February 21, 2015
Representative Fred Upton, chairman of the House Energy & Commerce Committee, recently released a discussion draft of legislative language for the 21st Century Cures Initiative. This initiative attempts nothing less than to “boil the ocean” of regulations and incentives that govern medical innovation in the U.S. The 400-plus-page draft rolls up a number of previously proposed bills (including an updated version of Representative Marsha Blackburn’s SOFTWARE Act, discussed in a previous column).
A large share of the draft incorporates legislation that is designed to improve the incentives for inventing new medicines, or finding new uses for old medicines. This is important, because we are facing a crisis in pharmaceutical innovation.
via 21st Century Cures: Waking Up Dormant Drug Therapies.
February 18, 2015
Stiglitz argues that enshrining stronger protections will slow cheaper generic drugs from entering the market. Not only is this not true, but he also fundamentally misunderstands IP: firms in IP-based industries depend on intangible capital, such as source code, molecular compounds and digital copy-written content. But if competitors are able to enter and/or remain in the market because they obtain an innovator’s IP at less than the fair market price (either through theft or coerced transfer), they are able to siphon off sales that would otherwise go to innovators, thereby reducing the ability of innovators to reinvest in the next round of innovation.
via IP Protection: Access To Medicine Is Important But So Is Its Continued Improvement.
January 27, 2015
This new war between the drug giants seems unlikely to cease soon.
As for price-controls, if a large, private PBM like Express Scripts could secure a major deal pitting drug rivals against each other, it is strong evidence that, even in a patent-protected market, competition can work wonders. This outcome is, in fact, precisely what we pay insurers and PBMs to do—a job they generally do well.
via Want To Control Drug Prices? Reject Price Controls.
December 5, 2014
Over the past few years, several studies have indicated that drug makers and academic researchers fail to report results of clinical trials to a U.S. government website.
Only about 15,000 of the approximately 178,000 registered trials in the U.S.’s main database, ClinicalTrials.gov, currently include summaries of results, according to officials at the National Institutes of Health. That works out to a paltry 8%.
via What Happens When Results Data From Clinical Trials Goes Missing? – WSJ.
December 5, 2014
Industry groups praised the bill introduced Thursday by Sens. Michael Bennet (D-Colo.) and Orrin Hatch (R-Utah) that would exempt low-risk medical software and mobile apps from FDA regulation and provide greater regulatory certainty. The Medical Electronic Data Technology Enhancement for Consumers’ Health, or MEDTECH, Act joins a handful of other bills that would restrain FDA’s regulatory powers in the health IT domain. The act’s language is more focused than other Senate and House measures, and Hatch’s prominence and history of health care legislation immediately pushed the bill to the fore. Also, the MEDTECH Act hews more closely to the risk-based approach taken last spring by the FDA Safety Innovation Act work group. Its key element concerns clinical decision support software, which is often part of electronic health records and provides prompts to physicians based on research-based algorithms.
via Hatch-Bennet bill sharpens hill health IT focus — Feuding vendors join forces to make FHIR – POLITICO Morning eHealth – POLITICO.com.
November 28, 2014
The high nominal prices of new drugs do not compensate for the smaller patient populations that they target. Deloitte and Thompson Reuters estimate that the IRR internal rate of return of R&D spending has dropped in half since 2010, from 10.5 percent to 4.8 percent. Sales of new drugs are not overcoming the loss of patents, weak pricing power for older drugs, or reduced productivity of R&D.
via Crisis In Pharma R&D: It Costs $2.6 Billion To Develop A New Medicine; 2.5 Times More Than In 2003.
November 18, 2014
Developing a new prescription medicine that gains marketing approval, a process often lasting longer than a decade, is estimated to cost $2,558 million, according to a new study by the Tufts Center for the Study of Drug Development.
The $2,558 million figure per approved compound is based on estimated:
- Average out-of-pocket cost of $1,395 million
- Time costs expected returns that investors forego while a drug is in development of $1,163 million
Estimated average cost of post-approval R&D—studies to test new indications, new formulations, new dosage strengths and regimens, and to monitor safety and long-term side effects in patients required by the U.S. Food and Drug Administration as a condition of approval—of $312 million boosts the full product lifecycle cost per approved drug to $2,870 million. All figures are expressed in 2013 dollars.
via PR Tufts CSDD 2014 Cost Study | Tufts Center for the Study of Drug Development.