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Regulatory and Washington

  • Report: Exclusivity period for biotech drugs may be reduced to seven years

    WASHINGTON — The Obama administration’s proposed budget for 2012 contains an item that could change the game for biosimilars, according to published reports.

    According to the reports, the administration would lower the 12-year data exclusivity period for biotech drugs mandated in the healthcare-reform law to seven years.

  • N.Y. Medicaid program redesign could save state millions

    WASHINGTON — The New York State Health Department has proposed a plan that could save the state’s Medicaid program $350 million through 2015.

    The proposal would redesign the program so that it acts more like Medicare and private insurers. According to the Pharmaceutical Care Management Association, a trade group for pharmacy benefit managers, the program currently uses fewer generic drugs and pays pharmacists twice what they get from private insurers and Medicare.

  • NACDS RxImpact Day 2011 takes aim at new lawmakers

    WASHINGTON — The National Association of Chain Drug Stores and its members from across the country once again are flocking to Capitol Hill for RxImpact Day, a groundbreaking, two-day event that enables pharmacists to meet with members of Congress to discuss the vital role of retail pharmacy within the U.S. healthcare system and its ability to help reduce annual healthcare costs.

  • HHS unveils National Vaccine Plan

    WASHINGTON — The Department of Health and Human Services on Wednesday unveiled a new National Vaccine Plan to enhance coordination of all aspects of federal vaccine and immunization activities with the goal to ensure that all Americans can gain access to vaccines.

    “Vaccines are a critical cornerstone of the public health system,” stated Howard Koh, assistant secretary for health for HHS. “The National Vaccine Plan articulates a vision that will ensure that the nation’s prevention strategies protect the public for the next decade and beyond.”

  • Mylan gets approval for generic version of Vfend

    PITTSBURGH — Mylan has launched a generic drug for fungal infections, the company said Tuesday.

    Mylan announced the launch, through subsidiary Mylan Pharmaceuticals, of voriconazole tablets in the 50-mg and 200-mg strengths. The drug is a triazole antifungal agent.

    The tablets are a generic version of Pfizer’s Vfend, which had sales of $186 million in 2010, according to IMS Health. Mylan launched its version of the drug under a settlement with Pfizer.

  • NACDS: Pharmacy services provide effective, bipartisan solutions

    ALEXANDRIA, Va. — Upon the unveiling of President Obama's budget proposal, National Association of Chain Drug Stores president and CEO Steve Anderson said the budget proposal serves as yet another opportunity to highlight the "important role of pharmacy services as a bipartisan solution to an ongoing challenge: reducing healthcare costs while improving people's lives, particularly in the treatment of chronic conditions."

  • PCMA leader: Generics, mail-order pharmacy help save money

    WASHINGTON — Mark Merritt, the president and CEO of the Pharmaceutical Care Management Association, responded to a provision on the Pentagon's new budget proposal, which encourages Tricare members to use generic medications and mail-service pharmacies to save money.

  • NAD recommends modification of Clearblue Easy Digital ad claims

    NEW YORK — The National Advertising Division of the Council of Better Business Bureaus last week recommended that SPD Swiss Precision Diagnostics, manufacturer of the Clearblue Easy Digital home pregnancy test, modify its advertising to clarify to consumers that the test only delivers completely “certain” results on or after the day of a consumer’s expected menstrual period.

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