Using national survey data and risk equations from the Framingham Heart Study, we quantify the impact of antihypertensive therapy changes on blood pressures and the number and cost of heart attacks, strokes, and deaths. Antihypertensive therapy has had a major impact on health. Without it, 1999-2000 average blood pressures (at age 40+) would have been 10-13 percent higher, and 86,000 excess premature deaths from cardiovascular disease would have occurred in 2001. Treatment has generated a benefit-to-cost ratio of at least 6:1, but much more can be achieved. More effective use of antihypertensive medication would have an impact on mortality akin to eliminating all deaths from medical errors or accidents. [Health Affairs 26, no. 1 (2007): 97-110; 10.1377/hlthaff.26.1.97] M an y ana lys ts ag r e e t h at m e d i c a l i n n ovat i o n, whether in the form of new drugs, medical devices, diagnostic techniques, or procedures, has resulted in substantial improvements in both quality and length of life. However, estimating the actual societal value of medical innovation remains a challenge. The medical literature reports results from scores of randomized clinical trials measuring the relative safety and efficacy of specific treatments on individuals in highly controlled settings, but there are few careful estimates of the societal impact of specific medical innovations with real-world average rates of diagnosis, compliance, and clinical impact.Real-world experience may differ from that in highly controlled clinical trials. Patient compliance rates may be lower. Further, the overall population may be

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Objective: To provide evidence on recent trends in: (1) market exclusivity periods (MEPs, the time between launch of a brand-name drug and its first generic competitor) for new molecular entities (NMEs); (2) the likelihood and timing of patent challenges under Paragraph IV of the Hatch-Waxman Act; and (3) generic drug penetration.

With spending on biologics rising and patent expiry approaching for several blockbuster biologics, Congress and the Food and Drug Administration are considering creating a clear pathway for so-called follow-on biologics. Differences between drugs and biologics will affect market outcomes in various ways. Conservative budget impacts are appropriate in the short run because fewer competitors will enter, and average prices will drop less than was the case following the Hatch-Waxman Act. Over the long term, intellectual property provisions will be important considerations for policymakers designing a pathway for follow-on biologics that balances price competition and innovation incentives. [Health Affairs 25, no. 5 (2006):

Objective: To provide updated evidence on US trends in: market exclusivity periods (MEPs, time between brand-name drug launch and first generic competitors) for new molecular entities (NMEs); likelihood, timing and number of Hatch-Waxman Act Paragraph IV patent challenges; and generic drug penetration.