- To discuss the purpose of using voluntary restricted distribution systems in the pharmaceutical supply chain.
- To examine how a manufacturer may use a restricted distribution system to delay or block generic competition.
- To expedite the introduction of generic medications, the Abbreviated New Drug Application allows the FDA to rely upon its previous finding of safety and effectiveness for the approved medicine if a generic manufacturer shows that its medicine is bioequivalent.
- In order to conduct studies and show bioequivalence, a generic manufacturer must obtain samples of the approved medicine. In some instances, there are legitimate distribution restrictions on medications with safety concerns – the Risk Evaluation and Mitigation Strategies (REMS) program provides the FDA authority to require such restrictions as it deems necessary.
- Some manufacturers also self-impose distribution restrictions; at least one manufacturer misused a restricted distribution system.
- A 2014 study found that misuse of restriction distribution systems potentially costs the health care system an estimated $5.4 billion annually.
Senior Vice President and General Counsel, Momenta Pharmaceuticals
Testifying on behalf of the Association for Accessible Medicines (AAM)
Director, Center for Hospital Finance and Management
Professor, Johns Hopkins Bloomberg School of Public Health
President and Founder
Patients for Affordable Drugs