Many healthcare companies, practitioners, and patients, think that they can get away with bringing unapproved drugs into the U.S. and that the FDA Personal Importation Policy will cover them.
That is far from the truth. FDA’s personal importation policy for drugs is very limited.
FDA’s Stated Limitations on the Personal Importation Policy
On its webpage, Information on Importation of Drugs (“Importation Page”), FDA notes that the federal Food, Drug & Cosmetic Act (the “FDCA”)
prohibits the interstate shipment (which includes importation) of unapproved new drugs. Thus, the importation of drugs that lack FDA approval, whether for personal use or otherwise, violates the Act. Unapproved new drugs are any drugs, including foreign-made versions of U.S. approved drugs, that have not been manufactured in accordance with and pursuant to an FDA approval. Under the Act, FDA may refuse admission to any drug that "appears" to be unapproved, placing the burden on the importer to prove that the drug sought to be imported is in fact approved by FDA.
FDA is very clear about its authority here. Also, FDA makes clear that the drugs are subject to an NDA, or are considered illegal:
Absent evidence that the specific drugs sought to be imported from a foreign country/area have been manufactured pursuant to an approved new drug application, in the manufacturing facility permitted under the application, such drugs would appear to be unapproved new drugs subject to FDA enforcement action.
On its webpage, Personal Importation, FDA warns:
In most circumstances, it is illegal for individuals to import drugs or devices into the United States for personal use because these products purchased from other countries often have not been approved by FDA for use and sale in the United States. For example, a drug approved for use in another country but not approved by FDA would be considered an unapproved drug in the United States and, therefore, illegal to import.
FDA has guidance for personal importation of drug or device products in its Personal Importation Policy FAQs and Regulatory Procedures Manual. Here, FDA explains that personal importation might be allowed if the following are true (we’ve added bold for emphasis).
- Product is not for treatment of a serious condition and there is no known significant health risk; and
- Product is for the treatment of a serious condition (Prescription Drug Products):
- The product is for a serious condition for which effective treatment may not be available domestically either through commercial or clinical means.
- There is no known commercialization or promotion of the product to persons residing in the U.S.
- The product does not represent an unreasonable risk.
- The consumer affirms in writing that the product is for personal use.
- The quantity is generally not more than a three-month supply and either:
a. Provide the name and address of the doctor licensed in the U.S. responsible for your treatment with the product, or
b. Provide evidence that the product is for the continuation of a treatment begun in a foreign country.
If the product is to treat something like diabetes or cancer, then among the criteria is that “effective treatment may not be available domestically either through commercial or clinical means.” This really covers the bases. FDA includes experimental drugs that are in clinical trials.
Another point to consider is that if the company manufacturing or supplying these drugs to U.S. customers makes claims, on their website, about treating or mitigating cancer or diabetes, for example, or improving efficacy of cancer or diabetes treatment, then that could be considered “known commercialization” to U.S. residents.
The point is that the personal importation policy can’t be relied on here as a regulatory route to U.S. sales.
Why the Personal Importation Policy Exists
The personal importation exemption is designed so consumers can finish protocols or access specific products they might have started while abroad.
The three months’ supply portion of the rule severely limits consumer access.
It’s not the consumer, though, that these limitations are targeting. It’s overseas companies that would try to use the Personal Importation Policy as an end run around the new drug application.
To emphasize the point that FDA will likely take strong and swift action, FDA notes on its Importation Page that the Personal Importation Policy:
Is not, however, a license for individuals to import unapproved (and therefore illegal) drugs for personal use into the U.S., and even if all the factors noted in the guidance are present, the drugs remain illegal and FDA may decide that such drugs should be refused entry or seized.
As well, FDA notes that its statements in the Personal Importation Policy guidance “are intended only to provide operating guidance for FDA personnel and are not intended to create or confer any rights, privileges, or benefits on or for any private person.”
FDA retains enforcement discretion.
Those two little words—enforcement and discretion—leave a wide swathe or regulatory intervention in FDA hands.
There’s a saying that you can’t fool Mother Nature—and you can’t fool Father FDA, either. The best thing to do is to consult an FDA regulatory attorney who can assess your FDA exposure and craft a wise legal strategy that accounts for the risks.