The American Society for Microbiology (ASM), the largest single life science Society with over 39,000 members, wishes to submit a statement in support of increased funding in FY 2015 for the Food and Drug Administration (FDA). The FDA plays a unique and essential role in protecting public health by assuring the safety and efficacy of products accounting for more than 20 percent of all consumer spending in the United States. FDA science based regulatory oversight covers the Nation’s food supply, human and veterinary drugs, vaccines and other biological products, medical devices and more. Market globalization and advances in science and technology have significantly increased FDA’s responsibilities in recent years. FDA’s current strategic priorities include modernizing regulatory science capabilities and building an integrated global food safety system.
The ASM urges Congress to provide additional funding for the FDA in FY 2015 because of the magnitude of its new responsibilities and the need for capacity in critical areas such as food safety.
FDA actions, based on scientific best practices, include consumer alerts and warnings; production guidances and tools for food safety; approval of new devices, diagnostics, treatments and vaccines; strategies to reduce drug resistant microbial pathogens; and safer veterinary medicines and animal foods. Recent FDA investigations of foodborne disease outbreaks, using laboratory tests to confirm, linked illnesses to rice, cheeses and prepackaged salad products. In the past year, FDA consumer alerts warned against oysters linked to norovirus illness, nonsterile pharmacological solutions,and carrot and beet juices possibly contaminated with Clostridium botulinum bacteria.
FDA has a strategic plan to strengthen regulatory science including, developing new tools, standards and methods to assess the safety, efficacy, quality and performance of FDA regulated products. FDA staff must access the best possible science and technology, as products move from premarket review to post market surveillance.
Science underlies all the activities of FDA’s seven product and research centers, as well as product regulatory actions. Public health often depends upon quick and accurate laboratory analyses. The Office of Regulatory Affairs (ORA) operates 13 high throughput field laboratories, situated across the United States and Puerto Rico. Lab results can support field investigations and regulatory decisions, including the thousands of ORA noncompliance citations issued each year to firms producing foods, medical devices, drugs, veterinary medicines, biologics, etc. Other FDA laboratories operated by the Agency’s Foods and Veterinary Medicine Program support the broad responsibilities of the Centers for Food Safety and Applied Nutrition (CFSAN) and Veterinary Medicine (CVM).
The ASM recommends that Congress fund the FDA at the highest level possible in FY 2015.
FDA scientists conduct research that advances the field of regulatory science, while protecting public health, including the following accomplishments in FY 2013:
- An FDA primate study found that FDA licensed acellular pertussis vaccines are effective in preventing whooping cough, but those vaccinated may still become infected with the causative pathogen, Bordetella pertussis bacteria and spread infection to others. Acellular vaccines using only portions of the bacteria replaced whole cell pertussis vaccines the 1990s. The study was initiated to help explain increasing whooping cough rates since the 1980s.
- A new FDA developed tool will improve security against intentional food contamination. The software program helps owners and operators of food facilities customize food defense plans to minimize risk in their specific facility. Content of the Food Defense Plan Builder tool is based on FDA guidance documents.
- A handheld FDA developed device to identify counterfeit antimalarial drugs, the Counterfeit Detection Device (CD-3), is being field tested in Ghana under a multiagency partnership. Counterfeit treatments complicate the already difficult global battle against a killer of more than 660,000 each year and whose causative pathogens are increasingly resistant to drugs. Scientists at the FDA’s Forensic Chemistry Center developed the easy to operate tool, which uses light of varying wavelengths to compare a product with an authentic sample.
Food items account for about 75 percent of consumer spending on FDA regulated products. The food industry in the United States contributes about 20 percent of the Gross National Product, employs about 14 million individuals and has ties to an additional 4 million jobs in related industries. FDA’s Center for Food Safety and Applied Nutrition (CFSAN) generally oversees all domestic and imported food except meat, poultry and frozen, dried and liquid eggs, which are regulated by the Department of Agriculture (USDA).
CFSAN regulates an estimated $417 billion worth of domestic food, $49 billion worth of imported foods and over $60 billion worth of cosmetics. Several industry and consumer trends have greatly increased CFSAN responsibilities, including globalization of the food supply and demand for imported foods, greater numbers of aging people vulnerable to foodborne illness, new food types and food production methods, emerging foodborne pathogens and growing concern over intentional food contamination.
CFSAN responsibility stretches from the point of US entry or processing to their point of sale. There are more than 377,000 FDA registered food facilities (approximately 154,000 domestic and 223,000 foreign) that manufacture, process, pack or store food consumed by humans or animals in the United States, as well as several thousand cosmetic manufacturers. Possibilities for food contamination are immeasurable and include every step from preharvest conditions to processing, packaging, transportation and preparation. CFSAN personnel routinely examine large numbers of food samples for a long list of specific contaminants that include toxins and microbial pathogens.
Imported foods give regulators fewer opportunities to oversee the food supply chain from farm to table. Food enters ports from about 150 different countries and accounts for about 15 percent of the food supply, including about 50 percent of fresh fruits and 20 percent of fresh vegetables we consume. In mid-2013, FDA proposed new rules that, for the first time, would (1) hold importers accountable for verifying their foreign suppliers implement adequate food safety practices and (2) raise the standards for third party auditors who inspect as contractors for food companies and importers. In December, the agency proposed a rule requiring larger food facilities, in the United States and abroad, to have a written food defense plan that identifies and resolves processing steps most vulnerable to intentional contamination.
To protect the food supply, FDA inspects facilities and collects samples, monitors imports, responds to adverse event reports and consumer complaints, reviews new food additives, releases regulations and guidelines to stakeholders, conducts lab research, educates food producers and the public and if necessary enforces rules and regulations by recalling or seizing faulty products. These activities demand up to date knowledge and technology utilized by CFSAN’s many scientific specialists, including microbiologists, molecular biologists, chemists, toxicologists, food technologists, pathologists, pharmacologists, nutritionists, epidemiologists, mathematicians, physicians and veterinarians.
FDA regularly builds strategic partnerships with other public health institutions. Many of its responsibilities are shared with other federal agencies like USDA and CDC. Because large amounts of food and cosmetics are imported, CFSAN works with international groups like the World Health Organization and sometimes directly with foreign governments. Products made and sold entirely within a state are regulated by that state, but FDA coordinates with state agriculture and health departments to resolve problems. CFSAN also collaborates with several academic institutions through its Centers of Excellence program, funding food safety and nutrition research at universities in four states.
Advances in Biomedicine
FDA scientists regularly evaluate biomedical products with considerable public health and economic value, divided among various research centers focused on drugs, medical devices or biologics like vaccines. Examples from the past year show the diversity and medical significance of FDA’s involvement in the biomedicine enterprise:
- A newly implemented FDA plan would phase out the use of medically important antimicrobials in food animals for food production purposes to address the public health crisis of rising drug resistance among microorganisms causing human infectious diseases.
- An approved rapid diagnostic is the first test that simultaneously detects tuberculosis bacteria and determines whether they contain genetic markers for resistance to rifampin, an important TB antibiotic. Test results are ready in about two hours versus traditional lab culture methods requiring one to three months.
- FDA allowed marketing of the first mass spectrometer system to automatically identify bacteria and yeasts pathogenic to humans. It can identify 193 different microorganisms and perform up to 192 different tests in a single series. Unlike many test systems that require abundant microbial growth pretesting, the new system uses a small amount of material with more rapid results.
- A new drug approved for chronic hepatitis C virus (HCV) infection is the first effective in treating certain types of HCV without co-administration of interferon. It is the third drug designated a “breakthrough therapy” to receive FDA approval. Breakthrough therapies are those shown by early clinical testing to have substantial advantage over available therapies for serious diseases. An estimated 3.2 million or more people are thought to be HCV infected.
- The first genotyping test for HCV infected patients identifies the genotype of HCV infecting a patient. It will help select the best treatment; HCV genotypes respond differently to available drugs. It is approved for patients with chronic infections, not as a screening or diagnostic test.
- FDA approved the first adjuvanted vaccine for H5N1 influenza (bird flu). Not intended for commercial availability, the vaccine will be included in the National Stockpile for distribution if H5N1 develops the capability to spread easily from human to human.
- A newly approved drug to treat HIV-1 infection contains an inhibitor that interferes with one of the enzymes necessary for HIV to multiply. FDA also approved the first rapid HIV test for simultaneous detection of HIV-1 p24 antigen and antibodies to both HIV-1 and HIV-2 in patient blood. Detection of the antigen permits earlier detection than possible with antibodies alone.
- Patients exposed to toxin secreted by botulism causing bacteria can now receive the first antitoxin that neutralizes all of the seven toxin serotypes known to cause botulism.
FDA regulatory actions in biomedicine serve the FDA’s partnership in several initiatives, including strategies to halt rising drug resistance among microbial pathogens, remedy the growing shortage of new therapeutic drugs or stimulate innovation in personalized medicine. FDA funding not only subsidizes its own invaluable work, but it also supports the FDA’s collaborations with other public health agencies at the federal, state and local levels.