The president’s fiscal 2012 budget proposal is seeking a budget increase for the Food and Drug Administration as well as a bump in its staff size.
This request comes at a difficult time, as lawmakers are intent on cutting budget deficits. The administration’s call for a bigger FDA budget is not unfounded though. In many direct ways, and more than most government agencies, the FDA impacts the life of every American, everyday.
Biotechnology companies will be watching keenly to see how the agency’s 2012 budget proposal fares in Congress, given the FDA’s role in reviewing and approving new biotechnology-derived medicines and agricultural products.
The FDA’s impact is far-reaching: It is responsible for the quality and safety of most of the food Amercians eat, all of the medications they take, the cosmetics they use, the medical devices and diagnostic tests used in hospitals, and much more.
The Alliance for a Stronger FDA, of which BIO is a member, points out on its website that 25 cents of every consumer dollar spent in the United States goes to products that fall under FDA purview. To meet this challenge, Congress currently authorizes that the agency spend about $8 per year for each American. Just a minor increase would go a long way toward helping the FDA improve its operations, suggests the alliance.
As the alliance notes on its site: “Nowhere else in the federal budget does so little money need to go so far. The FDA has just 10,000 employees to monitor food safety, review the safety and efficacy of medical products, assure the safe use of those medical products, and protect the American people, their pets and their farm animals from poorly made, counterfeit and illegal food, drugs and cosmetics.”
The Senate Appropriations Subcommittee on Agriculture, Rural Development, FDA and Related Agencies held a recent hearing to discuss the FDA fiscal 2012 budget proposal. FDA Commissioner Dr. Margaret Hamburg outlined four new agency initiatives that would be supported by the budget proposal:
transforming food safety and nutrition;
advancing medical countermeasures;
achieving the Regulatory Science and Facilities Initiative.
“These four initiatives are critical to our mission of protecting and promoting the health of the public,” explained Hamburg. “They also represent important opportunities for our food and medical product industries to grow and strengthen our economy. In other words, they will provide the significant return on investment that we are all looking for, for products, for people and for the public health.”
If approved, the new funding would go directly to helping the FDA achieve the four initiatives, she told lawmakers. Further, one of the agency’s additional objectives is to implement a pathway for biosimilar products.
Ultimately, the funds would help the agency modernize and streamline all of its regulatory work, Hamburg told lawmakers.
The Alliance for a Stronger FDA urges Congress to adequately fund FDA's essential missions.