FDA Safety Regs Under Scrutiny

By Rheingold Giuffra Ruffo & Plotkin LLP

The Food and Drug Administration’s (FDA) strategy for managing drug risks-Risk Evaluation and Mitigation Strategies (REMS)- has garnered national attention for its lack of success in executing policies for drug regulation. Due to The Office of the Inspector General’s recent report, which questioned the efficacy of the FDA’s current approach on drug regulation, the report also shed light on how inconsistent REMS has become.

Risk Evaluation and Mitigation Strategies (REMS) are implemented by the FDA when federal watchdogs believe a certain drug has untold risks that the agency should be wary of. In the late 1990s, “voluntary” agreements were made with the drug makers and the agency to essentially ensure smooth and effective regulations for mass-market production. In 2007, “voluntary” agreements became federal regulations as the FDA received legal permission from Congress to pursue explicit arrangements between the FDA and drug makers for approval.

However, control is lost when drug makers that are legally bonded by the FDA then rely on doctors to enforce the same regulations without the monitoring capabilities the FDA imposes on the drug makers. Unless new enforcement strategies are introduced for the FDA, there are no current ways for drug makers to report back accurate and compliant results the FDA has sought.

Scott Gottlieb, a practicing physician and a Resident Fellow at the American Enterprise Institute in Washington said the following: “In a fragmented drug supply chain, it is hard for the drug makers to ‘cut off’ the doctors that don’t comply with all the previsions, and it might not be desirable. True enough; the REMS give some comfort to drug regulators who might be concerned about how doctors would prescribe a newly approved drug that had certain significant risks. But the challenges that FDA is having with implementing, and monitoring these plans should be a reminder that the agency doesn’t have as much leverage over medical practice as they would desire.”

While the Office of the Inspector General wishes to give the FDA more legislative and enforceable power, there have yet been any significant changes in the FDA to produce desirable results. Recommendations have been made and both the FDA and the OIG have been responsive to the feedback.

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