Tuesday, January 10, 2017

Many roadblocks limit our nation’s medical innovators and entrepreneurs, and Congress can remove them

...Many roadblocks limit our nation’s innovators and entrepreneurs, some of which could be removed rapidly by Congress, especially when there is already broad, bipartisan agreement to do so. Perhaps no better example of this would be the permanent repeal of the disastrous medical-device excise tax. This monstrosity, a provision of the Affordable Care Act, was a dark cloud over medical-technology innovation during the years it was in place and led to drastic cuts in R&D, job losses, and lost opportunities to improve patient care. Congress recognized how detrimental this policy was to innovation and suspended the tax for two years, but if nothing is done, it will resume in 2018. Fully repealing the medical-device tax once and for all — which has been spearheaded by Representative Erik Paulsen (R., Minn.) — is a commonsense approach that would remove a massive obstacle to improving patient outcomes and the creation of high-tech manufacturing jobs.

Most of the burden of stimulating R&D and getting new diagnostics and drugs into the marketplace will fall to the executive branch. In the Trump administration, we can expect a new head of the FDA, one of the 4,000 or so sub-cabinet-level political appointees. The post of FDA commissioner is one of the most important in the government because the FDA regulates products worth more than $1 trillion, 25 cents of every consumer dollar. Those products, which encompass food, drugs, vaccines, medical devices, and your dog’s flea medicine, affect every American in innumerable ways every day....

The analysis and debate will continue over what the 2016 election meant and how it will impact the future of policymaking, especially government regulation. Congress has already seized the initiative, attempting to reassert its oversight over the executive branch: The REINS Act, passed by the House last Thursday, would require congressional approval of all new major regulations, and the House’s controversial revival of the “Holman rule” would permit Congress to slash the pay of individual federal workers guilty of gross negligence or incompetence.

What there can be no debate about is that we need to address the persistent health challenges facing America, while also creating good jobs for a workforce that yearns to be a part of the dynamic 21st century.