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

Disclaimer: This article is meant to be an overview of a subject that is of interest to many psychiatrists and their patients. It is by no means an exhaustive treatment of the subject nor is the information contained herein meant to constitute legal advice. In addition to the federal laws, each state has its own drug enforcement laws, which may impact on the procurement and use of unapproved drugs. It is recommended that, if you are a participant of the APA-endorsed Psychiatrists' Professional Liability Insurance Program, you should contact the Risk Management Consultation Service provided by Professional Risk Management Services, Inc., (The Program Manager), to assist you in determining whether or not you should seek legal advice before proceeding in this area. The author hopes that this article will provide a starting point for discussion among psychiatrists as to when, and under what protocol, the use of such drugs should be considered.

Introduction

There are a number of psychiatric drugs, including Moclobemide, Mianserin, Sulpiride and Flupenthixol, which are approved for use in other countries but have not been approved by the Food and Drug Administration (FDA) and thus are not legally available in the United States. Psychiatrists have access, through the literature, via international professional meetings, from colleagues, and by other means, to the information available from the results of research studies regarding the use, safety, and efficacy of these drugs. Based on this information, a psychiatrist may wish to consider the use of unapproved drugs¹ for a patient, especially in cases of severe illness where pharmaceutical intervention with approved drugs has been unsuccessful. Many patients likewise have access to information about unapproved drugs through the popular press, patient advocacy groups, the Internet, etc. They may request or even demand that a physician prescribe an unapproved drug. Both the psychiatrist and the patient, when dealing with a situation which may involve the use of unapproved drugs for patient treatment, need to have a clear understanding of the clinical and legal issues that may be faced when this type of treatment is being considered.

Access to unapproved drugs may be available, in limited circumstances, pursuant to regulations promulgated under the authority of the FDA. While individual situations may vary, a psychiatrist who wishes to offer a patient treatment with unapproved drugs needs to have a clear understanding of both the clinical and legal issues that must be addressed. This article will: 1) give an overview of the FDA's responsibility and procedures for the approval of new drugs, including its authority to control the importation of unapproved drugs into the United States; 2) discuss the limitations of, and problems with, the "personal use" exception for access to non-approved drugs; 3) provide information about FDA regulations that authorize the use of unapproved drugs for patients with severe illnesses who could benefit from such use and for whom no satisfactory alternative approved drugs are available; 4) review how the individual psychiatrist may be involved in this process; 5) discuss professional liability insurance coverage related to the prescription and use of non-approved drugs; and 6) suggest how the individual psychiatrist may, through the use of good risk management techniques, minimize potential professional liability while considering all appropriate clinical options for a patient. This article will not address the clinical aspects associated with this subject.

Overview of the FDA'S Responsibility and Procedures

The FDA is one of the federal agencies responsible for ensuring the health and safety of the American public. The FDA carries out its congressional mandate by making as certain as possible that the foods, drugs, cosmetics and medical devices available to the public are effective, safe, and labeled appropriately for their intended use. The authority for the FDA to carry out this responsibility comes from the 1938 Federal Food, Drug, and Cosmetic Act.² The 1938 Act sets out the requirement that all "new drugs" must be tested by manufacturers and evaluated for safety by the FDA before they can be commercially distributed.³ Pursuant to this authority drugs may not be brought into, or marketed within, the United States and its territories unless they have met the requirements of the FDA. Since its enactment in 1938, the Act has undergone numerous amendments. As a result, the FDA's regulatory authority extends to all aspects of the development and approval process for new drugs and medical devices. In particular the 1962 Kefauver-Harris Drug Amendments to the Act tightened FDA controls over the new drug approval process. The 1962 amendments require, among other things, that drug manufacturers prove the effectiveness of the drug for its intended use, as well as the safety of the drug, before it can receive FDA approval.⁴

Among the benefits of the FDA's extensive authority and regulatory control is a high level of safety and reliability for drugs and medical devices approved for use in the United States. However, such a rigorous and extensive approval process is costly and takes many years to complete. Only one out of five thousand new drugs completes the approval process at an average cost to the manufacturer of between $100 million to $400 million.⁵ The FDA estimates that it takes eight and a half years for a new drug to go through the entire approval process before it is available to the general public.⁶ In some cases, drug companies, that have developed drugs which have been approved for use and are available in other countries, may never seek FDA approval because the cost, lack of financial incentives, and the lengthy approval process deter them. This means that some beneficial new drugs will never go through the FDA approval process, and it will take a long time before others are available for patients who could benefit from their use. Consequently, individuals seeking access to unapproved drugs may consider importing drugs into the United States for personal use.

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