USA Law and Practice Contributed by: Daniel Kracov, David Marsh and Alice Ho, Arnold & Porter
a voucher include enhanced communications and rolling review to help facilitate a greatly abbreviated review time. Each of the above-mentioned programmes provides various benefits that may accelerate approval, ranging from additional agency input to rapid review. 4.2 Regulatory Reliance If a company has already obtained authorisations (whether product-related or establishment-related) from internationally recognised jurisdictions, the FDA does not expedite the issuance of its own authori- sations. However, there are frequent interactions between the FDA and other jurisdictions – in particu- lar, Canada, the UK, and the EU – concerning issues such as establishment inspection priorities and prod- uct safety. 5. Manufacturing of Pharmaceuticals and Medical Devices 5.1 Requirement for Authorisation for Manufacturing Plants In general, manufacturing plants are not subject to a separate authorisation from the related product approvals – although they must be registered with the FDA (and the products produced at the facility must be listed as associated with the establishment). Moreover, in most cases, the FDA will review extensive manufacturing and controls information in the prod- uct application and conduct a pre-approval inspec- tion of the facility before approving a drug or high-risk device. Such establishments are also subject to both routine (typically every two years) and for-cause (eg, in response to a product defect and recall) inspections. 6. Distribution of Pharmaceuticals and Medical Devices 6.1 Wholesale of Pharmaceuticals and Medical Devices In general, wholesale activities are subject to licens- ing requirements at the state level and registration as distributors at the federal level. The requirements and length of such licences vary by state.
The FDA may inspect any facility holding drugs for shipments – although state inspection activities and fees vary greatly. Significant additional requirements administered by the DEA and states apply to whole- sale trade in controlled substances. The authorisation to trade in pharmaceuticals varies greatly by state; however, most pharmaceutical dis- tributors must hold a state licence. Such requirements often do not apply to entities that are not physically handling drug products. 6.2 Different Classifications Applicable to Pharmaceuticals Drugs may be either prescription – ie, as defined under state law, generally subject to prescription by a designated healthcare practitioner and dispensing by a licensed pharmacist – or OTC (permitting sale without intervention by a healthcare practitioner or pharmacist). Certain products (eg, pseudoephedrine) must be kept behind the pharmacy counter, owing to specific statutory requirements. In addition, when an otherwise commercially available drug is in shortage, compounding pharmacies and outsourcing facilities may produce and sell the drug in response to physi- cian prescriptions. 7. Import and Export of Pharmaceuticals and Medical Devices 7.1 Governing Law and Relevant Enforcement Bodies The FD&C Act and general import and export admin- istration laws govern the import/export of pharma- ceuticals and medical devices. Typically, imported medicines and medical devices must be subject to an approval or clearance (if applicable) in the USA. Only the original manufacturer of a drug may re- import a drug product back into the USA, subject to limited programmes – aimed at demonstrating how the importation of certain drugs can be accomplished in an attempt to reduce prices – that have not been approved or implemented to date. The importation of even an identical drug produced at a facility that is not inspected in the course of the US approval would be considered unlawful. Limited exceptions are per- mitted for individuals to engage in personal, physical
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