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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Appendix D: Survey of Pharmaceutical Companies
Appendix D: Survey of Pharmaceutical Companies
Pages 215-226
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From page 215... ...
Figure D.1 indicates how respondents rated the uncertainty or risk involved in R&D issues in the field of drug addiction as compared with the fields of cancer, AIDS, and cardiovascular disease. Clearly, these results are not a quantitative assessment of the industry, but the drug-addiction field is perceived to be high risk in all areas except for likelihood of competitive advantage over other treatments and likelihood of fast track FDA review.
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From page 216... ...
difficulty in conducting clinical trials 4 other reasons (please state/explain) · Beyond current focus on neurological disorders · Drug discovery (and development)
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From page 217... ...
? R&D tax credits · Guaranteed market exclusivity for ten years or more · Availability of government sponsored patents on an exclusive basis · Guaranteed pricing freedom to achieve high margins to enable re-investment in R&D, educational programs, and broad marketing None, no commercial interest Sponsor preclinical support Reclassification of many schedule I drugs to schedule II Indemnification for usage in subject populations 5.
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From page 218... ...
· Large unmet medical need. · Significant experience in treating nicotine addiction shows that programs can be commercially viable.
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From page 219... ...
Offer consultative support to ongoing industrial research We have concerns about handing over control of the product development decision making to NIDA along with the official involvement of pricing, plus the likelihood of "unofficial" pressures to continue development even if the sponsor wished to discontinue. The involvement of tax dollars in "for-profit" drug development projects by pharmaceutical companies is also viewed as risky in today's political climate.
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From page 220... ...
The responses are displayed in Figure D.1. Sufficient scientific knowledge of disease to begin a drug discovery/drug development program Availability of screening techniques and animal models Clear efficacy endpoints for ethical studies Availability of qualified clinical investigators Likelihood of fast track review or special handling by FDA 6.
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From page 221... ...
Good public image; intangible benefits to company or other company products. High 5 4 In - 3 lo ~ 2 Law High 5 4 3 1 o - ._ _ _ _ _ _1 1 1 - 8111 1 _1 1 LOW _ Liability At ~Competi6 - Reimh~t Invoke ~ht~ O _ C ~_ _1 1 ~_ l ~_ l I~Im ~ ~1 _~1 4@~ Scieno ~Screening Endpo nts Personnel FOA re~new P~entab~ 1 1 1~ 1 ~ _ _ (Ca~ ~ Den Ah - e O AIDS g' Cation i Figure D
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From page 222... ...
· Fund special NIDA extramural research efforts via executive branch edict or legislation. · Need further mechanistic work, availability of modern day screens, etc.
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From page 223... ...
more flexibility in evaluating animal pharmacology should be allowed. · Automatic priority ranking for any drug with significant lower abuse of target agents.
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From page 224... ...
. Insurance pool similar to vaccines for products intended to treat drug liability.
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From page 225... ...
· Tax advantages would have to support the low prices necessitated by this class of drug. · Make drug treatment programs mandatory part of HMO and insurance industry payment programs.
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From page 226... ...
It's a no win situation. Other comments: · Drug efficacy must be assessed in the context of overall care for the addict; clinical studies isolating drug from other modalities may set unrealistically high hurdles.
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