Hatch-Bennet bill sharpens hill health IT focus — Feuding vendors join forces to make FHIR – POLITICO Morning eHealth – POLITICO.comDecember 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.
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.
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.
The majority of moderate- to high-risk medical devices approved by the U.S. Food and Drug Administration lack publicly available scientific evidence to verify their safety and effectiveness despite requirements in the law, according to a study released Monday.Researchers reported in JAMA Internal Medicine that 42 of 50 selected medical devices cleared by the FDA over five years lacked such data, despite a 1990 law calling for sufficient detail to justify their FDA clearance. The law calls for public data about studies, which may include clinical studies, involving human patients.
There’s growing frustration among entrepreneurs in Silicon Valley who are finding that the road to improving medical technology ends not in Palo Alto but in White Oak, Md.—at the headquarters of the Food and Drug Administration. “Health is just so heavily regulated,” Google co-founder Sergey Brin complained last month to a group of high-tech CEOs, “it’s just a painful business to be in.”The pain has become especially acute in the burgeoning field of mobile medical apps and health-care…
For decades, the FDA had chosen not to actively regulate laboratory-developed tests, or LDTs, because they tended to be simple devices used to diagnose rare or “low-risk” diseases. In recent years, however, the tests have become more widely used and more specialized, able to diagnose specific forms of cancer and other diseases with complex genetic data.Government regulators say the evolution makes it more critical than ever to ensure that the tests are safe and trustworthy and that patients who rely on them aren’t misdiagnosed. Several incidents in recent years have underscored those concerns, including instances in which the reliability of LDTs for cervical cancer, Lyme disease and whooping cough have been questioned.