The Development of Medications for the Treatment of Opiate and Cocaine Addictions Issues for the Government and Private Sector (1995) / Chapter Skim
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7 Federal Laws and Regulations
7 Federal Laws and Regulations
Pages 154-172
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From page 154... ...
This chapter also presents recommendations aimed at accelerating drug discovery and development by removing obstacles to the private sector. CREATION OF A DRUG BY THE PHARMACEUTICAL INDUSTRY More than 90 percent of new drugs are discovered by scientists in the pharmaceutical industry (Kaitin et al., 1993; PMA, 1993b)
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From page 155... ...
Drug discovery makes use of basic biomedical knowledge, but its end products are a new chemical entity and information on what it does; much of this information is considered proprietary, and new chemical entities are patentable as inventions. Drug discovery as an organized enterprise takes place almost exclusively in the pharmaceutical industry.
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From page 156... ...
the drug must be withdrawn because of a safety problem. An important characteristic of the marketing period, not widely recognized by the public, is that new uses for a drug are often found after initial marketing as the result of serendipitous discovery by an astute clinician or planned studies by clinical investigators in new patient populations.
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From page 157... ...
For a shared development program MDD in partnership with a private organization in which the government supported clinical development, the cash outlay of public funds would be about half the total cost. Individual pharmaceutical and biotechnology companies have continuing research programs searching for new psychoactive chemicals; some might also have marketed drugs that could be useful in treating one aspect or another of addiction in addition to their primary uses.
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From page 159... ...
Under the treatment-IND regulations, FDA may approve the distribution of an investigational drug outside the context of controlled clinical trials to treat patients with serious or immediately life-threatening diseases for which no comparable or satisfactory alternative therapy is available [21 CFR § 3 12.34a. For this purpose, FDA defines a disease, including a stage in the progression of a disease, to be immediately life-threatening if "there is a reasonable likelihood that death will occur within a matter of months" or "if premature death is likely without early treatment" [21 CFR § 312.34(b)
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~2~. Most of the customary IND procedural requirements apply to treatment INDs, including informed-consent requirements and prohibitions on proapproval promotion or other commercialization of experimental treatments (although companies normally may charge to cover costs)
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From page 161... ...
DHHS, 19921.' With its goals of reaching patients beyond the scope of standard therapy or conventional clinical trials, parallel track provides a prototype for expanding access to treatment to addicted patients, who share some general characteristics with AIDS patients. For example, it is often difficult to find drug-addicted individuals who qualify as subjects for controlled clinical trials.
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From page 162... ...
Market Exclusivity and Orphan Drug Status Other potential sources of incentives for anti-addiction drug development are the various statutory exclusivity provisions. The 1984 Drug Price Competition and Patent Term Restoration Act (DPC-PTR Act, Public Law 98-417)
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From page 163... ...
This law, enacted in 1983 and amended several times, is intended to encourage the development of drugs needed to treat rare diseases whose potential sales might not justify funding of the animal and clinical trials needed to bring products to approval. The standard for orphan status is whether a drug is intended to treat a "rare disease or condition," i.e., a disease or condition that affects fewer than 200,000 persons in the United States or that affects more than 200,000 but for which there is no reasonable expectation of recovering development costs from sales in the United States.
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From page 164... ...
The question of appropriate clinical end points in establishing the effectiveness of anti-addiction drugs has long been debated for a number of reasons, including the nature of the patient population, the use of women and pregnant drug users in clinical trials, the ethics of using placebo or no-treatment controls, and the difficulties of measuring abstinence and recidivism. In principle, the ideal clinical end point would be cessation of drug addiction without the need for maintenance therapy with a treatment drug.
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From page 165... ...
When FDA reviews a new drug product with a potential for abuse, it must notify DEA (Controlled Substances Act § 201(f)
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From page 166... ...
Specifically, a Schedule I drug has a high potential for abuse, has no accepted medical use in treatment in the United States, and there is a lack of accepted safety for use of the drug under medical supervision; a Schedule II drug has a high potential for abuse and has an accepted medical use in treatment in the United States or an accepted medical use with severe restrictions, and its abuse might lead to severe psychologic or physical dependence; a Schedule III drug has a lower potential for abuse than a Schedule I or II drug and has an accepted medical use in treatment in the United States, and its abuse might lead to moderate or low physical dependence or high psychologic dependence; a Schedule IV drug has a lower potential for abuse than a Schedule III drug and has an accepted medical use in treatment in the United States, and its abuse might lead to less physical or psychologic dependence than a Schedule III drug; and a Schedule V drug has a lower potential for abuse than a Schedule IV drug and has an accepted medical use in treatment in the United States, and its abuse might lead to less physical or psychologic abuse than a Schedule IV drug [CSA § 202(b)
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From page 167... ...
As stated above, pioneer drug manufacturers might be eligible for patent-term extension to allow them to recoup the time lost during regulatory review. In calculating the review period for controlled substances, however, FDA does not count the time lost after approval of an NDA through scheduling by DEA (FDA, 1988~; this time is unrecoverable by the manufacturer.
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From page 168... ...
Although holders of INDs for controlled substances are exempt from some DEA requirements that parallel FDA requirements, DEA still maintains substantial authority over the manufacture, distribution, and research use of controlled substances, subjecting researchers of new anti-addiction drugs to a dual regulatory scheme.
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From page 169... ...
~. In addition, FDA regulations mandate that investigators and sponsors in clinical trials using controlled substances take special precautions, including storage of the drug in a secure place with limited access, to prevent theft or inappropriate diversion [21 CFR §§ 312.69, 312.58(b)
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The committee recommends that action be taken to remove the adverse effects of DEA requirements, under the Controlled Substances Act (CSA) , on clinical research investigations involving controlled substances, by holders of active FDA INDs, either by amending the CSA to exempt such investigations from applicable DEA regulations or by the alternative administrative and regulatory measures: .
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From page 171... ...
CONCLUSIONS Lee committee concludes that the complexities faced in the normal process of drug discovery and development are made even more daunting arid costly by the multitude of regulations arid clinical research constraints imposed by FDA and DEA in the development of anti-addiction medications. Thus, the committee has offered recommendations with the intent of easing the regulatory disincentives to the pharmaceutical industry and expediting the availability of new phannacotherapies for heroin and cocaine addicts.
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From page 172... ...
Rapaka RS, Hawks RL, eds.1993. Medications Development: Drug Discovery, Databases, and Computer-Aided Drug Design.
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