Cease-and-Desist letter from U.S. DEA to Celltech Pharmaceuticals, purveyor of the controlled substance methylphenidate.
Cease-and-Desist letter from the U.S. DEA.
U.S. Department of Justice   ~   Drug Enforcement Administration   ~   Washington, D.C. 20537   ~   Aug 21 2001
Mr. Ian Garland   ~   Chief Operating Officer   ~   Celltech Pharmaceuticals, Inc.   ~   755 Jefferson Road   ~   Rochester, New York 14623
Dear Mr. Garland:
The Drug Enforcement Agency (DEA) has learned of Celltech Pharmaceuticals advertising Metadate® (methylphenidate HCl), a Schedule II controlled substance, directly to the public via magazines. DEA is quite concerned about the issue of direct-to-consumer controlled substance advertising and we would like to meet with you about this important issue.

In enacting the Controlled Substances Act (CSA), Congress sought to minimize the quantity of drugs of abuse available to those who are prone to use them. To accomplish this, Congress established a closed regulatory system for persons who legitimately manufacture, distribute, dispense or possess controlled substances. Through various mechanisms, including the use of Schedule I and II production quotas, the CSA was designed to limit the availability of these lawfully manufactured controlled substances to the quantities necessary to meet the legitimate medical and scientific needs of this country. (Drug products in Schedules III and IV, although not subject to production quotas, also contain some of the most widely prescribed and abused substances.) Advertising controlled substances directly to the American public is incongruous with congressional intent to protect the public health and safety from a variety of predictable risks and, as such, poses a significant risk to the national problem of controlled substance diversion. Advertising Metadate® directly to consumers might well be contrary to the public interest.

DEA and the pharmaceutical industry have had a thirty year understanding that [controlled substance] direct-to-consumer advertising is contrary to the spirit of the CSA and is contrary to the public health and safety. DEA reiterated this position most recently to members of the industry attending our Pharmaceutical Conference in Seattle, Washington, in September 2000. We have been pleased that the pharmaceutical industry voluntarily refrained from engaging in this sort of advertising and promotion until recently.

The United Nations recently queried DEA regarding its concern about direct-to-consumer advertising of psychotropic substances which, as you know, is prohibited under Article 10 of the 1971 Psychotropic Convention. Methylphenidate is a psychotropic substance that is controlled in the U.S. and under that treaty. The intent of the advertising prohibition in the treaty is the same as that of Congress, i.e., to limit the availability of controlled substances to legitimate medical and scientific needs. DEA's the competent authority in the U.S. for implementing and monitoring compliance requirements of the Psychotropic Convention. As such, DEA is compelled to bring this potential treaty violation to your attention.

Controlled substances are drugs of abuse and the subject of drug-seeking behavior. Thus, the demand for these substances exceeds the legitimate need for them. While there may be several purposes for advertising a product, one major purpose is to create or stimulate demand. In past years, advertising certain controlled substances did increase the demand for them. A proliferation of advertisements targeting physicians, for example, focused on treating the complaints of housewives, traveling salesman and college students with amphetamines and tranquilizers. Physicians were encouraged to use psychoactive drugs as the treatment of choice for everyday life problems. These advertisements, appearing health and medical journals, were aimed at physicians and other healthcare professionals, and abuse became more widespread. Drug abusers, particularly narcotic addicts, try to obtain controlled substances by persuading physicians to prescribe or dispense controlled substances to alleviate phony symptoms. Advertising prescription drugs, particularly controlled substances, directly to consumers potentially contributes to this problem.

DEA is also concerned about directly advertising controlled substances to the public because of the inability of patients to understand medical information and make a rational, informed choice of medication from an array of drugs making similar claims. We are also concerned about over-medication and about the messages conveyed to our youth.

Physicians and other healthcare professionals are the appropriate targets of controlled substance advertising. They have the training and expertise to interpret the information in the advertisements and apply that information appropriately to the medical needs of each individual patient. This is especially important for powerful drugs with potential for abuse and dependence. It is questionable whether the average lay person could sift through product information contained in advertisements and form an educated opinion about the risks versus the benefits of particular products. Consumers generally lack the medical background or education required to do this. Physicians have the training as well as the ethical responsibility to demand and weigh balanced information about drug products. The decision to prescribe any drug must involve a consideration of the therapeutic benefits of the medication with its side effects, as part of the overall physician-patient interaction.

The pharmaceutical industry currently directs a number of promotional activities only at physicians and healthcare professionals. Such activities include drug sampling, professional journal and direct mail advertising, films, pamphlets, seminars and convention displays. Interaction between the physician and patient enables the physician to determine the appropriate medication based upon the agent's pharmacology, time and frequency of administration, form and size of the dosage and the physiological and psychological make-up of the patient. Direct-to-consumer advertising could lead to increased pressure on physicians to prescribe drugs that are unnecessary or inappropriate for the patient and to an erosion of the physician-patient relationship.

A practicing physician has assumed the responsibility to alleviate pain and prolong life, and is governed by a code of ethics that obliges putting the health and welfare of the patient foremost. Prescribers are licensed by the states in which they practice, and they must adhere to strict regulatory standards imposed by appropriate state governing boards. They may be held liable if they violate such standards. Regulatory liability does not extend on an individual consumer-patient basis to the commercial aspects of pharmaceutical manufacturers and distributors, which could lead to abuses by unscrupulous manufacturers and distributors.

DEA recognizes that pharmaceutical companies need ways to inform the public about their products. Advertising that promotes the company's name, its research efforts, length of time in business, competitive prices, history of quality and innovative service, etc. is a viable way to proceed without promoting a specific controlled product. Overall product demand is not affected in this way, while the best interests of the company and the consumer-patient are served. Educating the consumer about controlled substances is indeed worthwhile, but direct advertising is not the appropriate method. Consumer education is best achieved through public information campaigns, booklets and other means that address health topics but do not promote specific products.

It is for these reasons that DEA opposes all Metadate® advertising directly to consumers. I look forward to your response and to achieving a mutually satisfying agreement in resolving this matter.
Laura M. Nagel   ~   Deputy Assistant Administrator   ~   Office of Diversion Control
cc: DPM [BLACKED OUT] (New York)
ODLR [BLACKED OUT] __________8/10/01
Document Name: advertcelltech.doc
FFS: 601-04-A2
Subject: Methylphenidate Direct-to-Consumer Advertising
OD Circ
ODL Circ
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