On March 17, 2016, the Senate passed two independent bills in response to growing concerns with the Zika virus outbreak and current opioid painkiller prescribing practices. The Senate bill addressing the Zika virus aims to fuel the development of countermeasures to address the Zika virus outbreak by providing for expedited US Food and Drug Administration (FDA) approval of drugs targeting the Zika virus. The Senate bill addressing opioid painkiller prescribing requires coordination among federal agencies, state and local government and the health care industry to identify the obstacles to proper opioid prescribing and resolve the identified issues.
Adding Zika Virus to the FDA Priority Review Voucher Program Act
Senate Bill 2512 (114th Congress) amends the Federal Food, Drug and Cosmetic Act (FDCA) to add the Zika virus to the list of eligible diseases subject to FDA’s priority review voucher (PRV) program. The FDA’s PRV program enables developers of drugs for which there is no significant market potential, but which drugs target diseases disproportionately affecting poor and marginalized populations (i.e., certain tropical and qualifying infectious diseases), to obtain expedited FDA review and approval. Drug developers and manufacturers are encouraged to take advantage of this expedited FDA regulatory approval process and potential market opportunity.
Ensuring Patient Access and Effective Drug Enforcement Act of 2015
Senate Bill 483 (114th Congress) amends the Controlled Substances Act, establishing a general framework for collaboration among federal agencies to address the growing concern with proper and effective opioid painkiller prescribing. The intention is that greater federal oversight and collaboration with the health care industry will highlight the problems with current prescribing practices and establish a uniform platform for developing a solution for both providers and patients. In response to these same concerns, the CDC recently issued new guidelines for recommended opioid prescribing.
Specifically, this bill requires that the Secretary of the Health and Human Services (HHS), in concert with other federal agencies, prepare a report identifying the following items: (1) obstacles to legitimate patient access to controlled substances, (2) issues with diversion of controlled substances; (3) the availability of medical education and training opportunities for proper pain management and opioid prescribing, (4) beneficial enhancements to State prescription drug monitoring programs; (5) how collaboration between Federal, State, local and tribal law enforcement agencies and the pharmaceutical industry can benefit patients and prevent diversion; and (6) steps to improve reporting requirements so that the public and Congress have better information concerning prescription opioid painkillers and prescribing practices.
*Blake Walsh is admitted only in Tennessee. Her practice is supervised by principals of the firm admitted in the District of Columbia.