Foreign pharmaceuticals, active pharmaceutical ingredients (APIs), and other regulated drug products are more accessible than ever before. The internet fosters direct transactions between consumers and foreign retailers. Many physicians and practitioners purchase products from foreign sources in their routine practice. But certain drug products may not be “approved” for sale in the United States market. FDA prohibits sale of unapproved drugs by foreign entities in the United States, paying close attention to the manner in which foreign entities offer those products for sale. To preserve access to crucial drugs unavailable domestically, patients should fully understand the limits and use of FDA’s personal importation policies. Those policies exist by administrative fiat. Because most such imports remain “unapproved” FDA drugs, the agency can terminate access at any point if a product fails to comply.
Imported products are usually subject to greater FDA scrutiny. Unlike domestically-sourced products, which enter the market directly, all foreign products must clear customs. In theory, FDA or CBP (Customs and Border Protection) should review all products offered for entry. CBP designates items like drugs, cosmetics, foods, dietary supplements, and medical devices for FDA review. Even small UPS packages will proceed through CBP. Therefore, imported products are more likely to face FDA pre-market review than domestic products.
FDA will examine many packages to determine compliance with the federal laws and regulations. Those import inspections frequently result in detentions, import holds, or import alerts. Certain import alerts trigger close scrutiny of all products offered for entry by a company until the alert (import hold, or DWPE) is removed. Thus, FDA intervention can prevent or delay patient care dependent on foreign drugs, and create substantial economic losses at the distributor/importer level.
Companies, pharmacies, physicians, and consumers should know the legal status of drug products before purchase. Some foreign outfits will enter transactions with United States consumers without regard to the lawful status of a product. In 2001, FDA’s Senior Associate Commissioner for Policy, Planning, and Legislation testified before the House Committee on Energy and Commerce, Subcommittee on Oversight and Investigations. He explained that FDA lacked resources to police effectively the direct-to-consumer market. Because of limited resources, FDA cannot hope to identify, process, detain, or even inspect every drug shipment offered for entry. Despite greater funding in recent years, those limitations still apply at many ports. Thus, parcels that FDA cannot review are eventually released and sent to customer addressees, “even though the products contained in these parcels may appear to violate the FD&C Act and may pose a health risk to consumers.” See Testimony of William K. Hubbard, June 7, 2001.
Whether you are a distributor, importer, physician, patient, or foreign manufacturer, successful importation in the past does not guarantee future success. Because FDA cannot police every product offered for entry, many non-compliant products will pass unnoticed, sometimes for years before FDA acts. Only products imported in compliance with the FDCA will remain available over the long-term. Practitioners and businesses that rely on unapproved foreign drugs risk FDA enforcement or cessation of business if FDA later takes issue with the imported product.
In response to an increasing number of imports, the FDA enacted policy guidelines concerning the Coverage of Personal Importations. Note that this policy is entirely discretionary, meaning that at any time and for any reason FDA can prevent the import. In related publications, the FDA explained that its policy “does not specify that a U.S. citizen may import an unapproved drug with a prescription from a U.S. licensed physician, or that a foreign citizen may import an unapproved new drug only with a foreign prescription.” Put simply, “personal” imports of unapproved drugs still violate federal law. FDA has simply chosen not to act when certain conditions are satisfied. FDA’s Guidance explains:
In deciding whether to exercise discretion to allow personal shipments of drugs or devices, FDA personnel may consider a more permissive policy in the following situations:
(1) when the intended use is appropriately identified, such use is not for treatment of a serious condition, and the product is not known to represent a significant health risk; and
(2) when a) the intended use is unapproved and for a serious condition for which effective treatment may not be available domestically either through commercial or clinical means; b) there is no known commercialization or promotion to persons residing in the U.S. by those involved in the distribution of the product at issue; c) the product is considered not to represent an unreasonable risk; and d) the individual seeking to import the product affirms in writing that it is for the patient’s own use (generally not more than 3 month supply)and provides the name and address of the doctor licensed in the U.S. responsible for his or her treatment with the product, or provides evidence that the product is for the continuation of a treatment begun in a foreign country.
See FDA Regulatory Procedures Manual, Chapter 9-2, “Coverage of Personal Importations.”
Practitioners should note paragraph (2)(b), which prohibits reliance on the personal import policy when the drug is “commercialized” or “promoted” to “persons residing in the U.S. by those involved in the distribution of the product at issue.” In other words, if the product is marketed to United States consumers (through the internet or otherwise), the drug product falls outside the personal use import policy. A product is “commercialized” when agents of the foreign manufacturer, distributor, or domestic practitioners “sell,” “market,” or “promote” the drug, or when internet advertisements target U.S. consumers directly.
The FDA designed its personal importation policy to permit transportation of drugs into the U.S. for uninterrupted treatment initiated abroad, or to allow patient access to ostensibly harmless drug products on a very limited basis. Bulk imports of drugs, commercialized drug products, or products that compete directly with “approved” FDA drugs will continue to face FDA enforcement despite the agency’s personal importation policy.
Purchasers should seek expert consultation concerning the application of FDA’s personal importation policy for specific drugs and indications. Patients should determine whether drugs they need are lawful FDA products, or unlawful drugs ushered through the FDA’s personal import policy. If the latter, continued treatment will depend on FDA discretion, making reliable access precarious.
Treating physicians and patients can take steps immediately to maintain access. The FDA’s personal import policy largely follows the spirit and text of FDA’s “Expanded Access” regulations, which create pathways to experimental drug access for terminally ill patients. If use of the medication presently satisfies most of the personal import criteria, then a patient might also satisfy the criteria for an experimental IND in 21 CFR 312.310. Treating physicians may also satisfy the criteria in Section 312.315 (or even 312.320) for larger treatment protocols. Foreign entities can also take measures to ensure that products are not promoted or commercialized in the United States. Physicians and practitioners should ensure that provision of the drug product remains within the traditional “practice of medicine” without nexus to commercial channels.
A judicious regard for the limits of FDA’s policies governing unapproved imports at the outset can avoid costly and burdensome inspections, investigations, and/or FDA enforcement action.