REMS/Sample Acquisition Remedies

WASHINGTON DC (June 14, 2018) – Today, the Senate Judiciary Committee, on a strong bipartisan basis, has taken a critical first step toward making real progress on the problem that U.S. patients care the most about: high drug prices. The full Senate and the House should follow the Judiciary Committee’s lead and pass a strong CREATES Act so President Trump can sign into law this important legislation that will help fulfill the goals of his American Patients First plan.

WASHINGTON DC (May 31, 2018) – AAM applauds FDA for issuing these guidances to address one form of brand gamesmanship that has delayed generic and biosimilar competition and price reductions for patients. Calls for voluntary action by brand companies to stop their efforts to thwart generic competition are not enough.

Congress Signals Intention to Pass Legislation Needed to End Games

WASHINGTON DC (May 17, 2018) – Today, the Food and Drug Administration (FDA) for the first time publicly identified brand-name pharmaceutical companies who abuse FDA’s safety programs or erect their own restricted distribution systems without an FDA mandate to delay competition from generic and biosimilar manufacturers. These anti-competitive tactics artificially extend the monopolies on blockbuster brand drugs and keep drug prices high for millions of patients.

Administration’s Plan Embraces Getting More Generic and Biosimilar Medicines to Patients

WASHINGTON DC (May 11, 2018) – In President Trump’s remarks today at the White House, he made clear the essential role that generic and biosimilar medicines play in containing prescription drug costs for patients.