One of the ways that scientists traditionally measure the well-being of a nation is to track the rate at which its citizens die, and how long they can be expected to live. So the news out of the National Center for Health Statistics earlier last month was disturbing: The overall U.S. death rate has increased for the first time in a decade, and that led to a drop in overall life expectancy for the first time since 1993.
The finding is thought to be due to a confluence of issues, including more obesity in the population, increasing long-term unemployment, more patients with chronic diseases, and a lack of breakthrough innovations to reduce the costs of care while increasing the quality of life. But the new data certainly highlight the critical need to provide better life-saving and life-prolonging therapies for patients.
The 21st Century Cures Act is an example of smart policies spurring solutions to the nation’s problems. This commonsense legislation, signed into law last month, is the result of years of negotiations, compromises, and passionate advocacy among countless stakeholders, including patient groups, health-care providers, hospitals, the life-science community, regulators, and more. Although not perfect, the legislation will boost research into some of the most vexing medical challenges our health-care system faces, while making sure that there are expedited pathways coupled with new resources for medical innovators and regulators to get breakthrough therapies to patients without delay.
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.
Moreover, the FDA is a gatekeeper, which means that it must issue affirmative approvals of many classes of products before they can be marketed. And yet, appointments to this critical job have often seemed to be treated by presidents as something of an afterthought.
The current FDA commissioner, Dr. Robert Califf, assumed the position only in February 2016, so he has not really had time to make his mark. He reportedly has not been contacted by the Trump transition team and thus is on the way out. His predecessor, Dr. Margaret Hamburg, who was in place for seven years, is an exemplar of what we don’t want in the Trump administration.
Dr. Hamburg was intelligent and experienced in public health before her appointment to head the FDA, but she chose to be primarily a figurehead who traveled extensively and gushed constantly about her agency’s commitment to sound science and its superior performance, though the record often told a very different story.
Dr. Hamburg hewed to the wishes of her political masters even when they conflicted with science, federal law, and common sense. She also made inexplicable errors of judgment, neglected to crack the whip when her minions dragged their feet on approving important medicines and other products, and failed to exercise appropriate scrutiny over “compounded drugs.” Examples of injurious delays include vaccines for meningitis B as well as pirfenidone, a drug to treat a fatal disease called idiopathic pulmonary fibrosis. The delays in approving these products, which had been widely approved abroad before FDA sanctioned them, resulted in numerous preventable deaths in this country.
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.
— Henry Miller, a physician and molecular biologist, is the Robert Wesson Fellow in Scientific Philosophy and Public Policy at Stanford University’s Hoover Institution. He was the founding director of the Office of Biotechnology at the FDA. Twitter: @henryimiller