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Category Archives: compliance
US v. Caronia: What Constitutes 'Truthful' Speech?
If a drug’s label is not the final word on what is true – or untrue – about a product, then who decides what can and cannot be said during a sales detail?
Also posted in Advertising, FDA, Legal, Marketing, Regulatory, Safety, Sales, Strategy Tagged Alfred Caronia, Appeals Court, Detailing, DoJ, FDA, Federal Trade Commission, FTC, Jazz Pharmaceuticals, Marketing, off-label, Office of Prescription Drug Promotion, Orphan Medical, OTC, Professional Marketing, Promotion, Regulatory, sales rep, Sorrell v. IMS Health, US v. Caronia 1 Comment
Pharma Forecast 2020: Cold Comfort
Price Waterhouse Cooper’s “Pharma 2020: From vision to decision” parses a mix of gloomy and glowing scenarios that reflect the fickle, delicate nature of today’s industry. On the one hand, innovations in other areas such as mobile technology promise to breathe new life into pharma with cutting-edge initiatives. On the opposite end, stark fiscal realities [...]
Also posted in Emerging Markets, Europe, FDA, Global, IP, R&D, Regulatory, Strategy, pricing Leave a comment
Dissecting ACA's Section 6004: Tipping the Balance on Sampling Controls?
With the Affordable Care Act [ACA] officially settling into the US’ political landscape, a pressing – but little noticed – issue is the provisions for increased compliance on industry promotion practices. Of specific concern is Section 6004 of the ACA, which demands more rigorous reporting on the distribution of free samples to physicians from pharmaceutical [...]
Also posted in FDA, Manufacturing, Regulatory 1 Comment
Pharmacists: The Other White Coats
Patients in search of face time with a healthcare provider are stopping into their local drugstores, where consultations are free and the wait time is shorter. Pharmacists are in a unique position, too, to move the needle on drug adherence.
Temple 'Horrified' by Caronia Decision