Health Economic Promotions To Formulary Managers: Seldom Used Or Under The Radar?
Executive Summary
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.
You may also be interested in...
FDA Discussing Guidance On Giving Drug Economic Data To Formulary Managers
FDA official Tom Abrams recently acknowledged heightened stakeholder interest in guidance on appropriate communications of health care economic data under FDAMA Sec. 114.
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.
Copay Accumulators: Pending CMS Reg May Offer More Clarity After Judge Limits Scope
Programs only allowed for brands with generic competition under court ruling, but related programs such as copay maximizers and so-called ‘alternative funding’ programs are not directly impacted by the decision.