Browsing by Author "Grabowski, Henry G"
Now showing 1 - 20 of 31
Results Per Page
Sort Options
Item Open Access A New Look at the Returns and Risks to Pharmaceutical R & D(Management Science, 1990-07) Grabowski, Henry G; Vernon, JohnItem Open Access Are the Economics of Pharmaceutical R&D Changing? Productivity, Patents and Political Pressures(PharmacoEconomics, 2004) Grabowski, Henry GPharmaceutical R&D competition in the 1980s and 1990s was characterized by rising R&D expenditures, favorable returns to innovators, and the introduction of many new classes of drugs with high social benefits. However in the past three years the number of new drug introductions has been below the historical trend, while costs per new drug continue to increase. Another important concern affecting the industry is the fact that many leading drugs under patent are being challenged by generic firms. Under the 1984 Hatch-Waxman Act, generic firms have strong incentives to be the first to challenge a patent given the 180 day exclusivity provision. Many generic firms have developed a business model which involves prospecting in patent suit challenges. Congress is currently considering legislative changes to the 1984 Act, but is not addressing this important issue. Looking forward, a key issue will be how the pending Medicare Rx drug benefit is implemented. Initially Congress is likely to structure the Medicare benefit using traditional PBM and managed care competition to keep costs in check. However, Medicaid programs recently have become more aggressive in their cost containment programs. Many states have adopted preferred drug lists with prior authorization and thirteen states now have quantity limits on the number of prescriptions per month. Over time Medicare will likely confront similar budgetary problem to the states’ and experience pressures to expand the scope of the program. A long term dynamic toward more aggressive cost containment would have particularly adverse consequences for innovation.Item Open Access Brand Loyalty, Entry, and Price Competition in Pharmaceuticals after the 1984 Drug Act(1992-10) Grabowski, Henry G; Vernon, John MIN 1984, Congress enacted a new law that greatly affected the economics of the pharmaceutical industry in the United States. It has been characterized as the most important legislation affecting competition in the pharmaceutical industry since the 1962 Kefauver-Harris Amendments to the Food and Drug Act. This 1984 law, known as the Drug Price Competition and Patent Term Restoration Act (hereinafter the 1984 Act), facilitated the entry of generic drug products after patent expiration while it also restored part of the patent life lost during the premarket regulatory process for new introductions.1 Market entry by generics was relatively limited prior to 1984 because of costly Food and Drug Administration (FDA) requirements that had to be met by the imitative products. That is, generic drugs often would have to duplicate many of the pioneer's tests to gain market approval after patent expiration. As a result of the 1984 law, generic products need only demonstrate bioequivalence to the pioneer's brand, and generic entry has increased significantly. This has provided a body of very interesting data to analyze the pattern of entry and the pricing strategies followed by the entrants and incumbents. In this article, we make use of data covering the sales and prices of the pioneer and generic products for eighteen drug products, generally over the time period 1984-88.Item Open Access Demand Shifting, Optimal Firm Growth, and Rule-of-Thumb Decision Making(Quarterly Journal of Econoics, 1970-05) Grabowski, Henry GItem Open Access Economics of new oncology drug development.(J Clin Oncol, 2007-01-10) DiMasi, Joseph A; Grabowski, Henry GPURPOSE: Review existing studies and provide new results on the development, regulatory, and market aspects of new oncology drug development. METHODS: We utilized data from the US Food and Drug Administration (FDA), company surveys, and publicly available commercial business intelligence databases on new oncology drugs approved in the United States and on investigational oncology drugs to estimate average development and regulatory approval times, clinical approval success rates, first-in-class status, and global market diffusion. RESULTS: We found that approved new oncology drugs to have a disproportionately high share of FDA priority review ratings, of orphan drug designations at approval, and of drugs that were granted inclusion in at least one of the FDA's expedited access programs. US regulatory approval times were shorter, on average, for oncology drugs (0.5 years), but US clinical development times were longer on average (1.5 years). Clinical approval success rates were similar for oncology and other drugs, but proportionately more of the oncology failures reached expensive late-stage clinical testing before being abandoned. In relation to other drugs, new oncology drug approvals were more often first-in-class and diffused more widely across important international markets. CONCLUSION: The market success of oncology drugs has induced a substantial amount of investment in oncology drug development in the last decade or so. However, given the great need for further progress, the extent to which efforts to develop new oncology drugs will grow depends on future public-sector investment in basic research, developments in translational medicine, and regulatory reforms that advance drug-development science.Item Open Access Encouraging the Development of New Vaccines(Health Affairs, 2005) Grabowski, Henry GItem Open Access Estimating the effects of regulation on innovation: an international comparative analysis of the pharmaceutical industry.(J Law Econ, 1978) Grabowski, Henry G; Thomas, Lacy Glenn; Vernon, John MItem Open Access Evolving brand-name and generic drug competition may warrant a revision of the Hatch-Waxman Act.(Health Aff (Millwood), 2011-11) Grabowski, Henry G; Kyle, Margaret; Mortimer, Richard; Long, Genia; Kirson, NoamThe evolution of pharmaceutical competition since Congress passed the Hatch-Waxman Act in 1984 raises questions about whether the act's intended balance of incentives for cost savings and continued innovation has been achieved. Generic drug usage and challenges to brand-name drugs' patents have increased markedly, resulting in greatly increased cost savings but also potentially reduced incentives for innovators. Congress should review whether Hatch-Waxman is achieving its intended purpose of balancing incentives for generics and innovation. It also should consider whether the law should be amended so that some of its provisions are brought more in line with recently enacted legislation governing approval of so-called biosimilars, or the corollary for biologics of generic competition for small-molecule drugs.Item Open Access Extraordinary Claims Require Extraordinary Evidence(Journal of Health Economics, 2005) DiMasi, Joseph A; Hansen, Ronald W; Grabowski, Henry GItem Open Access Follow-on biologics: data exclusivity and the balance between innovation and competition(Nature Reviews Drug Discovery, 2008-06) Grabowski, Henry GItem Open Access Health Reform and Pharmaceutical Innovation(Seton Hall Law Review, 1994) Grabowski, Henry GItem Open Access Innovation in the pharmaceutical industry: New estimates of R&D costs.(J Health Econ, 2016-05) DiMasi, Joseph A; Grabowski, Henry G; Hansen, Ronald WThe research and development costs of 106 randomly selected new drugs were obtained from a survey of 10 pharmaceutical firms. These data were used to estimate the average pre-tax cost of new drug and biologics development. The costs of compounds abandoned during testing were linked to the costs of compounds that obtained marketing approval. The estimated average out-of-pocket cost per approved new compound is $1395 million (2013 dollars). Capitalizing out-of-pocket costs to the point of marketing approval at a real discount rate of 10.5% yields a total pre-approval cost estimate of $2558 million (2013 dollars). When compared to the results of the previous study in this series, total capitalized costs were shown to have increased at an annual rate of 8.5% above general price inflation. Adding an estimate of post-approval R&D costs increases the cost estimate to $2870 million (2013 dollars).Item Open Access Longer Patents for Increased Genetic Competition: The Waxman-Hatch Act After One Decade(PharmacoEconomics, 1996) Grabowski, Henry GItem Open Access Medicaid Patients' Access to New Drugs(Health Affairs, 1988-12) Grabowski, Henry GItem Open Access Patents and New Product Development in the Pharmaceutical and Biotechnology Industry(The Georgetown Public Policy Review, 2003-03) Grabowski, Henry GItem Open Access Patents, Innovation and Access to New Pharmaceuticals(Journal of International Economic Law, 2002-02) Grabowski, Henry GItem Open Access PIONEERS, IMITATORS, AND GENERICS - A SIMULATION-MODEL OF SCHUMPETERIAN COMPETITION(QUARTERLY JOURNAL OF ECONOMICS, 1987-08) Grabowski, Henry G; Vernon, John MItem Open Access Regulatory and cost barriers are likely to limit biosimilar development and expected savings in the near future.(Health Aff (Millwood), 2014-06) Grabowski, Henry G; Guha, Rahul; Salgado, MariaIn March 2010 Congress established an abbreviated Food and Drug Administration approval pathway for biosimilars-drugs that are very similar but not identical to a reference biological product and cost less. Because bringing biosimilars to the market currently requires large investments of money, fewer biosimilars are expected to enter the biologics market than has been the case with generic drugs entering the small-molecule drug market. Additionally, given the high regulatory hurdles to obtaining interchangeability-which would allow pharmacists to substitute a biosimilar for its reference product, subject to evolving state substitution laws-most biosimilars will likely compete as therapeutic alternatives instead of as therapeutic equivalents. In other words, biosimilars will need to compete with their reference product on the basis of quality; price; and manufacturer's reputation with physicians, insurers, and patient groups. Biosimilars also will face dynamic competition from new biologics in the same therapeutic class-including "biobetters," which offer incremental improvements on reference products, such as extended duration of action. The prospects for significant cost savings from the use of biosimilars appear to be limited for the next several years, but their use should increase over time because of both demand- and supply-side factors.Item Open Access Setting the Record Straight on Setting the Record Straight: Response to Light and Warburton's Rejoiner(Journal of Health Economics, 2005) DiMasi, Joseph A; Hansen, Ronald W; Grabowski, Henry GItem Open Access SUBSTITUTION LAWS AND INNOVATION IN THE PHARMACEUTICAL-INDUSTRY(LAW AND CONTEMPORARY PROBLEMS, 1979) Grabowski, Henry G; Vernon, John M