Monday, August 11, 2014

Question of the Day August 11, 2014 If a compounding phamacy is marketing to bring more patients in on the human size how is this reconciled with the medically necessity and patient-specific requirements?


1 comment:

Anonymous said...

A very good question. The advertising restrictions found unconstitutional by the US SC were nevertheless logical! Given the point you raise--marketing specific compounded products across a population is incongruent with compounding to meet the needs of an individual who is unable to take an FDA-approved product for medical reasons.
Because the U.S. public generally assumes that "marketed" prescrition products are FDA-approved and thoroughly vetted BEFORE coming to market, they are not "on notice" that the drug's safety and effectiveness have not been established.
The public (and the healthcare professionals they rely on) are called to fill in for FDA for making benefit-risk decisions around the prescribing, administration or use of compounded drugs and the promotional material they are bombarded with, however, they may not fully appreciate what material information should be included in their decision-making differential.
What is the number of compounded prescriptions a pharmacy (or their sales staff) would need to solicit to net one compelling need for a non-FDA approved product (i.e. find the true medically necessary, traditional compounding market space nested within the easily persuaded market space)? This question may touch on the reason why it made sense to include advertising restrictions in the original FDAMA…and why the market exploded after the restrictions were severed.