Inspector General’s FDA Challenges
An HHS inspector general’s (IG) report on the top management and performance challenges facing the agency says that FDA’s challenges include drug compounding, the complex drug supply chain, improper marketing activities, and food safety. The report describes each challenge, the progress made in addressing it, and what remains to be done.
Drug Compounding. The IG notes that compounded drugs are not subject to FDA’s premarket approval process in which the agency 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 FDA,” it says. The report says that the 2013 Compounding Quality Act clarified and amended the agency’s authority to oversee compounding, including providing a new pathway for compounders to register with FDA as outsourcing facilities. The report says the agency continues to work to fully implement the new law and has issued numerous policy and guidance documents applicable to outsourcing facilities and other compounders. It 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 growing complexity of the drug supply chain not just domestically but globally makes it difficult to track products to their sources in case of a recall and complicates FDA’s task of ensuring the integrity of those products, the IG says. Multiple companies may be involved in the various stages of drug production, the report says, and in distributing and repackaging the finished products. Drugs from unapproved sources can also enter the U.S. supply chain, and supply chain disruptions can lead to problems with patient access to needed prescription drugs. The report says 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 U.S., whatever the country of origination. FDA has issued guidance to establish initial standards for the interoperable exchange of product tracing information and has created a publicly available database of authorized wholesale distributors of traceable prescription drugs.
Improper Marketing Activities. Individuals and manufacturers are prohibited from marketing products for unapproved uses, the IG writes, and improper marketing activities can put patients at risk of receiving inappropriate or harmful care and can lead to fraudulent claims for payment from federal healthcare programs. FDA, OIG, and their law enforcement partners have pursued numerous enforcement actions against manufacturers for improperly marketing drugs, biologics, and medical devices, the report says. And FDA has engaged in both outreach and enforcement actions on unapproved drugs and devices, including unapproved products from foreign sources. It also has taken steps to warn consumers, medical practitioners, and others about the medical risks associates with importing unapproved drugs.
FDA must take steps, the IG says, to fully implement its statutory 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. It also must continue to implement its new authorities in tracking drugs through the supply chain.
The report also calls on the agency to 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 tracking requirements,” the report says. It further says that FDA must continue combating improper marketing practices and importation of unapproved drugs for commercial distribution in the U.S.