physicians be encouraged to offer an HIV prophylaxis to individuals at high risk for contracting the virus. PrEP, as the therapy is known, received regulatory approval for treatment of HIV in 2004 and was indicated for prevention 8 years later.
FDA Commissioner Scott Gottlieb proposed Thursday having all flavored electronic nicotine delivery systems—excluding tobacco, mint, and menthol flavors—sold in age-restricted, in-person locations and with increased age verification practices for online sales.
FDA approved this week epinephrine inhalation aerosol bronchodilator suspension (Primatene Mist—Amphastar Pharmaceuticals) for "temporary relief for symptoms of mild, intermittent asthma." The OTC metered-dose inhaler uses hydrofluoroalkane propellants, which are permitted under current international and U.S. law.
Some test strips used with at-home or in-the-office medical devices to monitor levels of warfarin may provide inaccurate results and should note be relied upon to adjust the drug dosage, FDA warned Thursday. Roche Diagnostics has initiated a voluntary recall of certain test strip lots used with its CoaguChek test meters.
President Trump on Thursday offered a plan to drive down the price Medicare pays for some prescription drugs, a move that could save taxpayers billions of dollars but also faces resistance from the pharmaceutical industry.