In a world where we have come to rely upon the plentiful supply of low-cost, high-quality generic drugs, shortages and quality problems throw a definite kink into the goal of delivering needed medications to US patients. Supply shortages stem from a variety of factors, some of which are related to stepped-up manufacturing quality audits by the FDA, the ferocity of competition between generic manufacturers with associated recent company consolidations, and increasing demand, in general. In some cases, the brand manufacturer which innovated the drug has found it is no longer commercially feasible to produce and market the brand version of the drug. Thus, without sufficient generic options available, providers are stuck with no supply or sometimes seeking importation from outside the US (if approved by the FDA) where unknown manufacturing quality problems could also be a factor of concern. Sometimes the patient can be converted to an alternate (but not equivalent) drug; sometimes the needed but unavailable drug does not have a suitable substitute.
The linked article by Wall Street Journal reporter Jennifer Corbett Dooren (see: http://online.wsj.com/article/SB10001424052748704680604576110613604195324.html )
mentions recent critical shortages of generic injectable cancer drugs and indicates that hospitals are struggling to manage their supplies. These products may have very complex manufacturing processes which also lengthens the time it takes for other companies to flex and meet supply shortages; in order to be approved as a producer, a manufacturer needs FDA approval to jump in to fill the gap, which also adds time and challenge to the equation.
The number of reported drug shortages has more than tripled in the last five years, according to the FDA. And a spokesman for the American Society of Health System Pharmacists has labeled this a “near-crisis” situation.
Unfortunately, some of these supply problems are the direct consequence of consolidations and regulations which have made it harder to manufacture and compete for both branded and generic companies. Some Congressional leaders, not surprisingly, think that more regulations and penalties may improve the situation. In fact, they add to the burden and may actually make it harder to meet the demand.
Lest you think this is just another hysterical sound bite in the news, please note that the FDA has a link that you can regularly follow to identify these shortfalls. “The drug shortage program, within the Center for Drug Evaluation and Research (CDER), addresses potential or actual shortages of prescription, over-the-counter, or generic drugs that have a significant impact on public health.” The link takes a while to refresh so give the page a few seconds to be visible; it details for each short supply product the Drug Name, Company, Reason for Shortage, and Related Information guiding the reader through the details.
The solution, I believe, lays in developing policies that encourage generic companies to prosper and thrive so that there is sufficient opportunity to manufacture and market these products in a quality way.
Terri currently works for a large health sciences firm serving payers, pharmaceutical and device manufacturers and other stakeholders in health care as a Senior Principal in Managed Markets. The thoughts put forth on these postings are not necessarily reflective of the views of her employer nor other Health Thought Leader colleagues. Terri has had a varied career in health related settings including: 9 years in a clinical hospital pharmacy setting, 3 years as a pharmaceutical sales rep serving government, wholesaler, managed markets and traditional physician sales, 3 years working for the executive team of an integrated health system working with physician practices, 4 years as the director of pharmacy for a large BCBS plan, 12 years experience as founder and primary servant of a health technology company which was sold to her current employer three years ago. She has both a BS and a PharmD in Pharmacy and an MBA.
