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Regulatory and Washington

  • CHPA names two directors for regulatory, scientific affairs

    WASHINGTON — The Consumer Healthcare Products Association has selected John Punzi and Jay Sirois to serve as directors of the organization's regulatory and scientific affairs department.

  • PCMA launches advertising campaign

    WASHINGTON — The main lobby representing pharmacy benefit managers is launching an advertising campaign amid scrutiny the industry has received lately from the public and lawmakers.

    The Pharmaceutical Care Management Association announced Tuesday the launch of its new "That's What PBMs Do" ad campaign, which includes print and video ads that focus on what the PCMA called PBMs' role in reducing pharmacy costs, Medicare Part D and mail-order pharmacy.

  • FDA submits recommendations for Generic Drug User Fee Act

    WASHINGTON — The Food and Drug Administration has finished and sent to Congress its recommendations for a proposed Generic Drug User Fee Act, drawing praise from the generic drug industry.

    GDUFA calls for the generic industry to pay $299 million per year for five years, in addition to what Congress gives the FDA. The money would come in the form of user fees for companies that submit regulatory approval applications to the agency for review.

  • FDA issues alert about sharing of insulin pens

    SILVER SPRING, Md. — The Food and Drug Administration's latest message to consumers and healthcare professionals seems like a no-brainer: "Insulin pens are not for sharing."

    But the agency said it knew of two undisclosed hospitals that it said had reused the cartridge components of insulin pens in administering insulin to more than 2,000 patients, though the hospitals reportedly changed the pens themselves.

  • Workable solution to meth epidemic right under authorities' noses

    WHAT IT MEANS AND WHY IT'S IMPORTANT — That one of the latest attempts to require prescriptions for cough-cold remedies containing pseudoephedrine appears headed for failure isn't just good news for the retailers that sell those products and the people who need them, it also may encourage those trying to curb the manufacture and use of methamphetamine to focus their efforts on methods that already work, such as the National Precursor Log Exchange, also known as NPLEx, a real-time, industry-funded electronic system that tracks sales of PSE products and is

  • California Senate committee tables PSE Rx-only bill

    SACRAMENTO, Calif. — The California State Senate Health Committee on Wednesday tabled a bill that would require a prescription for the purchase of a pseudoephedrine product, exempting children's liquid formulations.

    The bill initially failed to pass the committee by a vote of 2-2 with five no-votes. Subsequently, the committee placed the bill up for reconsideration by a vote of 7-0 with two no-votes. No subsequent hearing date has been posted the Senate's website.

  • December retail sales reach $400 billion mark

    WASHINGTON — Despite barely rising in December, retail sales hit a record for the year, according to figures released by the U.S. Census Bureau on Thursday.

    U.S. retail and food services sales for the month, adjusted for seasonal variation and holiday and trading-day differences, but not for price changes, increased 0.1% to $400.6 billion from the previous month and 6.5% above December 2010. Adjusted retail sales were virtually unchanged.

  • FTC ends investigation of CVS Caremark

    WOONSOCKET, R.I. — CVS Caremark announced on Thursday that the Federal Trade Commission has concluded its investigation into the company’s business practices.

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