The Development of Medications for the Treatment of Opiate and Cocaine Addictions Issues for the Government and Private Sector (1995) / Chapter Skim
Currently Skimming:
9 Market Obstacles and Creating Incentives
9 Market Obstacles and Creating Incentives
Pages 187-200
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 187... ...
That this lack of success persists, despite the dire health, social, and economic consequences of drug addiction, further attests to the many barriers faced by the pharmaceutical industry. The committee believes, however, that many of the barriers can be overcome with changes in government policies and a full commitment of resources to this area of medications development.
|
From page 188... ...
However, a variety of reasons, including limited scientific understanding of the physiological bases of addiction, craving, and relapse, numerous marketing obstacles, and the failure to identify pharmacotherapeutic research and pharmacotherapies as national priorities, have prevented NIDA from forming effective partnerships. The committee notes that any progress in attracting the private sector to the difficult task of developing new anti-addiction medications will require strong and sustained federal leadership and research support.
|
From page 189... ...
MARKET OBSTACLES AND CREA TING INCENTI VES Bias by sorry Learnt providers against pharmacologic treabrmnts Limited number of narcotic treatment programs Small Reign market _ Lack of traditional marketing to physicians Varied stat~ocal approval processes Length of FDA ~ approval process Patient population perceived as difficult to study Complications of concomitant illness and polydrug use Lack of well-characterized animal models of cocaine addiction | Uncertain market L I environment I Uncertaintreabnent financing ~Treatment ~ ~ Varied state/local treatment regulations \`System J and financing mechanisms ~ ~ Stigma of drug-abuse Marketing Other Approval File NDA Clinical Studies File IND Discovery ~ Pricing clause in DHHS CRADAs Varied state and local regulations DEA review time ' State rescheduling ' Few clinical investigators ' DEA regulations _ Efficacy outcomes difficult to define or measure Limited basic science knowledge of addiction, craving, and relapse Limited number of researchers focusing on drug abuse _ (recision toinvestin Be| Lack offederalleadership | | R&D of new anti- J addiction medications ED FIGURE 9.1 Current problems in the development of anti-addiction medications.
|
From page 190... ...
, met with the Institute of Medicine (IOM) Forum on Drug Development, and held a Workshop on Policies to Stimulate Private Sector Development of AntiAddiction Medications (Appendix F)
|
From page 191... ...
To address the issue of return on investment, the committee has endorsed a host of recommendations throughout the report for the federal government to consider and offers additional recommendations in this chapter to offset the major obstacles. The Orphan Drug Act (Public Law 97-414)
|
From page 192... ...
Alternatively, new legislation similar to the Orphan Drug Act could be drafted specifically for FDA-approved anti-addiction medications. This is a more explicit recommendation than the one previously stated in the committee's preliminary report issued March 1994.2 The committee believes that the designation of orphan or orphanlike status for approved anti-addiction medications is necessary to stimulate market investment as financial return is limited, given the nature of the anti-addiction market.
|
From page 193... ...
3 Section 8.3 of the NIH Patent Policy Board's Model CRADA states that the institutes' concern is that "there be a reasonable relationship between the pricing of a licensed product, the public investment in that product, and the health and safety needs of the public. Accordingly, exclusive commercialization licenses granted for NIH intellectual property rights may require that this relationship be supported by reasonable evidence." 4This recommendation is revised from the committee's preliminary report published In March 1994.
|
From page 194... ...
NIH could assign additional staff members or establish a centralized committee to eliminate the need for multiple levels of review and provide a single site for negotiating and approving CRADAs (IOM Workshop, June 13, 1994~. Societal Stigma The societal stigma of developing and marketing a medication for treating drug-dependent patients is a concern for pharmaceutical companies.
|
From page 195... ...
MDD organized successful multicenter clinical trials that included expedited FDA drug approval. In this accomplishment, MDD not only completed the development of LAAM but organized a network of clinics and investigators that could participate in future Phase III studies of other drugs.
|
From page 196... ...
Yet the number of federal agencies involved, current agency funding and staffing levels, regulatory requirements, remaining scientific questions, and other issues present difficult challenges to successful partnership and cooperation. Although many of the challenges are addressed in this report, it is important to recognize that government policies have not provided a strong emphasis on pharmacotherapy for the treatment of drug addiction.
|
From page 197... ...
Although it is possible to envision incentives that would interest some pharmaceutical companies (e.g., small pharmaceutical companies, biotechnology companies, or those companies already involved in the development of CNS compounds) without strong federal leadership, in establishing the role of pharmacotherapy and a long-term federal commitment to research, the committee believes all other efforts are likely to falter.
|
From page 198... ...
requirements under the Controlled Substances Act; and counting DEA review time as part of the regulatory process for purposes of patent term extension for controlled substances. The creation of modest incentives should include broad interpretation of the Orphan Drug Act to include anti-addiction medications or similar legislation to stimulate the market in the development of anti-addiction medications; a strong federal leadership role in support of treatment of drug-dependent patients; funding of basic research and training; adequate funding of treatment; and a modification or elimination of the "reasonable pricing clause" in CRADAs.
|
From page 199... ...
The options presented above were favored by a majority of the committee. Most committee members also favored implementation of those extraordinary incentives only if the first two tiers of recommendations fail to stimulate progress in the ar~ti-addiction medications market.
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.