Senate panel considers bill aimed at getting generic drugs to market faster
The Senate Judiciary Committee discussed the Creating and Restoring Equal Access to Equivalent Samples Act on June 7.
The Senate Judiciary Committee discussed the Creating and Restoring Equal Access to Equivalent Samples Act on June 7. The legislation is designed to get generic drugs to market faster by preventing brand drug companies from using the regulatory process known as risk evaluation and mitigation strategies (REMS) to keep drug samples from generic companies. Generally, a generic company needs about 5,000 doses to run all trials and gain and FDA approval. The legislation was introduced in October 2017 but has been in limbo because of strong opposition from the pharmaceutical industry. However, Sen. Charles Grassley (R-IA), the chairman of the Judiciary Committee, says opposition to the bill will disappear if legislators will lighten up on changes to how Medicare charges are calculated. His committee is already talking to the House Energy and Commerce Committee to shape legislation that might move more smoothly.