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Regulatory and Washington

  • FDA issues draft guidance on biosimilar interchangeability

    SILVER SPRING, Md. — The Food and Drug Administration recently shared the first draft guidance addressing the interchangeability of biosimilar drugs and their reference products. 
     
  • Affordable Care Act dealt second blow

    WASHINGTON, D.C. — The U.S. House of Representatives on Friday followed its U.S. Senate counterparts a week earlier, passing a budget resolution to draft a repeal bill that could overhaul or repeal the Affordable Care Act, otherwise known as Obamacare.

    “This is a critical first step toward delivering relief to Americans who are struggling under this law,” Speaker Paul D. Ryan (R-Wis.) said.

  • CDC report underscores value provider status legislation would hold for rural America

    ATLANTA — In what may be a serendipitous turn of events, on the same day the Senate re-introduced provider status legislation, the Centers for Disease Control and Prevention issued a report outlining the disparities between medically underserved communities in rural areas vs. their urban center counterparts.

  • Industry considers swift return of provider status legislation positive momentum

    ARLINGTON, Va. – Provider status is back on the Congressional menu as the Pharmacy and Medically Underserved Areas Enhancement Act (S. 109) was reintroduced Thursday with the bipartisan original co-sponsorship of more than one-quarter of the U.S. Senate. The return of that critical piece of legislation in the U.S. House of Representatives also is anticipated shortly.

    Could this be the year?

  • NCPA suggests any changes to ACA maintain Rx coverage and pharmacy access

    ALEXANDRIA, Va. – The National Community Pharmacists Association on Wednesday reached out to Republican congressional leaders to provide the community pharmacist perspective on repeal and replacement of the Affordable Care Act and potential Medicaid changes, the association stated.

  • GNC, Walmart founding members of Supplement Safety and Compliance Initiative

    WASHINGTON, D.C. – The Natural Products Association on Wednesday formed the Supplement Safety and Compliance Initiative, bringing together some of the largest retailers of natural products and supplements, including GNC and Walmart, on self-regulating the sale of VMS products.

  • Flu incidence on the rise and this season could be severe, CDC says

    ATLANTA  — Incidence of influenza is elevated in all but one of 10 HHS Surveillance Regions for the week ended Dec. 31, the Centers for Disease Control and Prevention recently reported. The end of the year marked the third week influenza activity was above the national baseline level of 2.2% as activity levels continue to climb.

    There were several pockets of high influenza activity, including throughout New York City, Puerto Rico and 10 states  (Alabama, Georgia, Louisiana, Missouri, New Jersey, New York, Oklahoma, Oregon, South Carolina and Utah).

  • CHPA, industry supports 'Restoring Access to Medication Act'

    WASHINGTON — The Consumer Healthcare Products Association on Wednesday applauded the introduction of bipartisan, bicameral legislation in the U.S. Congress that would restore the ability of consumers to use their tax-preferred flexible spending arrangements and health savings accounts to purchase over-the-counter medicines. The legislation, “Restoring Access to Medication Act (RAMA) of 2017” (H.R. 394 and S. 85), was introduced in the Senate by Sens. Pat Roberts, R-Kan., and Heidi Heitkamp, D-N.D., and in the U.S. House by Reps.

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