USA Law and Practice Contributed by: Daniel Kracov, David Marsh and Alice Ho, Arnold & Porter
• subject to down-classification via the de novo sub- mission process; or • eligible for full approval via a pre-market approval (PMA) application. Although the FDA has traditionally been given signifi- cant independence as an agency, and the Commis- sioner is confirmed by the Senate, the FDA is part of the Department of Health and Human Services (HHS). Under the current US administration, HHS is exercis- ing much greater control over the policy priorities and decisions of the agency. The government agencies touching on pricing and reimbursement vary, depending upon the payor pro- gramme, and include the Centers for Medicare & Medicaid Services (CMS) (also part of the HHS), the Veterans Health Administration, and state Medicaid agencies. In addition, the HHS Office of Inspector General oversees laws governing fraud and abuse in the sale of biomedical products and healthcare ser- vices. The Federal Trade Commission (FTC), an inde- pendent agency, regulates the advertising of non-pre- scription drugs and non-restricted medical devices. 1.2 Challenging Decisions of Regulatory Bodies Agency decisions may be challenged either informal- ly (via guidance-driven processes governing dispute resolution) or via more formal regulatory processes specified under FDA regulations. In addition, a gen- eral-purpose vehicle for bringing issues before the agency is the FDA citizen petition, which allows the petitioner to bring a request before the FDA and initi- ate a public docket in which comments can be lodged. The FDA also maintains ombuds in the various centres where products are reviewed, whose role is intended to facilitate the resolution of disputes. Although pro- cedures for dispute resolution vary, depending on the specific statutory provisions at issue and the FDA centre responsible for the category of products, such processes generally follow Administrative Procedure Act (APA) standards for due process and creating an administrative record. Once administrative processes are exhausted, parties with appropriate standing may challenge FDA deci- sions in court under the APA. Although administrative
processes vary by category, APA legal challenges typ- ically involve a demonstration that an agency action was arbitrary or capricious or otherwise not in accord- ance with governing law. 1.3 Categories of Pharmaceuticals and Medical Devices Although the default status for drug approvals is tech- nically OTC (ie, non-prescription, over-the-counter), most initial drug approvals specify that new drug products are subject to prescription drug controls. Prescription drugs must be labelled as such and are subject to physician prescribing, pharmacy dispens- ing, and substitution controls under state law. However, it is possible to seek an initial FDA approv- al for the sale of a drug product OTC or to seek to “switch” a prescription product to OTC status by dem- onstrating that the condition can be self-diagnosed and treated in accordance with labelling. Moreover, throughout the decades, the FDA has also developed OTC monographs that permit the marketing – without approval – of certain OTC drugs that meet the specific terms (eg, ingredients, dosing, and directions for use) for that class of drug and associated labelling under the relevant monograph. Such drugs remain subject to establishment registration, listing, labelling and current Good Manufacturing Practice (cGMP) require- ments. In 2020, legislation liberalised the processes for amending OTC monographs and this could help reinvigorate OTC product development in the USA. Additionally, the FDA has issued a final rule that per- mits OTC drugs with an “additional condition for non- prescription use” (ACNU). The purpose of this is to increase options for the development and marketing of safe and effective non-prescription drug products via the use of tools (such as digital apps) that support accurate patient self-diagnosis and treatment. Medical devices may also be assigned to non-restrict- ed (including OTC) or restricted status, depending on their classification and the FDA’s determination as to appropriate status under clearance and approval pro- cesses.
402 CHAMBERS.COM
Powered by FlippingBook