Category Archives: compliance
By Jill Wechsler | Published: December 12, 2012
If people can promote drugs for uses that lack supporting evidence, it would turn back the clock to the pre-1962 world of medicine where there wasn’t any research or data on what medicines worked and what was harmful, says Robert Temple, deputy director for clinical science at FDA’s Center for Drug Evaluation and Research (CDER).
By Ben Comer | Published: December 5, 2012
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?
By Clark Herman | Published: November 16, 2012
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 [...]
By Clark Herman | Published: November 14, 2012
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 [...]
By Ben Comer | Published: November 7, 2012
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.