AAM unveils push for CREATES Act passage

WASHINGTON — The Association for Accessible Medicines has rolled out a new video and infographic in support of its campaign for patients to call on their representatives to support legislation supporting the generics industry. The materials outline AAM’s case for passing the Creating and Resorting Equal Access to Equivalent Samples Act.

The legislation was introduced in April in the Senate by Sen. Patrick Leahy, D-Vt.., with an identical bill introduced in the House by Rep. Tom Marino, R-Pa. It aims to make it easier for generics makers to access drug samples of branded products when trying to develop a generic version, many of which are protected by Risk Evaluation and Management Strategies, even when the Food and Drug Administration doesn’t require one. REMS abuse has been mentioned by FDA commissioners Dr. Scott Gottlieb as something that the agency needs to address as part of its Drug Competition Action Plan.

“Fortunately, the FDA has recognized these abuses, noting that they disadvantage patients in the form of higher prescription drug costs,” AAM wrote in a blog post. “Bipartisan leaders in Congress have introduced legislation that would close the loopholes and ensure patients benefit from the timely entry of more affordable versions of these high-cost branded medicines.”