Management Challenge 10: Ensuring the Safety of Food, Drugs, and Medical Devices
Why This Is a Challenge
The Department, through FDA, must ensure the safety, efficacy, and security of drugs, biologics, medical devices, dietary supplements, tobacco, feed, and much of our Nation's food supply. However, weaknesses exist. Areas of particularly high risk include drug compounding; the global supply chain; food safety; illegal marketing and promotion; and dietary supplements.
Compounded Drugs. Compounded drugs are produced outside of FDA's regulatory process designed to ensure the safety and efficacy of commercially manufactured drugs. The potential danger of compounded drugs drew national attention in 2012, when contaminated compounded sterile drug injections caused a fungal meningitis outbreak. The widespread use of compounded products in health care and FDA's limited ability to effectively oversee compounding entities, which number in the thousands and, generally, do not register with FDA, are causes for concern.
Imported Food and Drugs. Foreign sources account for about 40 percent of the drugs, 50 percent of the medical devices, 15 percent of the food, 85 percent of the seafood, and 50 percent of the fresh fruit used by Americans. The global nature and complexity of this supply chain complicates FDA's task of ensuring safety.
Food Facilities. Food-borne illnesses, such as those caused by salmonella, listeria and E. coli, pose a continuing public health threat. Despite legal requirements for food facilities to investigate and report adulteration and other serious food-safety concerns, food facilities' failures to comply impede the Department's ability to ensure the safety of the Nation's food supply.
Off-label Promotion and Kickbacks. Manufacturers of drugs, biologics, and medical devices gain approval for sale of their products for specific uses once FDA determines that the products are safe and effective for those uses. Once approved for sale, qualified medical providers may prescribe them for any use, including unapproved uses, commonly called "off-label uses." However, manufacturers are prohibited from promoting products for off-label uses. Manufacturers are also prohibited from paying kickbacks to physicians or other health care providers to promote the use of their drug, biologic, or medical device. OIG continues to identify illegal off-label promotion and kickbacks that put patients at risk of receiving inappropriate or harmful care and lead to fraudulent claims for payment from federal health care programs. (For more information on drug diversion and utilization of prescription drugs, see Management Challenge 5).
Dietary Supplements. Dietary supplement manufacturers use structure/function claims to persuade consumers to purchase and use their products. Structure/function claims can describe the effect of a dietary supplement on the structure and function of human bodies but may not claim to prevent, treat, mitigate, cure, or diagnose a disease. Reliable evidence must substantiate these claims as truthful and not misleading, but manufacturers are not required to submit the substantiation to FDA prior to marketing their products, and FDA has only voluntary standards for submission. Those substantiation documents submitted often do not reflect reliable evidence.
Progress in Addressing the Challenge
In 2013, the Drug Quality and Security Act (DQSA), amended the Federal Food, Drug, and Cosmetic Act to enhance FDA's authority to oversee compounding, including by providing a new pathway for compounders to register as "outsourcing facilities" to legally compound drugs. The Department continues to work to fully implement DQSA, and FDA has issued numerous policy and guidance documents and increased its inspection and enforcement efforts. FDA continues to inspect compounding facilities; oversee recalls of compounded drugs for contamination or lack of sterility assurance; and issue warning letters to compounders that violate the law.
To address risks associated with imported drugs, FDA has engaged in both outreach and enforcement actions. FDA has undertaken significant efforts to warn consumers, medical practitioners, and others about the risks associated with illegally buying drugs from foreign sources. In addition, FDA has continued to work with OIG and other law enforcement partners to investigate and prosecute physicians and drug suppliers that import unapproved drugs, most notably misbranded, unapproved chemotherapy drugs. Physicians who bill Medicare or Medicaid for such unapproved drugs can be subject to criminal liability under the False Claims Act and excluded from participating in federal health care programs. FDA continues to cooperate with international partners and has introduced improved border screening to enhance oversight of imported products.
FDA continues to implement its enhanced food-safety authorities statutorily granted in 2011 by the Food Safety Modernization Act (FSMA). In September 2015, FDA promulgated new food safety rules that will require U.S. manufacturers of both human and animal foods to make detailed plans to identify and prevent contamination risks in their production facilities. FDA's food scientists have helped improve genome sequencing technologies to better detect and prevent foodborne illnesses, and FDA continues to work on improving nutrition and calorie labeling to better inform consumers.
OIG and its law enforcement partners have pursued numerous enforcement actions against drug, biologic, and device manufacturers for illegally promoting their products in ways that could harm patients and waste federal health care program money.
FDA endeavors to continue to make progress in addressing OIG recommendations to improve oversight of dietary supplements. In response to an OIG recommendation, FDA stated that it would consider seeking enhanced authority to review substantiation for structure/function claims.
What Needs To Be Done
The Department and FDA must continue issuing rules and guidance documents to fully implement FSMA, and DQSA, as well as the July 2012 Food and Drug Administration Safety and Innovation Act (FDASIA). FDA must continue to implement its new authorities to enhance oversight of drug compounders and better ensure the safety of compounded products, including by inspecting drug compounders and pursuing regulatory action when deficiencies are identified. OIG plans continued oversight of FDA's inspection of food facilities and monitoring of food recalls. OIG continues to recommend that FDA remedy identified weaknesses in its inspections and recall procedures and better ensure that states properly conduct contracted food facility inspections. The Department also must continue combating off-label promotion and illegal importation of unapproved drugs. OIG, in cooperation with DOJ and other law enforcement partners, will continue to employ investigative and enforcement authorities to protect federal health care programs and beneficiaries from these potentially dangerous products.
Key OIG Resources
- OIG Report, Penetration Test of the Food and Drug Administration's Computer Network, October 2014
- OIG Report, High-Risk Compounded Sterile Preparations and Outsourcing by Hospitals That Use Them, April 2013
- OIG Report, FDA Lacks Comprehensive Data To Determine Whether Risk Evaluation and Mitigation Strategies Improve Drug Safety, February 2013
- OIG Report, Dietary Supplements: Structure/Function Claims Fail to Meet Federal Requirements, October 2012
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