New Law Aims to Accelerate Drug Approvals and Enhance Safety
- By BSTQ Staff
On July 9, President Obama signed into law the Food and Drug Administration (FDA) Safety and Innovation Act, also known as S. 3187. The new regulation will help provide the FDA with the resources needed to continue to bring effective and safe drugs and devices to patients.The law also will maintain the nation’s role as a forerunner in biomedical innovation and will protect the jobs maintained by drug and medical device development. S. 3187 is expected to increase patient access to affordable medicines by driving the review of innovator drugs and devices, implementing the program proposed in the president’s 2013 budget to accelerate approval of lower-cost generic drugs, and funding the new approval pathway for biosimilar biologics created by the Affordable Care Act. It also will require manufacturers of certain drugs to notify the FDA when they experience circumstances that could possibly lead to a national drug shortage. The new legislation will support the enhancement of drug supply chain safety in a market where counterfeiting is commonplace. Incentives have been put in place to increase the development of new antibiotics and innovative mechanisms to guarantee that children’s medications are properly tested and labeled. In addition, the Act will expedite the development and review of drugs created for the treatment of serious and life-threatening illnesses.