Legal and Risk Management Concerns Relating to the Use of non-FDA Approved Drugs in the Practice of Psychiatry

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The Personal Use Exception: Limitations and Problems

As stated above, the 1938 Act provides the basis for the FDA's statutory authority to regulate the importation of drugs into the United States. Pursuant to this authority, unapproved drugs may not be imported without prior Agency permission. However, there is a great deal of attention being focused on the FDA's policy granting a limited "personal use" exception for unapproved new drugs or devices imported by mail or in personal luggage and intended solely for that individual's use.⁷ The FDA's Regulatory Procedures Manual (RPM), an internal Agency document which provides guidance to its field personnel, sets out enforcement priorities in relation to personal importation of unapproved drugs.⁸ The personal use policy balances two conflicting principles by recognizing, first, that drugs, which have not been proven safe and effective should not be consumed by the public and, second, that certain individuals may have overriding needs to have access to unapproved drugs.

The intent of the personal use importation policy is to save FDA resources and, generally, to permit limited entry, through the exercise of enforcement discretion, of medical products not otherwise available in the United States. The effect of the personal use policy is that enforcement resources will focus on seizing imported products that are apparently intended for the commercial market, are fraudulent products, and those that impose an unreasonable health risk. The RPM states that FDA personnel may use discretion when deciding whether to allow personal importation of drugs or devices 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; or 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 United States 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 a three month supply) and provides the name and address of the doctor licensed in the United States 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."⁹

This does not automatically mean that any and all substances may be imported with impunity. The FDA's RPM policy is not a license for individuals to import unapproved drugs for personal use into the United States. Even assuming all the above factors are present the drugs themselves remain illegal and are subject to seizure. The decision whether to permit an individual to import the drugs remains within the discretion of the FDA. A person does not have any vested right, interest or entitlement to the use of a particular medication that has not been approved by the FDA.¹⁰ The RPM specifies that "the statements in this chapter 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."¹¹ No one should assume that, because a FDA policy exists to address the limited personal use importation of non-approved drugs, such a policy constitutes an exception to the law. It is a violation of the law for a physician to import the drug for distribution to a patient. If the FDA refuses admission of a drug, there is no statutory right to judicial review. The courts have held that Congress left the decision to the FDA's discretion. In nearly all cases the courts have upheld the FDA's decision. The FDA has successfully seized unapproved new drugs that were being transported across the United States, even if their final destination was a foreign country. Further, the current federal law makes it unlawful, without proof of intent or demonstration of actual injury or deception, to market drugs that the agency has not approved.¹²

Individuals involved in importation of unapproved drugs are at risk of violating state and local drug enforcement laws as well as being in violation of the federal laws and thus all at risk for criminal charges. Additionally, importing, possessing, distributing, and/or prescribing unapproved drugs may be a violation of a state's medical practice act. Such a violation on the part of a physician could result in loss of DEA Certification, discipline by the medical licensing board, and/or loss of a medical license. Also, allegations made in relation to such unlawful acts would likely be excluded from coverage under a professional liability insurance policy should a claim arise against an insured physician under these circumstances. Thus a physician may well find himself or herself in the position of having to personally pay to defend and indemnify against such a claim. A psychiatrist should know the laws and regulations in the state(s) where he or she is licensed to practice before taking the risk of treating with unapproved drugs. A psychiatrist should seek the advice of personal counsel as to the impact of federal laws, state and local drug enforcement laws and state licensing laws in all cases where he or she is considering the use of unapproved drugs, other than in compliance with FDA authorized investigational new drug protocols (discussed below).

Individuals who plan to import unapproved drugs under the personal use exception need to understand that they may be allowed personal-use importation on one occasion but not on a subsequent occasion. This presents a real risk of disruption of supply of unapproved drugs for any patient relying on them. Sudden withdrawal from some medications can cause severe reactions. Additionally, drugs that have not been subject to the FDA approval process may pose other health risks. For example, the person importing unapproved drugs may not know if they were manufactured using appropriate quality control methods. Drugs may not be properly labeled, may contain unsafe ingredients, and may not have adequate warnings or information about proper use or possible side effects. Patients should also understand that possession of some medications without a prescription from a physician licensed in the United States might violate state and local drug enforcement laws.

Current information on Import Alerts and Import Detention Information can be obtained from the FDA's Internet web site. The address is http://www.fda.gov. Questions about the import policies and procedures should be sent, in writing, to: Food and Drug Administration, Division of Import Operations and Policy, HFC-170, 5600 Fishers Lane, Rockville, MD 20857-1706

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