President Barack Obama signed into law the Food and Drug Administration Safety and Innovation Act on Monday.
The legislation amends the Federal Food, Drug and Cosmetic Act to establish user-fee programs for generic drugs and biosimilars and to revise and extend the user-fee programs for prescription drugs and medical devices, among other purposes, according to GovTrack.
“This legislation, which passed both the House and Senate with overwhelming bipartisan majorities, will help speed safe and effective medical products to patients and maintain our nation’s role as a leader in biomedical innovation,” Department of Health and Human Services Secretary Kathleen Sebelius said in a news release.
The law is expected to fund the new approval pathway for biosimilars created by the Affordable Care Act, impel timely review of new drugs and medical devices, and implement the program proposed in the 2013 president’s budget to accelerate approval of lower-cost generic drugs.
“These new programs are important to increasing patient access to affordable medicines,” Sebelius said.
The legislation will also enhance the FDA’s ability to combat drug shortages by requiring manufacturers to notify the FDA when circumstances could lead to a potential shortage.
“Provisions in the legislation also will help enhance the safety of the drug supply chain in an increasingly globalized market, increase incentives for the development of new antibiotics, renew mechanisms to ensure that children’s medicines are appropriately tested and labeled, and expedite the development and review of certain drugs for the treatment of serious or life-threatening diseases and conditions,” Sebelius said.