Tuesday, 04 April 2017 10:02

Food and Drug Administration FY 2018 Appropriations Statement

The American Society for Microbiology (ASM) recommends that Congress increase funding for the Food and Drug Administration (FDA) by at least 3 percent for FY 2018, raising the agency’s budget authority to $2.8 billion by adding $78 million. The proposed level is needed to support the many FDA programs that protect the nation’s public health and safety. We also urge that Congress make available the additional $60 million needed by FDA to implement specific provisions of the 21st Century Cures Act passed by Congress last year.

The ASM urges Congress to reject the Administration’s proposal to offset a third of the FDA’s appropriated budget with an increase in medical product industry user fees. FDA’s core responsibilities, safe and effective medical products and safe foods, should be supported by federal funding. Industry user fees have always been intended to supplement, not replace, federal funding for FDA. In addition, the drug and device industries have already completed user fee agreement negotiations with FDA, setting the appropriate amount of industry fees to support FDA reviews.

Congress should recognize the significance of FDA’s mission to protect the public health and support FDA with public funding. FDA regulatory, educational, and research programs must be consistently and adequately funded. FDA is charged with ensuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices, both domestic and imported. It also is responsible for the safety and security of our Nation’s food supply, dietary supplements, products emitting electronic radiation and cosmetics, and for regulating tobacco products. FDA regulated products account for about 20 cents of each consumer dollar. Ensuring their safety and efficacy affects our daily lives as well as the U.S. economy.

It is essential that Congress provide strong, continuing funding in FY 2018 for the FDA. Agency responsibilities continue to expand steadily because of legislation like the new 21st Century Cures Act and the Food Safety Modernization Act (FSMA) passed by the Congress in 2011. Each year, FDA is a key participant in newly launched federal initiatives such as those promoting precision medicine or combatting antibiotic resistant infections. Growing demands on FDA resources also are being pushed by the increasingly complex landscape of U.S. health care and the bioeconomy, burgeoning volumes of domestic and imported consumer goods, our highly diverse food supply, and marketplace globalization.

We urge Congress to support FDA’s access to the latest science and technology when performing its regulatory duties, strengthening FDA capabilities like those deployed during the Nation’s response to emerging Zika virus. In 2016, FDA issued a new guidance on deferring blood donations from individuals exposed to Zika virus, and another with recommendations to reduce potential Zika transmission from human cells and tissues. It then approved a rapid test to screen blood donations for Zika virus. The agency had expedited its availability as an investigational new drug, an example of how FDA partners with industry and other agencies to respond rapidly to health emergencies. FDA scientists announced a new mouse model developed at FDA laboratories to accelerate development of Zika vaccines and therapeutics.

Other science based actions taken last year by FDA further expanded the nation’s health care product pipeline, including approvals of two drugs for hepatitis C, a new treatment for inhalation anthrax, and a vaccine to prevent cholera for travelers. FDA also advanced the Precision Medicine Initiative with draft guidances for oversight of next generation DNA sequencing tests. In 2016, FDA finalized its rule revising annual reporting requirements for all antimicrobials used in animals intended for human consumption or food producing animals, to further ensure judicious use of medically important therapeutics. It also cleared for marketing the first test to detect carbapenem resistant Enterobacteriaceae in clinical samples, to more quickly detect resistant pathogens in patients. In February, FDA cleared the first test of patient levels of the protein procalcitonin to guide antibiotic use in sepsis and respiratory infections. The same day, it approved marketing the first rapid test to identify bloodstream pathogens and provide antibiotic sensitivity information.

The ASM urges Congress to provide adequate support in FY 2018 to sustain FDA’s oversight of the vast, complex food supply in the United States. The FDA is primarily responsible for 80 to 90 percent of our food, with the U.S. Department of Agriculture safeguarding the remainder. This protection is being compromised by increasing proportions of the food supply imported from other countries, a population more susceptible to illness, and diets with more raw foods. The most recent federal estimates indicate about 48 million people, or 1 in 6 Americans, get sick each year with foodborne illness. Of these, 128,000 are hospitalized and 3,000 die. In 2015, FDA estimated that related health care costs reached about $36 billion annually.

We urge Congress to support FDA’s mission to safeguard the Nation’s health, facilitate discovery of new products, and stimulate global competitiveness in science and technology. We appreciate this opportunity to submit a statement in support of FDA and offer our assistance to the Congress during the budget process.