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Regulatory and Washington

  • FDA: Certain TNF blockers could be linked to rare cancer

    SILVER SPRING, Md. — The Food and Drug Administration has received reports of a rare and usually deadly cancer in patients using a class of biotech drugs to treat autoimmune and inflammatory diseases, the agency said Thursday.

  • Georgia seeks to restrict PSE product sales to pharmacies

    ATLANTA — A bill passed by the Georgia House of Representatives Tuesday will restrict the sale of products containing pseudoephedrine to only pharmacies — a factor that will eliminate PSE products for sale at any gas stations, convenience stores and mass merchants/supermarkets without a pharmacy.

    PSE, however, still  will be available without a prescription. The bill is headed to the governor's office for signing.

  • NCPA backs bill to enhance pharmacy competition

    ALEXANDRIA, Va. — The National Community Pharmacists Association on Wednesday announced support for the Quality Health Care Coalition Act of 2011 (H.R. 1409), which was introduced last week by House Judiciary Committee ranking member Rep. John Conyers Jr., D-Mich., and Rep. Ron Paul, R-Texas, in an effort to improve the quality of patient care by leveling the playing field between healthcare professionals and insurance companies in the healthcare industry.

  • Diabetes stakeholders discuss how healthcare-reform law affects patients

    NEW YORK — Healthcare reform has remained a major subject of debate since President Barack Obama signed the Patient Protection and Affordable Care Act last March, but what the law means for diabetes care was the particular focus of a conference call with diabetes stakeholders Tuesday.

  • FDA advisory committee recommends approval for Pfizer's Sutent

    NEW YORK — A Food and Drug Administration expert panel has given a favorable vote to a drug made by Pfizer for tumors, Pfizer said Tuesday.

    The FDA’s Oncologic Drugs Advisory Committee voted 8-2 that Sutent’s (sunitinib malate) benefits outweigh its risks in the treatment of unresectable pancreatic neuroendocrine tumors.

    While the FDA is not bound by advisory committee votes, it takes them into consideration when deciding whether or not to approve a drug.

  • NACDS signs on for Partnership for Patients: Better Care, Lower Costs

    ALEXANDRIA, Va. — The National Association of Chain Drug Stores said that it has signed on as a partner for a new public-private partnership, announced by the Department of Health and Human Services and Centers for Medicare & Medicaid Services, that seeks to improve patient health and lower healthcare costs through the use of community-based care transition programs.

    NACDS lauded the initiative's recognition of pharmacy's role in helping patients take their medications as prescribed.

  • FDA accepts regulatory application for Bio-T-Gel

    LINCOLNSHIRE, Ill. — The Food and Drug Administration has accepted a regulatory approval application for a topical treatment for low testosterone made by Teva Pharmaceuticals and BioSante Pharmaceuticals, BioSante said Wednesday.

    The two companies said the FDA had accepted their application for Bio-T-Gel and expected to complete its review by mid-November.

  • Perrigo facility cleared by FDA

    ALLEGAN, Mich. — Perrigo on Tuesday announced that the Detroit office of the Food and Drug Administration has concluded its re-inspection of Perrigo's Allegan facility.

    The FDA has informed Perrigo that, effective immediately, Perrigo has an acceptable regulatory status, such that any pending export license and abbreviated new drug applications from this facility will once again be eligible for review and approval.

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