Why This Is a Challenge
HHS, through the Food and Drug Administration (FDA), must ensure the safety, efficacy, and security of our Nation's food supply, drugs, biologics, and medical devices. FDA is also responsible for regulating tobacco products. Areas of particularly high risk include food safety, drug compounding, a complex drug supply chain, and improper marketing activities.
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Key Components of the Challenge
Food Safety. Foodborne illnesses, such as those caused by Salmonella, Listeria monocytogenes, and E. coli, pose a continuing public health threat. Oversight is complicated by the immense diversity of the global food supply: 20 percent of our vegetables come from abroad, as does 50 percent of our fresh fruit, and more than 80 percent of our seafood.1 When a problem with the U.S. food supply is identified, FDA must ensure that the problem is addressed using its various administrative tools and enforcement authorities. After reviewing 30 recalls selected on the basis of their risk factor, OIG recently alerted FDA that consumers remained at risk of illness or death for several weeks after FDA was aware of a potentially hazardous food in the supply chain.
Drug Compounding. The potential danger of improperly compounded drugs drew national attention in 2012 when drug injections meant to be sterile were contaminated during the compounding process and resulted in a deadly fungal meningitis outbreak. Compounded drugs are not subject to FDA's premarket approval process, in which FDA evaluates the safety and efficacy of conventionally-manufactured drugs. FDA continues to identify serious problems at facilities that compound drugs, the vast majority of which do not register with the FDA.2 (For information on rising costs and potential fraud involving compounded drugs, see TMC #6.)
Complex Drug Supply Chain. The drug supply chain is growing increasingly complex, not only domestically but globally. This makes it difficult to track products to their sources in case of a recall and complicates FDA's task of ensuring the integrity of these products. Multiple manufacturers may be involved in the various stages of production. Currently, about 40 percent of prescription drugs sold in the United States and 80 percent of active ingredients used in drugs are made in other countries.3 Once drugs are produced, multiple parties may distribute or repackage the finished product. Drugs from unapproved sources can also enter the U.S. drug supply chain. Disruptions in the supply chain can lead to problems with patient access to needed prescription drugs.4
Improper Marketing Activities. FDA approves the marketing of drugs, biologics, and medical devices for specific uses after determining that the products are safe and effective for those uses. Once approved, qualified medical practitioners may prescribe them for any use, including uses not approved by the FDA. However, individuals and manufacturers are prohibited from marketing products for unapproved uses. In general, the Federal health care programs do not cover unapproved products. Improper marketing activities can 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 TMC #6.)
Progress in Addressing the Challenge
Food Safety. FDA continues to implement its enhanced food-safety authorities statutorily granted in 2011 by the Food Safety Modernization Act. In 2015 and 2016, the Agency finalized rules on preventative controls for human food, current good manufacturing practices and preventative controls for animal food, produce safety, accredited third-party certification, sanitary transportation of human and animal food, protection against intentional adulteration, and the foreign supplier verification program. FDA's food scientists have also worked to further develop and broaden the use of whole genome sequencing technologies to better differentiate between organisms and strains to identify and prevent foodborne illnesses. FDA continues collaboration with State regulatory and public health partners to establish an integrated national food safety system and has initiated new efforts to incorporate produce safety. Additionally, as part of FDA's effort to leverage the comparable food safety oversight conducted by foreign partners, FDA entered into food safety systems recognition agreements with New Zealand in December 2012 and Canada in May 2016.
Drug Compounding. In 2013, the Compounding Quality Act clarified and amended FDA's authority to oversee compounding, including providing a new pathway for compounders to register with FDA as outsourcing facilities. Outsourcing facilities that compound drugs in accordance with the conditions set forth in the Compounding Quality Act are eligible for exemptions from certain FDA requirements, but are held to manufacturing quality standards similar to those applicable to conventional drug manufacturers. FDA continues to work to fully implement the Compounding Quality Act, and the Agency has issued numerous policy and guidance documents applicable to outsourcing facilities and other compounders. FDA also 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.
Complex Drug Supply Chain. The Drug Supply Chain Security Act created the basis for building an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States, whether they originate in this country or not. FDA has issued guidance to establish initial standards for the interoperable exchange of product tracing information and also created a publicly available database of authorized wholesale distributors of traceable prescription drugs. OIG is reviewing wholesale distributors' and dispensers' early experiences in exchanging product tracing information.
Improper Marketing Activities. To protect patients and reduce the waste of Federal health care program money, OIG, FDA, and their law enforcement partners have pursued numerous enforcement actions against manufacturers for improperly marketing drugs, biologics, and devices. In addition, FDA has engaged in both outreach and enforcement actions on unapproved drugs and devices, including unapproved products from foreign sources. FDA has also undertaken efforts to warn consumers, medical practitioners, and others about the medical risks associated with importing unapproved drugs. FDA, OIG, and their law enforcement partners continue to investigate and prosecute physicians and suppliers that distribute unapproved drugs and devices. FDA collaborates with international partners and has introduced improved border screening to enhance oversight of imported products.
What Needs To Be Done
Implementation. FDA must continue taking steps to fully implement its statutory authorities and develop robust policies and procedures to ensure that problems with the Nation's food supply are addressed in a timely manner. OIG has recommended that FDA remedy identified weaknesses in recall procedures and better ensure that recalls are promptly initiated, monitored, and closed out. 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. FDA must also continue to implement its new authorities in tracking drugs through the supply chain.
Oversight. FDA must ensure that drug supply chain partners comply with product tracing requirements. FDA has twice delayed its enforcement of certain product tracing requirements for wholesale distributors and dispensers due to their requests for additional time to implement product tracing requirements. FDA must also continue combating improper marketing practices and importation of unapproved drugs for commercial distribution in the United States. OIG, in cooperation with the Department of Justice 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.
OIG will continue monitoring the changing legal landscape, legislative developments, and FDA's oversight of food, drugs (both prescription and over-the-counter), biologics, dietary supplements, medical devices, and tobacco, and adjust priorities as needed.
Key OIG Resources
- OIG Report, "Early Alert: The Food and Drug Administration Does Not Have an Efficient and Effective Food Recall Initiation Process," June 2016.
- OIG Report, "High Part D Spending on Opioids and Substantial Growth in Compounded Drugs Raise Concerns," July 2016.
- OIG Report, "High-Risk Compounded Sterile Preparations and Outsourcing by Hospitals That Use Them," April 2013.
- OIG Report, "FDA is Issuing More Postmarketing Requirements, but Challenges with Oversight Persist," July 2016.
- https://www.fda.gov/InternationalPrograms/FDABeyondOurBordersForeignOffices/ (accessed October 26, 2016).
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