Senate Passes Food and Drug Administration Safety and Innovation Act

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On June 26, 2012, the U.S. Senate passed the Food and Drug Administration (FDA) Safety and Innovation Act by a 92-4 vote, which the U.S. House of Representatives passed on June 20, 2012 by a voice vote. The FDA Safety and Innovation Act will provide more than $6 billion in industry user fees to the FDA over the next five years to fund the Agencys review of new drugs and medical devices. The full text of the FDA Safety and Innovation Act can found here.

Although the FDA receives money from Congress each year, a large portion of the Agencys budget comes from user fees it receives from manufacturers of drugs and medical devices. Under the new legislation, the FDA is expected to collect $693 million from drug manufacturers through next year, and $595 million from medical device manufacturers through 2017. Consequently, the Congressional Budget Office projects that the legislation will reduce federal spending by $311 million over the next 10 years.

The additional funds will enable the FDA to more quickly review new drugs and medical devices. Therefore, the legislation is expected to help the FDA bring critical drugs and medical devices to market faster, protect patients from drug shortages and manufacturing problems, and enhance the availability of low-cost generic drugs.

Fuerst Ittleman will continue to monitor the legislation as it is enacted and implemented. For more information about the FDA Safety and Innovation Act or FDA regulatory compliance, please contact us at contact@fidjlaw.com.