Category: FDA

“Common Rule” Overhaul Proposed – Intended to Modernize Human Research Subject Protections

On September 2, 2015, sixteen federal agencies and departments jointly issued a Notice of Proposed Rulemaking (“the NPRM”), designed to “modernize, strengthen, and make more effective” the so-called “Common Rule”.  The Common Rule is a uniform federal policy for the Protection of Human Subjects, originally issued in 1991. The U.S. agencies […]

Significant Court Decision Issued Today re: Off-Label Promotion

A highly anticipated decision was issued today in the U.S. District Court for the Southern District of New York in the case, Amarin Pharma Inc. et al. v. Food and Drug Administration et al. (case no. 1:15-cv-03588). See this blog post for additional background on the case. In a detailed 69-page decision, […]

FDA Launches New REMS Website

The U.S. Food and Drug Administration (FDA) launched this week REMS@FDA, a Risk Evaluation and Mitigation Strategy (REMS) database website. The new, user-friendly website contains a table of all currently approved individual and shared REMS, as well as a link to historical REMS. The table provides an at-a-glance overview of elements included […]

Case to Watch: Amarin Pharma v. FDA

A potentially significant case being watched by the pharmaceutical industry is Amarin Pharma, et al., v. U.S. Food and Drug Administration, et al., Civ. A. 15-cv-3588 (S.D.N.Y.). The complaint, filed in May 2015, is a “First Amendment challenge to FDA regulations that prohibit Amarin, a pharmaceutical company, from making completely truthful and non-misleading […]

Lawmakers release new version of 21st Century Cures legislation

Yesterday, a bipartisan group of representatives from the House of Representatives’ Energy and Commerce Committee released a new discussion draft of the 21st Century Cures initiative.  This draft is the latest step in the Committee’s year-long attempt to accelerate new medical innovations and improving the way they are brought to market.  According […]

FDA Submits Notice for Collection of Information Regarding Direct-to-Consumer Advertisements

The Food and Drug Administration (FDA) recently submitted a proposed collection of information on disclosing risks in direct-to-consumer (DTC) prescription drug television (TV) advertisements to the Office of Management and Budget (OMB) for review and clearance. According to the notice published in the Federal Register on January 13, 2015, prescription […]

No More Paper PIs? FDA Issues Proposed Rule on Electronic Distribution of Prescribing Information

Yesterday, the U.S. Food and Drug Administration (FDA) announced a proposed rule to require electronic distribution of the prescribing information intended for health care professionals (often called the “PI”) for human prescription drugs, including biological products (the “Proposed Rule”).  Currently, although manufacturers often voluntarily make their product PIs available electronically, they are […]