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The Effect of FDA Advisories on Branded Pharmaceutical Firms' Valuations and Promotion Efforts

Conti, Rena M.; Huskamp, Haiden A.; Berndt, Ernst R. - National Bureau of Economic Research (NBER) - 2011

The US Food and Drug Administration (FDA) expends considerable efforts in regulating medications approved for use. Yet the impact of medication labeling changes on brand pharmaceutical products, and whether and what firms do to respond to increased information regarding the safety and efficacy...

Persistent link: https://www.econbiz.de/10009325511

Brand Loyalty, Generic Entry and Price Competition in Pharmaceuticals in the Quarter Century After the 1984 Waxman-Hatch Legislation

Berndt, Ernst R.; Aitken, Murray L. - National Bureau of Economic Research (NBER) - 2010

following initial generic entry and by 24 months to 65, in 2009 the comparable generic price indexes are 68 and 27, respectively … patent has expired. Across all nine therapeutic areas, at 24 months post-generic entry, the weighted mean reduction in …

Persistent link: https://www.econbiz.de/10008682661

Specialty drug prices and utilization after loss of U.S. patent exclusivity, 2001-2007

Conti, Rena M.; Berndt, Ernst R. - National Bureau of Economic Research (NBER) - 2014

estimated prices of these drug undergoing LOE fall with generic entry. Second, we estimate reduced form random effects models of … utilization subsequent to LOE. We observe substantial price erosion after generic entry; average monthly price declines appear to … entry, but this result appears to be largely driven by oral drugs. We discuss second-best welfare consequences of these …

Persistent link: https://www.econbiz.de/10010950850

Pricing and Reimbursement in U.S. Pharmaceutical Markets

Berndt, Ernst R.; Newhouse, Joseph P. - National Bureau of Economic Research (NBER) - 2010

comment on very recent developments concerning the entry of large retailers such as Wal-Mart into domains traditionally …

Persistent link: https://www.econbiz.de/10008531891

Costs, Institutional Mobility Barriers, and Market Structure: Advertising Agencies as Multiproduct Firms

Silk, Alvin J.; Berndt, Ernst R. - National Bureau of Economic Research (NBER) - 1994

low fixed costs and minimal entry barriers, both media-specific scale and scope economies are available and can be …

Persistent link: https://www.econbiz.de/10005248932

Characterizing Markets for Biopharmaceutical Innovations: Do Biologics Differ from Small Molecules?

Trusheim, Mark; Aitken, Murray L.; Berndt, Ernst R. - National Bureau of Economic Research (NBER) - 2010

Much has been written about the seemingly less formal, more agile biotechnology industry and its extensive interactions with academia and startups, as well as its distinct scientific, manufacturing and regulatory profile. Employing a data base encompassing all 96 biologics and 212 small...

Persistent link: https://www.econbiz.de/10008635919

Advanced Purchase Commitments for a Malaria Vaccine: Estimating Costs and Effectiveness

Kremer, Michael; Berndt, Ernst R.; Glennerster, Rachel; … - National Bureau of Economic Research (NBER) - 2005

To overcome the problem of insufficient research and development (R&D) on vaccines for diseases concentrated in low-income countries, sponsors could commit to purchase viable vaccines if and when they are developed. One or more sponsors would commit to a minimum price that would be paid per...

Persistent link: https://www.econbiz.de/10005778504

Assessing the Impacts of the Prescription Drug User Fee Acts (PDUFA) on the FDA Approval Process

Philipson, Tomas; Berndt, Ernst R.; Gottschalk, Adrian H. B. - National Bureau of Economic Research (NBER) - 2004

Congress enacted and renewed the Prescription Drug User Fee Acts (PDUFA) in 1992, and renewed it in 1997 and 2002, mandating FDA performance goals in reviewing and acting on drug applications within specified time periods. In turn, the FDA was permitted to levy user fees on drug sponsors...

Persistent link: https://www.econbiz.de/10005084928