FOR IMMEDIATE RELEASE
July 9, 2012Contact: HHS Press Office
Statement from HHS Secretary Kathleen Sebelius on the signing of the Food and
Drug Administration Safety and Innovation Act
Today, the President signed into law S. 3187, the “Food and Drug Administration
Safety and Innovation Act.” 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.
S. 3187 is the culmination of the work of the administration and Congress, in
partnership with patients, the pharmaceutical and medical device industries, the
clinical community, and other stakeholders, to provide the Food and Drug
Administration with the tools needed to continue to bring drugs and devices to
market safely and quickly and promote innovation in the biomedical industry, and
to help secure the jobs supported by drug and device development.
This legislation will drive timely review of new innovator drugs and medical
devices, implement the program proposed in the 2013 President’s Budget to
accelerate approval of lower-cost generic drugs, and fund the new approval
pathway for biosimilar biologics created by the Affordable Care Act. These new
programs are important to increasing patient access to affordable medicines.
S. 3187 also enhances the tools available to the FDA to combat drug shortages by
requiring manufacturers of certain drugs to notify the FDA when they experience
circumstances that could lead to a potential drug shortage. This is consistent
with the administration’s request to Congress to complement the actions directed
by the 2011 Executive Order to address this significant public health issue.
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.
While enactment of S. 3187 marks an important moment for innovators across
industry, research and clinical care settings, its most important beneficiaries
are the patients and families that will be helped by the next generation of
affordable medical products this bill will help to foster.