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  • Regulatory NewsRegulatory News

    Pelosi Drug Pricing Bill Advances on Party-Line Votes

    Two House committees on Thursday advanced on party-line votes Speaker Nancy Pelosi’s (D-CA) bill to allow for the negotiation of certain medicine prices as part of plans to bring down costs in the US. No major amendments were adopted in either the Energy & Commerce or the Education & Labor committees’ meetings, although the amendments in the E&C meeting ranged from carving out specific disease treatments from negotiations to requiring the Health and Human Services Sec...
  • Regulatory NewsRegulatory News

    Republicans Rebuke Pelosi Drug Pricing Bill

    United behind the pharmaceutical industry’s criticism of a wide-ranging drug pricing bill from House Speaker Nancy Pelosi (D-CA), Republicans on the subcommittee on health of the House Committee on Energy & Commerce on Wednesday criticized the bill at length and referred to the negotiation provisions as price controls. Chairwoman Anna Eshoo (D-CA), however, countered that the bill, known as HR 3 , includes many provisions that President Donald Trump and other Republica...
  • Regulatory NewsRegulatory News

    Product Hopping: E&C Hearing Addresses Restrictions to Generic Competition

    A subcommittee of the House Energy & Commerce Committee held a hearing on Thursday raising questions around some of the tactics pharmaceutical companies use to block competition, including the controversial use of product hopping. Product hopping, which involves companies reformulating drugs to restrict competition, can include many different types of reformulations, such as a change from a capsule to a tablet, a change in dosing or strength or a reformulation to an ext...
  • Regulatory NewsRegulatory News

    As Stem Cell Clinics Proliferate, E&C Leaders Seek to Hear FDA’s Plan

    A bipartisan group of representatives on the Energy & Commerce (E&C) committee sent a letter to US Food and Drug Administration (FDA) Acting Commissioner Ned Sharpless on Thursday seeking more details on the agency’s plan to slow the proliferation of stem cell clinics. While noting that FDA has agreed to exercise enforcement discretion for 36 months in a recent guidance, the letter also explains how CBER Director Peter Marks said in April that industry has shown “mo...