In an unfortunate twist, FDA is admonishing healthcare providers for hoarding behavior in the aftermath of Hurricanes Maria and Irma that devastated Puerto Rico and have contributed to ongoing drug shortages. According to a recent statement from FDA Commissioner Scott Gottlieb, the agency wants to “discourage hoarding of products by some healthcare providers” and is concerned that “shortages of some products may be exacerbated in part because of hoarding behavior.” But, this approach is akin to blaming the victim. If hospitals and medical clinics are hoarding, it’s likely in response to the despicable price gauging tactics of corrupt secondary wholesale distributors peddling shortage drugs at exorbitant prices. Pointing the finger at this group of drug shortage victims is counter-productive and misguided. Instead, FDA should be enlisting the medical community’s help in identifying and reporting potential shortage drug diversion schemes involving corrupt secondary wholesale distributors.
In its July 2012 report on drug shortages, titled Shining Light on the “Gray Market,” Congress found, in part, the following:
- Over the past several years, a growing number of prescription drugs sold in the United States have experienced supply shortages. Because these shortages have been most severe among a group of injectable drugs used to treat patients with cancer and other serious illnesses, they have had a particularly serious impact on hospitals. Hospitals across the country have struggled to provide appropriate care to their patients and have spent hundreds of millions of dollars managing the administrative and clinical problems drug shortages cause.
- During drug shortages, hospitals are sometimes unable to buy drugs from their normal trading partners, usually one of the three large national “primary” distributors, AmerisourceBergen, Cardinal Health, or McKesson. At the same time, hospitals are deluged by sales solicitations from gray market companies offering to sell the shortage drugs for prices that are often hundreds of times higher than the prices they normally pay. Hospital pharmacists have been both angered and confused by these offers. They have asked, “why the hospitals can’t get these products but the ‘scalpers’ can.”
- The drug “pedigree” documents reviewed in this investigation show that some short-supply injectable drugs do not reach health care providers through the manufacturer-wholesaler distributor-dispenser chain that policymakers and industry stakeholders present as the typical model for drug distribution. Instead, these drugs “leak” into longer gray market distribution networks, in which a number of different companies – some doing business as pharmacies and some as distributors – buy and resell the drugs to each other before one of them finally sells the drugs to a hospital or other health care facility.
FDA should look inward at its role in perpetuating the type of shortage drug diversion activity that Congress described in its groundbreaking report more than five years ago. The truth is the agency has done little, if anything, to mitigate this despicable activity. Blaming healthcare providers suggests the agency still doesn’t get it.