by Amanda Conschafter, blog editor
A bill recently passed in the U.S. House of Representatives could help members of the prescription drug supply chain comply with controlled substances law – and ensure patients access to the medications they need. HR 4709, the Ensuring Patient Access and Effective Drug Enforcement Act, combines its bipartisan sponsors’ desire to curb diversion, specifically of opioid pain pills, with its acknowledgment of patients’ needs. Should the bill clear the U.S. Senate, it may help address widespread concern about prescription drug abuse.
H.R. 4709 clarifies the Controlled Substances Act in two key ways. The bill allows regulators to suspend or revoke the license of registered supply chain stakeholders to distribute controlled substances in situations where diversion occurs or public health concerns arise. But the bill also allows those found in violation to respond by submitting a corrective action plan.
Giving suppliers and distributors found in violation the chance to comply with the Act’s requirements helps to ensure that access is not hindered for patients weigh legitimate medical need. As discussed in IfPA’s recent white paper, policymakers have been seeking solutions that balancing the imperative to curb abuse with the responsibility to maintain patient access.
Sponsors of the bill also seek broader insight into the multi-faceted issue of prescription drug diversion. The bill requires the Food and Drug Administration, Drug Enforcement Agency, Office of National Drug Control Policy, and Centers for Disease Control and Prevention to collaborate on a report to Congress regarding controlled substance diversion and patient access issues within a year of the law’s enactment.
H.R. 4709 has been referred to the U.S. Senate’s Health, Education, Labor and Pensions Committee for further consideration.