Navigating Through a Complex and Inconsistent Regulatory Framework: Section 503B of the Federal Food Drug and Cosmetic Act Outsourcing Facilities Engaged in Clinical Investigation.

The integrity of unbiased clinical data is essential to the future of the health care system by facilitating the discovery of lifesaving medicines and ensuring investigational drugs are safe and effective. Since 2002, the US pharmaceutical industry has invested over $500 billion, which is the largest research and development investment of any sector of the US economy. As a consequence of this significant investment, pharmacy compounders and other stakeholders must be acutely aware of the consequences of noncompliance. Pharmacy compounders are required to navigate through a complex and ever-changing regulatory landscape governed by US federal and state authorities competing for oversight and enforcement authority. In particular, pharmacy compounders participating in clinical investigation are faced with inconsistent federal and state drug labeling regulations, which can lead to enforcement for violating acceptable standards for clinical investigation and informed consent. As FDA registrants, Outsourcing Facilities are able to produce large volumes of clinical supplies without the need for prescriptions for individually named patients. Some states, however, may have prescription drug labeling laws that could thwart the ability to provide these clinical supplies. Accordingly, researchers should be aware of the implications of federal and state laws, including any inconsistencies, prior to engaging in clinical investigation.

Comprehensive Legislative Reform to Protect the Integrity of the 340B Drug Discount Program.

The 40B Drug Discount Program (340B Program) is a federally facilitated program that requires drug manufacturers to provide steep discounts on outpatient prescription drugs to qualifying safety net health care providers. The federal program is intended as a safeguard to ensure access to affordable drugs to the indigeut. However, over the last two decades safety net health care providers have exploited financial incentives under the 340B Program at the expense of drug manufacturers and patients, including the most needy and vulnerable populations-they are committed to serve. Although the federal government has been applauded for increasing effortsto combat health care fraud and abuse including recovering $3.3 billion in 2014, federal officials and the general public have paid markedly less attention to pervasive abuse of the 340B Program. In 2014, drug purchases of 340B-designated drugs totaled $7 billion and are expected to increase to $12 billion: by 2016 as a result of the expansion of the program under the Affordable Care Act. The 340B Program has completely lost its way, and comprehensive legislation is necessary to realign the program with its intent.