Food and Drug Administration Reform Act of 2012

Floor Speech

By:  Bill Pascrell, Jr.
Date: May 30, 2012
Location: Washington, DC


Mr. PASCRELL. Mr. Speaker, I stand today to support H.R. 5651--Food and Drug Administration Reform Act of 2012, which reauthorizes the Federal Drug Administration's (FDA) prescription drug and medical device user fee programs through 2017. This legislation will provide the FDA the ability to collect user fees from drug and medical device companies to help fund its reviews of their products. These user fee programs provide the FDA the resources to enable the efficient review of applications and give patients access to therapies at the earliest possible time, and most importantly, help prevent drug shortages that threaten public health.

I am supportive of the legislation because it will authorize a new user fee program for generic drugs, resulting in decreased review times, and it authorizes user fee program for biosimilars, thus ensuring parity. Additionally, the legislation reauthorizes and makes permanent two complementary pediatric drug programs, which foster the development and safe use of prescription drugs for children.

Further, the legislation will assist in the modernization of the FDA's global drug supply chain authority, resulting in improved safety of our prescription drugs The legislation will also provide new incentives for the development of antibiotics to address the public health threat of antibiotic resistance. Finally, the bill includes important provisions to help prevent and mitigate drug shortages, which have unfortunately now become an all-too-frequent occurrence.

Ultimately, the legislation will ensure that Americans have access to crucial medicines and medical devices, improves access to new and innovative medicines and devices, helps prevent and mitigate drug shortages and reduces drug costs for consumers by speeding the approval of lower-cost generic drugs.


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