The American Society for Microbiology (ASM) wishes to submit the following written testimony on the Fiscal Year (FY) 2012 appropriation for the Food and Drug Administration (FDA). The ASM is the largest single life science organization in the world with over 38,000 members. The ASM mission is to enhance the science of microbiology, to gain a better understanding of life processes and to promote the application of this knowledge for improved health and environmental well being.
The ASM supports the Administration’s request of $4.36 billion for FDA in FY 2012 an increase of $1.08 billion above the FY 2010 enacted level. The request comprises new budget authority of $2.74 billion, which would raise FDA’s program funding by $382 million, plus current and proposed user fees. The FDA regulates products valued at about 20 cents of every dollar spent by Americans and protects us from unsafe foods and other consumer goods. Additional resources are needed for FDA to fulfill its vast oversight responsibilities.
The FDA evaluates the safety, efficacy and security of an enormous product list that includes human and veterinary drugs, biological products like donated blood and tissue, medical and radiation emitting devices, cosmetics, tobacco and 80 percent of the US food supply. The FDA shares responsibility with other federal agencies to guarantee national security. It secures the nation’s food and drug supply and facilitates development of medical countermeasures against both deliberate and naturally occurring public health threats. The FDA provides extensive science based information for consumers and regularly interacts with industry to protect the public against unsafe or mislabeled products.
External reviews of FDA have pointed to funding and personnel shortages as reasons for the Agency’s problems with fulfilling all its regulatory duties. In January, the General Accountability Office (GAO) reported that FDA needs added authority to assess potentially false or misleading food labeling. Last year, the Institute of Medicine released recommendations for better FDA oversight of drug safety, medical devices, certain clinical trials and food safety. FDA programs clearly face serious challenges complicated by globalization, budget shortfalls, rapidly advancing technologies, including synthetic biology and growing consumer demand for new products.
The ASM commends FDA efforts in its recently drafted Strategic Action Plan for 2011–2015 to remediate regulatory deficiencies. Additional resources will be needed to achieve the plan’s four cross-cutting priorities: (1) Advance Regulatory Science and Innovation; (2) Strengthen the Safety and Integrity of the Global Supply Chain; (3) Strengthen Compliance and Enforcement Activities to Support Public Health; and (4) Address the Unmet Public Health Needs of Special Populations.
Ensuring a Safe US Food Supply
The President’s budget requests nearly $1.4 billion allocated for FDA’s Transforming Food Safety and Nutrition Initiative, which is about $326 million above the FY 2010 level. The request includes funding for foods and nutrition, and for animal drugs and feeds, cosmetics, food labeling and dietary supplements. The FY 2012 budget would allocate $303 million for FDA’s Center for Food Safety & Applied Nutrition (CFSAN), about $67 million more than FY 2010 (including user fees). Field activities would receive over $732 million to help improve food safety in this country, an increase of $187 million above FY 2010.
The FDA budget addresses recommendations from the President’s Food Safety Working Group and provisions in the Food Safety Modernization Act (FSMA). FDA’s responsibilities for a safe US food supply are enormous. It regulates all domestic and imported food other than meat, poultry, and frozen, dried and liquid eggs. The Agency regulates $417 billion worth of domestic food and $49 billion of imported foods and oversees approximately 167,000 registered US food establishments and 254,000 registered foreign facilities. In 2010, FDA also responded to the Gulf oil spill, deploying mobile labs to assess seafood safety. More recently, FDA actions are safeguarding the US population from nuclear affected foods and dairy products associated with the Japan nuclear catastrophe.
The nation’s $1 trillion food industry provides incalculable opportunities for foodborne mishaps to cause harm, through production, processing, manufacturing, restaurants and retail outlets. Last August, FDA initiated a nationwide recall of more than 500 million eggs potentially contaminated with Salmonella bacteria. Over 1,600 reported human infections eventually were associated with contaminated shell eggs. The outbreak occurred just as FDA’s new long delayed egg rule went into effect, applying more stringent legal standards on large egg producers and authorizing more plant inspections. It also illustrated the urgency and complexities of combating foodborne illness. The USDA regulates egg product processing facilities, while FDA is responsible for eggs still in their shells as well as egg products post breaking facility.
Foodborne illnesses affect one out of six Americans every year. A 2010 study calculated US healthcare related costs at $152 billion annually. The FDA estimates that industry costs of the 2008 peanut product recall exceeded $1 billion. The burden of foodborne illness can be dramatically reduced. Resources are needed to improve food safety at farms growing fresh produce and expanded testing of high priority products like seafood and animal feeds under the interagency surveillance network, the National Antimicrobial Resistance Monitoring System.
For FY 2012, the FDA estimates its staff will make 12,099 US food establishment inspections and its laboratories will analyze 10,305 related samples, compared with FY 2010’s 8,745 visits and 12,173 samples. Imported foods demand more FDA resources as imports multiply in both variety and number, accounting for an estimated 15 percent of the US food supply, 60 percent of fresh fruits and vegetables and 80 percent of seafood. The FSMA bill expanded FDA oversight by requiring that importers verify the safety of their foods, giving FDA authority to block foods from countries or facilities that refuse FDA inspection. The FDA will increase its foreign inspections to an estimated 1,044 in FY 2012 versus 354 in FY 2010.
Protecting the US Public with Safe, Effective Products
The FY 2012 budget request for FDA’s Protecting Patients Initiative provides $1.38 billion for the FDA oversight of human and animal health related products. Surveillance and prevention can slow the rising costs of US healthcare, product recalls and adverse patient events associated with these products. The FY 2012 request, which includes user fees, adds needed resources for the FDA centers and field activities that regulate these products, including the Center for Veterinary Medicine (CVM), the Center for Drug Evaluation & Research (CDER), the Center for Devices & Radiological Health (CDRH) and the Center for Biologics Evaluation Research (CBER).
The FDA’s mission is to protect the US public against unacceptable products, both premarket and post market. Agency oversight of vaccines, drugs, devices, biologics like transplant tissues, and animal feeds entails labor intensive inspections and laboratory analyses complemented by technology dependent surveillance systems. Communication technologies must be up to date. Each year, FDA education campaigns reach multimillion sized audiences of consumers, manufacturers, producers, retailers and public health officials in this nation and abroad.
The FY 2012 request prioritizes FDA regulatory mechanisms to approve cost saving biosimilars, alternative therapies to higher priced biological products whose patents have expired. The FDA estimates that savings could reach $7 billion through FY 2019. At present, US patents have expired on relevant products worth more than $15 billion in annual sales. FDA already regulates generic drugs that cost consumers 20 to 70 percent less than brand name drugs, saving the US healthcare system an estimated $8 billion to $10 billion a year. FDA CDER activities target fraudulent products further reducing health costs. For example, as of November 2010, FDA had issued 95 warnings about 185 fraudulent pandemic H1N1 flu products, saving consumers wasted dollars and possible illness.
Building FDA Science & Technology
The FDA defines regulatory science as “the science, the tools and the standards needed to assess and evaluate the efficacy, quality and performance of a food or medical product.” FDA’s seven research and product centers and more than 12,000 personnel worldwide must be able to access leading edge scientific knowledge and technical tools. FDA science has suffered from minimal funding in past years, but today’s globalized markets and rapidly emerging technologies like nanoscience and genomics require FDA to evaluate radically new products. Regulatory science differs from R&D programs in industry and academia in its focus on knowledge and tools that can optimize product assessments. FDA science in this area must be increased in the FY 2012 appropriation.
Last year, the FDA established a Regulatory Science Initiative to strengthen the Agency’s scientific decision making and accelerate the development of safe, high quality products. The Agency’s new Strategic Plan emphasizes advancing regulatory science and innovation. The ASM endorses the FY 2012 budget’s increased resources for better FDA science capabilities. The CFSAN budget, for example, underwrites better tools to evaluate and set standards for emerging food technologies like nanoengineered particles, food irradiation and genetically engineered plants.
The FY 2012 budget provides an additional $70 million to strengthen FDA’s role in the national imperative for advanced medical countermeasures (MCM) against chemical, biological, radiologic and nuclear threats, as well as naturally emerging infectious diseases. The MCM funding request addresses recommendations from the National Biodefense Science Board and other reviews that identified FDA’s urgent need for greater MCM related resources.
The ASM recommends that Congress approve the Administration’s FY 2012 budget for the Food and Drug Administration’s oversight of more than $2 trillion worth of consumer goods. This investment is needed to improve public health, new product development and strengthen the FDA’s critical oversight role.