Economic Superiority Claims, Manufacturer/Payer Relationships Ripe For Enforcement Scrutiny
The era of big pharma off-label promotion cases may be coming to a close, but federal prosecutors are eyeing other industry practices for enforcement, including unsupported promotional claims of economic superiority and superior efficacy, and manipulation of the average sales price system.
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“The Pink Sheet” – Most Notable Stories Of 2012
Developments in off-label enforcement and scrutiny of economic superiority claims, new approaches to R&D, and biosimilars are among issues that captured readers’ attention last year.
Health Economic Promotions To Formulary Managers: Seldom Used Or Under The Radar?
A review of FDA enforcement actions against drug marketing practices over the past 10 years finds no mention of specific violations of Sec. 114 of the FDA Modernization Act, which allows drug companies to take the initiative to disseminate health economic information to formulary managers in certain circumstances.
Drug Safety Communications Are Not Crisis Management Tools, FDA Says
A new draft guidance explains the Center for Drug Evaluation and Research’s approach to communicating emerging drug safety information. Since 2010, Drug Safety Communications have replaced a variety of audience-focused tools laid out in a 2007 guidance, but FDA says public health alerts will be used to communicate about products that pose an immediate danger.