Author Archives: Jill Wechsler

PCORI Initiatives May Support More Drug Comparisons

The Patient-Centered Outcomes Research Institute (PCORI) is launching new programs that are expected to encourage more analysis of the effectiveness of specific drugs and medical products, while also building infrastructure that could support clinical research on biopharmaceutical products. Since it was established by the 2010 health reform legislation, PCORI has  devoted much of its resources […]
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FDA Guidances, OIG Investigations to Shape Drug Marketing, Research

Marketers may see further advice from the Food and Drug Administration in the coming year that clarifies how they can use social media. Priority topics:  presenting risk and benefit information in limited space; correcting independent/third party misinformation about a drug or medical device; and appropriate use of links, according to the agenda for the Center […]
Posted in Advertising, Biotech, E-Media, FDA, Legal, pricing, Regulatory, social media | Tagged , , , , , , , | Leave a comment

Waxman Retirement, Tip of the Iceberg

The Washington health policy world is headed for a major shake-up next year, as more long-time leading legislators opt for retirement. The recent announcement that Rep. Henry Waxman (D-Calif) will leave marks the end of a 40-year career on Capitol Hill, highlighted by engineering enactment of legislation that established the generic drug industry, supported treatment […]
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FDA Extends Oversight of Large Compounders

Moving fast to bolster its authority over compounding pharmacies that operate as manufacturers of prescription drugs, FDA is urging “outsourcers” to register, seeking state support, and moving to issue more rules and guidance. The agency is pleased that 14 outsourcers registered through mid-January. The number is small, considering that an estimated 3000 compounding pharmacies make […]
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FDA Gets More Funding, IPAB Gets Less

After two years in budget limbo, Congress finally enacted federal spending legislation for fiscal year 2014 last week, just before the latest funding extension ran out. In this period of ever-tighter government outlays, the Food and Drug Administration did fairly well in gaining additional funds, along with user fee revenues that had been put on […]
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