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  • Regulatory NewsRegulatory News

    New House Bill Seeks to Allow HHS to Negotiate Medicare Drug Prices

    Rep. Jan Schakowsky (D-IL) on Thursday introduced a new bill that would allow the Department of Health and Human Services (HHS) secretary to negotiate Medicare Part D prices for either sole-source drugs or biologics and are not manufactured by more than two drug companies. Under the bill, drug manufacturers and the secretary would have 90 days to negotiate the price of a drug covered by Medicare Part D. If the two parties fail to reach an agreement after the allotted tim...
  • Duo of US Bills Aim to Prevent Drug Shortages, Amend 510(k) Pathway

    Representatives John Carney (D-DE) and Ed Markey (D-MA) both introduced bills this week that would, respectively, aim to prevent drug shortages and grant the US Food and Drug Administration (FDA) the authority to prevent medical devices from claiming substantial equivalence to a recalled medical device. Carney's bill, the Drug Shortage Prevention Act of 2012 , would amend Chapter V of the Federal Food, Drug and Cosmetic Act ( FD&C Act ) to require FDA to establi...