Congress Prescribes Deeper Delve into Rogue Online Pharmacies with PDUFA Reauthorization

Yesterday, the Senate followed last week’s House action and agreed to renew the bipartisan S. 3187– the “Food and Drug Administration Safety and Innovation Act” (PDUFA). This legislation is instrumental in fostering innovation in the pharmaceutical and biomedical sectors, and providing Americans with access to safe, FDA-approved medicines.

Also included in the PDUFA text is section 1134, which requires the U.S. Government Accountability Office (GAO) to prepare a report on illegal online drug sellers. This follows a recent call from the U.S. Chamber of Commerce, and the Alliance of Safe Online Pharmacies, Federation of State Medical Boards, and other associations for Congress to delve deeper into the issue of rogue online pharmacies, which are responsible for deceiving consumers into purchasing unsafe and sometimes downright dangerous medicines.

Rogue online pharmacies represent a clear danger to public health, with some estimates finding nearly 96% of online pharmacies are selling counterfeit or substandard medicines that do not meet state or federal laws designed to protect patient safety.

The GAO report that will result from PDUFA’s reauthorization is a significant step in the right direction for better understanding the scope and reach of rogue internet pharmacies. We here at the GIPC commend the passage of PDUFA and look forward to finding workable solutions in addressing the burgeoning online market for counterfeit, unsafe medicines.

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