An unsettling by-product of our nation’s ongoing drug shortage crisis is that hospitals and medical clinics may be forced to consider unsolicited shortage drug offers from wholesale distributors of unknown legitimacy or employ less-effective, but more available, treatments for some of their most vulnerable patient populations. Nevertheless, as tempting as it may be to turn to questionable sources when this unthinkable scenario arises, the implications of doing so could result in dire consequences for patients and the well-intentioned health care institutions themselves.
In recent years, licensed wholesale distributors in Tennessee and New York were linked by FDA to widely-publicized counterfeit Avastin and Altuzan incidents and other corrupt distributors have been prosecuted in massive drug diversion schemes involving hundreds of millions of dollars in fraudulent drug sales.
Hospitals and medical clinics are also urged to recognize their responsibilities as Dispenser trading partners under the DSCSA. Specifically, hospital pharmacies and other individuals authorized by law to dispense or administer prescription drugs are subject to the DSCSA’s Authorized Trading Partner Requirement for Dispensers under section 582 (d)(3) of the FD&C Act (the Act). Dispensers which engage in transactions with wholesale distributors that are not Authorized are in potential violation of section 301 (t) of the Act and may be subject to corresponding criminal penalties under section 303 of the Act. In order to be Authorized under the DSCSA, wholesale distributors must be licensed and report to FDA, pursuant to sections 503 (e)(1)(A) and (e)(2)(A) of the Act, respectively. This dual requirement is a nuance of the DSCSA that could easily be overlooked by Dispenser trading partners that are not intimately familiar with the law.
Navigating the murky waters of a shortage drug supply chain involving unfamiliar sources of unknown legitimacy is a risky proposition for hospitals and medical clinics in desperate need of effective treatments in short supply. Going down this path, however, is rife with potential pitfalls and should not be undertaken without extreme vetting of all direct sources and previous owners of the products to prevent the receipt of suspect and illegitimate products that place the health and safety of vulnerable patients at risk and expose healthcare institutions to potential criminal liability under the FD&C Act.
***Disclaimer-I am not an attorney. The above represents my observations on this issue only and is not intended to replace qualified legal advice.