USA Law and Practice Contributed by: Daniel Kracov, David Marsh and Alice Ho, Arnold & Porter
1.3 Different Categories of Pharmaceuticals and Medical Devices Although the default status for drug approvals is technically OTC (ie, non-prescription), most ini- tial drug approvals specify that new drug prod- ucts are subject to prescription drug controls. Prescription drugs must be labelled as such and are subject to physician prescribing, pharmacy dispensing, and substitution controls under state law. However, it is possible to seek an initial FDA approval for the sale of a drug product OTC or to seek to “switch” prescription product to OTC sta- tus by demonstrating 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 label- ling under the relevant monograph. Such drugs remain subject to establishment registration, list- ing, labelling and current Good Manufacturing Practice (cGMP) requirements. Recent legisla- tion 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 permits OTC drugs with an “additional condition for non-prescription use” (ACNU). The purpose of this is to increase options for the develop- ment and marketing of safe and effective non- prescription drug products via the use of tools (such as digital apps) that support patient self- diagnosis and treatment. Medical devices may also be assigned to non- restricted (including OTC) or restricted status, depending on their classification and the FDA’s
HHS Office of Inspector General oversees laws governing fraud and abuse in the sale of bio- medical products and healthcare services. The Federal Trade Commission (FTC), an independ- ent agency, regulates the advertising of non- prescription drugs and non-restricted medical devices. 1.2 Challenging Decisions of Regulatory Bodies That Enforce Pharmaceuticals and Medical Devices Regulation Agency decisions may be challenged either informally (via guidance-driven processes gov- erning dispute resolution) or via more formal regulatory processes specified under FDA regu- lations. In addition, a general-purpose vehicle for bringing issues before the agency is the FDA citi- zen petition, which allows the petitioner to bring a request before the FDA and initiate a public docket in which comments can be lodged. The FDA also maintains ombudsmen in the various centres where products are reviewed, whose role is intended to facilitate the resolution of disputes. Although procedures for dispute reso- lution vary, depending on the specific statutory provisions at issue and the FDA centre responsi- ble 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 decisions in court under the APA. Although administrative processes vary by category, APA legal challenges typically involve a demonstra- tion that an agency action was arbitrary or capri- cious or otherwise not in accordance with gov- erning law.
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