Category Archives: compliance

Health Reform May Boost Illicit Drug Sales

Health plans that limit drug converge will encourage consumers to obtain medicines illegally, according to pharmacy experts. Marv Shepherd, director of the Center for Pharmacoeconomic Studies at the University of Texas College of Pharmacy and others noted at the Partnership for Safe Medicines Interchange in October in Washington that an increase in narrow health plan […]
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Putting a Price Tag on Compliance: Cheap Change or Big Bucks?

Compliance rules under the US Physician Payments Sunshine Act have been criticized for the excruciating level of detail demanded from individual company submissions.  But relatively little scrutiny has been accorded to another pressing question:  how much will all this new reporting cost?  The burden of compliance for not just this new law but in many […]
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Gov't Shutdown Halts FDA Product Submissions and Other Functions

Planning to submit to the FDA today? Think again. The agency put a forced pause on key services and functions – and furloughed 6,620 FDA employees – as a result of last night’s government shutdown. Stephen King, a member of CDER’s communications team at FDA, said in an email that “no new regulatory submissions that […]
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FTC Concerned About Increase in "Sponsored Content"

The blurring of advertising and editorial content, particularly through publishers’ websites and mobile applications, is in the spotlight at the Federal Trade Commission (FTC) as government regulators struggle to deal with the impact of social media on health-related promotion. The Commission’s long-held policy is that advertising and sales pitches should be readily identified and not […]
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The Sunshine Act Makes for Gloomy Sales Reps

On Café Pharma message boards, the drug industry’s online water cooler, anonymous sales reps are sounding off on the Physician Payment Sunshine Act and its implications for their battered profession. Here’s a selection from a thread that PharmExec came across, edited for spelling, punctuation, and coherence:
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