GPhA Supports Restricted Access Bill

September 18, 2014
BioPharm International Editors

GPhA throws its support behind a bill to prohibit companies from using REMS practices to deter competition.

The Generic Pharmaceutical Association has expressed its support of a bill introduced by Representatives Steve Stivers (R-OH) and Peter Welch (D-VT) that calls for reforms to FDA risk evaluation and mitigation strategies (REMS) programs. According to GPhA, the bill would prohibit companies from using restricted access practices to avoid generic competition. The bill would establish legal requirements and processes for the acquisition of product samples by generic and biosimilar developers.

“This important bill introduced today by Congressmen Steve Stivers (R-OH) and Peter Welch (D-VT) promises to prevent unnecessary delays for patients waiting for generic choices and save billions for taxpayers, patients, and the federal government,” said Ralph G. Neas, president and CEO of GPhA, in a press release. “These programs should be established for what Congress intended: keeping patients safe. Instead, some companies have adopted business strategies that deter competition under the guise of safety. This bill would put an end to that regrettable practice,” said Neas.

Source: GPhA