WARNING: This is a very different post than I have published, but it is a pointed, gut reaction to the blizzard of executive actions, announcements, and directions of the new presidential administration. Comments and feedback are always welcome.
We’ve lived through chaotic week 1 of the new presidential administration, we’ve seen new and escalating turmoil in essentially all departments of the federal government. I guess the best thing that could be said for Trump’s performance is that he gets an A+ in disruption; he still earns an F in understanding the consequences of his actions.
President Trump has continually signaled that he knows better (or more). We cannot forget that he was responsible, in his first administration, for urging Congress to repeal the Affordable Care Act without any plan to replace it and ensure coverage for more than 10 million people.
Most of his actions in the first seven days betray a further lack of understanding of their consequences. Each individual executive order or appointment he makes appear to be based solely on the expectation of economic gain or growth, or the deregulation of industries that absolutely require governmental regulation and reliable guard rails.
Deregulation
The view that industry leaders or lobbyists are best qualified to regulate an industry is nonsensical. And there is little evidence that industries can regulate themselves. This is based on years of hard-earned experience (e.g., toxic waste dumping, oil spills, train derailments, financial market investing, among many others). We might not need additional regulation, but we do need to assure that parties adhere to the ones we have.
The administration’s sledgehammer attempt at wiping out regulations across industries will risk repeating the errors of the past—some of them horrific—and all of them preventable. No one wants to live through another Love Canal or thalidomide episode. Isn’t this why the lattice of regulations was constructed? If we are to prevent the toxic side effects of a newly approved drug from outweighing any potential benefit, we need an independent and focused FDA. It can be argued that the FDA doesn’t currently regulate the health care and food supplement industry enough.
If we want to protect against another environmental catastrophe perpetrated on our land and its people, we need an independent and experienced Environmental Protection Agency. If we want excellent coordination between the federal government and states and with other countries, we need a fully equipped and funded Centers for Disease Control and Prevention and National Oceanic and Atmospheric Administration.
From the health care standpoint, a better focus on “deregulation” would be to streamline biosimilar development, based on the established science, and to speed their commercialization through the maze of drug patents.
Destruction of Institutional Knowledge and Expertise
I have not yet come to grips with the Supreme Court’s decision to ignore the authority of government agencies, long established in precedent as the Chevron deference. Government agencies should be able to establish necessary rules and regulations without congressional assent. Neither Congress nor the justice system are better qualified to make technical judgments than experts who have specialized in these fields. In fact, they are unqualified in most instances, and Congressional votes may be too influenced by lobbying and special interests to be considered in the public’s interest.
A Conflicted Commission on Efficiency
Today, the Department of Government Efficiency (DOGE), headed by billionaire Elon Musk, is seeking to cut trillions of dollars from the federal budget. This effort sounds reasonable, but the initial savings target is on cutting benefits to the poor and less-enfranchised—Medicaid. Furthermore, the administration will likely not renew federal subsidies for the Affordable Care Act, which enable larger segments of the population, including the middle class, to obtain coverage through the marketplace or through Medicaid expansion.
Ironically, one of the most obvious targets for the DOGE is the Department of Defense, but that seems sacrosanct; in fact, Republican lawmakers want to increase, not decrease, expenditures, for a military that is far better funded than in any other nation. The military and DoD are primary clients of SpaceX, which is Elon Musk’s highly profitable company. The DoD needs far more efficiency, not more dollars! I cannot see how the DOGE doesn’t address this issue, if it is to fulfill its mission. And I don’t see how Mr. Musk will view it in his own corporate interest to cut DoD dollars.
The DOGE will no doubt make highly controversial and debated recommendations, but note that these are recommendations only: Congress still holds the power of the purse. Indeed, it is less a department of the federal government than a commission. And commission recommendations are not often implemented.
What of the IRA?
The Trump administration has also indicated its willingness to reevaluate and perhaps repeal elements of the Inflation Reduction Act (IRA). It’s too early to tell whether these efforts will be focused on the Medicare drug price negotiation, Medicare part D redesign, or other health-related components of the IRA. These too cannot be changed by presidential fiat, only by an act of Congress. However, the Medicare drug price negotiation provisions rely on the activities of the Department of Health and Human Services, and these can be slow walked or ignored as a practicality. Therefore, even if changes are not made to the legislation itself, the intent of the legislation may be ignored, or worse, subverted. This depends on not only the leadership of those departments but the career staff at CMS, FDA, National Institutes of Health, and other health-related organs of government.
Trump’s extremely short-sighted decision to pull out of the World Health Organization (WHO) benefits no one, especially not the United States. Sharing of information about contagious infections is vital to public health. His aversion to public health, as demonstrated by his own actions during the COVID-19 pandemic, and his antipathy towards science in general (e.g., climate science [demonstrated by his desire to close down NOAA], cut funding to NIH, among other stated desires) further distance himself from facing facts.
I’m not sure what the effects of the WHO withdrawal decision will be in terms of global harmonization of drug regulations and approval processes as they regard biosimilars, but it certainly won’t make it easier to accomplish this goal, which is a keystone to improved efficiency in drug approval and development processes.
Will the Dust Have a Chance to Settle?
It will be weeks, if not months, before we settle on what will definitely occur, what will be challenged throughout the court system, and what will be put aside for future debate. Each will result in unending controversy, deliberation, and debate. I can only hope that the most malicious and wrongheaded of these efforts are themselves ignored or slow walked by long-time staffers who are motivated not by politics, power, or blind fealty to a leader, but to the principles of public health and the welfare of the population.
