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Patricia O'Connell
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Bert Rein Authors Pharmaceutical Executive Column Proposing Modernization of Post-Approval Prescription Drug Regulation

December 5, 2013

In a column published by Pharmaceutical Executive, Wiley Rein founding partner Bert W. Rein has offered a groundbreaking proposal for modernizing federal oversight of approved prescription drugs.

The current U.S. system for regulating prescription medication use after initial marketing approval does not adequately protect patient safety and is even weaker on the efficacy side, according to Mr. Rein, who has been recognized as a Washington “Visionary” by The National Law Journal and a “Leading Food and Drug Lawyer” by the Legal Times.

Mr. Rein’s November 27 column, entitled “Let’s Modernize the Post-Approval Regulation of Prescription Drugs,” proposes a new, web-based regime for monitoring a medication’s safety and effectiveness and improving patients’ access to the best available information on a product’s full therapeutic potential.

The proposed system would vastly improve the current post-approval regulatory structure, which was conceived more than 50 years ago and does not reflect the current reality of how medical knowledge evolves.  The reform envisioned by Mr. Rein “is both possible and practical,” he says in the Pharmaceutical Executive column.

To read Mr. Rein’s article on Pharmaceutical Executive’s website, click here.