With the rallying cry of corporate greed, each year of the Biden-Harris administration has brought successive government interventions into the healthcare system, largely targeting the life sciences industry, including large companies. employing thousands of Americans, businessmen and the many creative and struggling small businesses driving breakthrough innovation. Through one-off administrative actions and partisan legislation, the Biden-Harris administration has stifled innovation and made it harder for new drugs to reach patients.

The Biden-Harris administration’s push for the Inflation Reduction Act of 2022 spawned an approach that many economists thought was dead, while others warned it was resurfacing: centralized price regulation. Administrative prices and inflation rebates for pharmaceutical manufacturers resurrected a dangerous centralized “command and control” economic model.

While government, congressional oversightand independent experts While assessing the magnitude of the negative impact of the IRA on innovation and development, other consequences remain to be understood. A static political intervention in a market desperate for dynamism, the IRA The expected savings are already estimated at less. than originally projected.

The impact on patients is real and is a policy issue that will be subject to long-term debate. Early modeling study by a group of economists from the University of Chicago found that drug price controls in an IRA-like legislative proposal would result in an estimated loss of $663 billion in research and development investments, resulting in at least 135 fewer drugs and more than 330 million years of life lost. Since the IRA was approved, the Life Science Tracker website notes that companies have disrupted 36 additional research programs and more than 21 drug development programs. In oncology alone, more than a dozen drug development programs have been disrupted, directly undermining Biden’s Cancer Moonshot initiative.

Additionally, private intellectual property is recently under threat, and the National Institute of Standards and Technology (NIST) has issued draft guide on the exercise of government entry rights. A response to the economic stagnation of the 1970s, 1980s Bayh-Dole Law was a historic bipartisan bill which facilitated the later private sector development of early government-funded research. It allowed innovators to retain ownership of patents when recipients of federal funds would have reflexively assigned intellectual property rights to the appropriate agency. Not surprisingly, Bayh-Dole catalyzed an explosion of federally funded research over the past 40 years. contributing $1.3 trillion for domestic production and support 4.2 million American jobs.

There is a warning. Bayh-Dole allows the government, under certain circumstances, to claim patent rights through what is called “marching rights.” However, Bayh-Dole did not sanction entry fees solely on the basis of price, precisely what the Biden-Harris administration has now proposed in an effort to ignore congressional intent. The exercise of entry rights would undermine the foundations of our national intellectual property system. Even the National Institutes of Health, the country’s largest public funder of biomedical research, refused to use this authority in 1997, 2004and again in 2023declaring that “the extraordinary remedy of entry into service is not an appropriate means of controlling prices.”

In one fell swoop, price-driven entry fees would weaken American biomedical innovation on a monumental scale. Universities, research institutions, and startups would think twice before accepting federal funding and limit their R&D budgets accordingly. Only the National Cancer Institute awards more than $5 billion in grants for cancer research In 2022, patients and their families will pay the biggest price for lost innovation.

Unfortunately, this is not all. With Halloween just around the corner, regulatory zombies are stalking many life sciences innovators under the Biden-Harris administration. At the beginning of this year, the FDA resurrected its latent authority regulate laboratory-developed tests (LDTs) like traditional medical devices. After nearly half a century of exercising enforcement discretion without advocating for widespread medical risk, the FDA chose to avoid compromise and subvert the will of Congress, rather than act independently to frustrate doctors by limiting availability. of diagnostic tests.

Diagnostic error is a long-standing clinical problem affecting patients, according to the National Academy of Medicine’s 2015 report on “Improving diagnosis in healthcare”Estimating that more than 20% of medical malpractice cases were associated with diagnostic errors. A late or incorrect diagnosis can also be fatal, with a autopsy review indicating that 10.2% of patients experienced diagnostic errors that may have affected their clinical outcome. He American Hospital Association reporting that a single health system had more than 1,600 LDTs ​​who would face $8 million in regulatory feeswhile another developed 150 new LDTs ​​in one year. The FDA’s LDT rule destroys bottom-up clinical innovation that would improve clinical performance for patients.

The last four years have been marked by a relentless campaign against scientific and clinical innovation. As the healthcare delivery industry suffers from centralized payments and overregulation, innovation in the life sciences remains a bright spot for Americans seeking healthier, more independent lives. It is essential that we protect it.

Dr. Vrushab Gowda is a Clinical Fellow at Harvard Medical School. Dr. Brian J. Miller is a nonresident fellow at the American Enterprise Institute and an associate professor of medicine at the Johns Hopkins University School of Medicine.