With unemployment on the rise, so is the demand for prescription drug assistance from clinics all over the country. “There is no comparison to the demand we’re seeing that I can recall,” says Ken Trogdon, Welvista’s CEO. (Welvista is a Columbia, S.C.-based mail-order pharmacy that collects and supplies free medications from a dozen different pharmaceutical companies.) Like many other similar organizations, Welvista saw its patient-assistance applications nearly double in January. Luckily for these organizations, they have been able to keep up with demand due to an influx of additional samples being supplied by more and more physicians across the country. The Dispensary of Hope, a Nashville-based not-for-profit that supplies free prescription drugs to people with no coverage and low incomes, depends largely on physicians to send in surplus prescription samples from drug-industry reps that would otherwise soon expire.
With this new influx of inventory, and greater demand for the products, a large window for possible non-compliance has opened with it. With clinics handling more drugs then they ever have before, and having a greater need for a quick turnaround to meet the rising demand; clinics may not be equipped to properly meet all the regulatory requirements outlined by the FDA in 21 CFR 203.39 for drug sample donations. Currently, the FDA is in the process of revising the regulation as it pertains to free clinics, to relieve the clinics of some burdensome tasks they were previously required to perform. However, the FDA does provide a suggested guidance to the clinics, and reserves the right to exercise enforcement of the guidance at its own discretion. The “Guidance for Industry Prescription Drug Marketing Act — Donation of Prescription Drug Samples to Free Clinics,” specifically states that the:
FDA, in the exercise of its enforcement discretion, does not intend to object if
a free clinic fails to comply with § 203.39(b), (d), (e), (f), and
(g). For the most part, these subsections focus on recordkeeping
requirements. FDA does, however, expect free clinics to comply with §
203.39(a), (c), (h), and (i). For the most part, these subsections focus
on ensuring the integrity of samples stored and dispensed by clinics, and should
not be too onerous for free clinics to comply with and still operate
With this unprecedented flow of drugs in and out of the clinics, this will be a good test for the clinics and the FDA to see how strictly regulations will, or even can, be followed. This opens up some opportunities for CIS as well, to provide their services to look into these regulations and activities. To be able to provide recommendations and process improvements to ensure all parties involved are safe and happy.
1. As More Lose Jobs and Coverage, Free Drugs are a Booming Business; Posted by Vanessa Fuhrmans, February 19, 2009
2. Guidance for Industry Prescription Drug Marketing Act — Donation of Prescription Drug Samples to Free Clinics; U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), March 2006