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The Drug Addiction Treatment Act of 1999
ADDITIONAL VIEWS This bill is borne of a concern that potential new opiate addiction treatment medications will be regulated in a manner that will limit their availability and use. The current paradigm for regulation of opiate addiction medications is based on methadone and ORLAAM (a methadone alternative) and includes rigorous federal regulations as well as a variety of state and local restrictions. The only known medications that would be affected by the bill are buprenorphine and a combination product, buprenorphine/naloxone. These products have been developed under a Cooperative Research and Development Agreement (CRADA) between the National Institute on Drug Abuse (NIDA) and Reckitt & Colman. According to NIDA’s Buprenorphine Update, "[t]here are no current regulations which address the use of buprenorphine or buprenorphine/naloxone for the treatment of opiate dependence because these products are not yet approved for this purpose by the FDA." NIDA goes on to state that "[t]he regulatory burden should be determined based on a review of the risks to individuals and society of this medication being dispensed by prescription and commensurate with its safety profile, as is the case with evaluation of all controlled substances." The Federal agency responsible for establishing guidelines for opiate addiction treatment is the Substance Abuse and Mental Health Services Administration (SAMHSA). At a hearing on this legislation and in other communications on this subject, SAMHSA has said that it is in the process of drafting a proposed regulation for buprenorphine. The agency has not argued that the rigorous regulatory paradigm for methadone would be appropriate for buprenorphine. Indeed, SAMHSA has already published a proposal to revise the methadone regulations. The bill exempts "qualifying physicians" at a time when buprenorphine has not been approved by FDA, and therefore before labeling information important to its use is known. According to NIDA, "[t]he safety and effectiveness profiles for buprenorphine and buprenorphine/naloxone suggest they could be dispensed under controlled circumstances that would be delineated in the product labeling and associated rules and regulations." It may be premature to exempt anyone from yet to be written regulations for a yet to be approved and labeled drug. The bill preempts state and local laws that are "in conflict with" it. The National Association of State Alcohol and Drug Abuse Directors (NASADAD) has stated its opposition to the bill’s preemption language. We still do not have an accounting of what state and local laws will be affected by the preemption language of this bill. Finally, the bill does not provide any resources for patient access to buprenorphine. Although the rigor of current narcotic addiction treatment regulations may be a barrier to treatment, evidence presented at the hearing on this bill clearly showed that financial resources are a critical element of access to treatment and to development of effective addiction treatment medications. It is important to note that most persons in the treatment gap lack access to financial resources for treatment. Insurance coverage often does not provide "parity" for substance abuse treatment, and the Medicaid programs of twenty-five states do not pay for methadone treatment. The cost of methadone is less than one dollar per day. Some estimates for the daily cost of buprenorphine are as high as ten dollars per day. Thus, most heroin addicts in the treatment gap will not be able to afford the office based treatment contemplated by the bill. Buprenorphine is expected to be effective for the treatment of mild to moderate heroin addiction. A majority of heroin addicts are severely addicted. Thus, many persons who are in the treatment gap will not benefit from the bill for pharmacological reasons. Their lack of access to treatment is not addressed by the bill. In sum, the bill may ultimately help some heroin addicts to receive treatment, but this number will be a fraction of those who are in the treatment gap. These will be mild to moderately addicted persons with the financial resources to obtain access to a physician or other health care provider who will either dispense or prescribe the medication. The bill does not address the needs of most heroin addicts; namely, those who are severely addicted or who lack the financial resources to see a doctor. Some members have strongly urged the majority to address these aspects of the treatment gap that are not included in H.R. 2634. A good first step would be to move legislation to reauthorize the programs administered by the Substance Abuse and Mental Health Services Administration, which provide the bulk of federal resources for substance abuse prevention and treatment. JOHN D. DINGELL | |
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