Content by Keyword: Drugs, Medical Devices, and Pharmacy Services

The prospect of splitting a small market with competitors may render a project financially infeasible. Provisions for market exclusivity via the existing Orphan Drug Act and the 1984 Drug Price and Competition and Patent Term Restoration Act, and/or similar means are necessary but not sufficient for lowering the barrier of a small and uncertain ma

Through purchase orders or other means, government and/or other major payers could guarantee a substantial minimum market for a cocaine addiction pharmacotherapy. Guaranteeing a market in terms of number of patients and/or a number of drug units, a given price, and a specified period of time, would address directly the barrier of limited and uncer

Improving the substance abuse treatment system can address a critical barrier to market access. Greater funding of treatment centers could increase the number of patients treated. It could also increase available spending per patient, enabling greater market penetration and more substantial prices for effective drugs. Requiring all substance abuse

In general, the investment to produce a new drug for a small market is no different than producing a new drug for a large market, but a company is less likely to recoup its investment in a small market. Government funding of new drug development can raise the science base and move any promising drug closer to launch. Improving the science base can

Any public policies intended to improve opportunities for developing pharmacotherapies for cocaine addiction must address the three critical barriers described here. It is not within the scope of this study to identify or analyze specific public policies to promote development or marketing of pharmacotherapies for substance abuse.

There was a divergence of opinion among the pharmaceutical company interviewees about the readiness of the science base for cocaine pharmacotherapies. Representatives of two companies expressed skepticism about the readiness of the science base. One representative indicated that current limitations stem from a lack of understanding regarding the b

Industry decision makers recognize the heavy reliance of the substance abuse market on federal, state, and local government reimbursement. The perception among the drug companies is that many cocaine addicts do not have private insurance and rely on federal and state government sources for treatment, and that only a portion of those individuals wi

There are multiple, interrelated aspects of the current substance abuse treatment system that limit the market prospects for any new pharmacotherapy for cocaine addiction. These limitations are apparent in the case studies, were raised by company executives interviewed for this study, and are corroborated by modeling of certain scenarios. Sales of

The small size and uncertainty of the market for cocaine pharmacotherapies constitutes a critical barrier to development of a cocaine abuse pharmacotherapy. Although all of the company executives interviewed for this study agreed that the total number of cocaine users is appreciable, they recognized that the feasible market for a cocaine abuse tre

Many of the market barriers identified in the 1995 IOM report were confirmed through the sources used for this study. Although no new general types of new market barriers were identified in this study, certain ones were elaborated or described in a more contemporary context.

Under current conditions, pursuing development of a new cocaine pharmacotherapy via a typical full product development cycle is not economically viable from the standpoint of industry. Although a variety of hurdles or procedural impediments may affect prospects for new pharmacotherapy development in this area, most of these are regarded as surmoun

There was a divergence of opinion among the pharmaceutical company interviewees about the readiness of the science base for cocaine pharmacotherapies. Representatives of two companies expressed skepticism about the readiness of the science base. One representative indicated that current limitations stem from a lack of understanding regarding the b

Social stigma of drug abusers was cited as a market barrier by representatives of two of the pharmaceutical companies, though it is regarded as surmountable if the commercial and scientific viability of the product is favorable. The pharmaceutical companies that identified social stigma as a barrier were familiar and sympathetic to the case experi

Two market barriers related to drug marketing were identified. As previously described, the possibility of the pharmacotherapy being distributed through publicly-funded treatment centers rather than through physician offices was a concern of the pharmaceutical companies because of the companies' limited access to patients.

The clozapine case study demonstrates that special requirements for approved use and other atypical restrictions can pose significant market barriers. Clozapine has a potentially fatal side-effect, agranulocytosis, that warrants strict patient monitoring. This contributed to clozapine's being approved as a second- or third-line therapy, i.e., for

DEA regulation was not generally cited by pharmaceutical company representatives as a market barrier. One interviewee mentioned the potential risk of exposing an existing successful product used for other indications to cocaine treatment. The company indicated that the increase in development costs of the drug and the potential for rescheduling of

The uncertainty associated with designation of required clinical endpoints to be used in clinical trials of medications for cocaine addiction was cited as a market barrier, though not a major one. Two pharmaceutical company interviewees identified this ambiguity as a potential barrier, and one company representative expressed some concern that "ch

Three of the four case study drugs were for patient populations perceived to be difficult to study for a variety of reasons (e.g., patient recruitment, compliance, and co-morbidities). For example, patient compliance has been seen as a barrier to the success of naltrexone in both the heroin addiction and alcoholism markets, because the drug is not

Several points within the drug approval process were seen by industry as potential market barriers to product development in this field. However, as a group, none were viewed as major barriers that could not be surmounted, especially if the market barriers cited as critical ones above were lowered or eliminated.