President-elect Donald Trump has announced that biotechnology executive and FDA critic Vivek Ramaswamy, along with controversial businessman Elon Musk, will head a new commission to slash federal regulations and slim down federal government spending, raising further concerns about potential rollbacks of rules and major staff cuts at FDA and other health agencies.
Ramaswamy said the commission would scrub rules dating back four decades, and before dropping out of the 2024 presidential race said he wanted to “gut much of FDA.”
The panel could be a booster for potential efforts to overrule FDA regulations published late in the Biden administration, and an ally in Republican lawmakers’ close scrutiny of FDA’s structure and the agency’s interpretation of vague laws. The cuts Musk and Ramaswamy are eying would likely lead to major government layoffs, coming as Trump is expected to revive a policy from his first administration that would decrease protections for staffers against politically motivated firing.
Trump announced Wednesday (Nov. 13) that the two executives would head what he called the “Department of Government Efficiency,” or DOGE, in an apparent reference to a meme-based cryptocurrency Musk was sued for promoting. The body will apparently be a non-government commission but work closely with the White House. Trump, during the election, vowed that if elected again he will dismantle the “deep state,” a term he has frequently used to refer to federal agencies like FDA.
In a statement posted on X, as Musk renamed Twitter after purchasing the social media site, Trump said Musk and Ramaswamy will “pave the way for my Administration to dismantle Government Bureaucracy, slash excess regulations, cut wasteful expenditures, and restructure Federal Agencies.”
Trump said the commission would provide advice from outside of government and would work with the White House Office of Management and Budget “to drive large scale structural reform.”
Trump said the work would be complete by June 2026.
Musk and Ramaswamy both made statements on the social media platform Musk owns, with Musk saying, “The world is suffering slow strangulation by overregulation. Every year, the noose tightens a little more. We finally have a mandate to delete the mountain of choking regulations that do not serve the greater good.”
He also posted that he would support ending government funding of nonprofit organizations.
Ramaswamy said the commission would scrub decades of rules, with Loper in the spotlight.
He said on the site that “eliminating bureaucratic regulations isn’t a mere policy preference. It’s a legal mandate from the U.S. Supreme Court: West Virginia v. EPA (2022) held that agencies cannot decide major questions of economic or political significance without ‘clear congressional authorization.’ This applies to thousands of rules that never passed Congress.”
Ramaswamy also cited the case Loper Bright v. Raimondo, in which the Supreme Court ended the principal of Chevron deference, saying it means “agencies can’t foist their own interpretations of the law onto the American people.”
Ramaswamy offered controversial interpretations of Loper Bright and other Supreme Court cases. Loper Bright, he said, means the 18,000 federal court cases that cited Chevron are “now null and void,” while SEC v. Jarkesy, another ruling the court issued in its most recent term, he said, means “the same agency that wrote the rules shouldn’t be able to prosecute citizens in ‘courts’ that it controls.”
Neither are the Supreme Court’s actual rulings but do represent interpretations that could be used to further limit federal agency powers, if courts go along with them.
Ramaswamy said the government efficiency commission, in aiming to roll back rules, “shouldn’t just look at rules passed in the last 4 years, but over the past 4 decades (or more).”
As a presidential candidate, Ramaswamy said he wanted to “ultimately gut” much of FDA. That’s a view shared by anti-vaccine activist Robert F. Kennedy Jr., who has become a top Trump health advisor. Kennedy recently said some entire departments at FDA, including nutrition regulators, “have to go.”
Possible conflict of interest concerns
Ramaswamy owns multiple FDA-regulated companies and has been an outspoken critic of the agency’s polices. Musk owns the FDA-regulated Neuralink, a developer of brain-computer interface devices, and multiple other companies, including some that are federal government contractors.
Sen. Elizabeth Warren (D-MA) pointed out in a social media post Wednesday (Nov. 13) that Trump has not yet signed documents required as part of the presidential transition process in legislation she sponsored, including an ethics pledge to avoid conflicts of interest.
The delay means the Trump transition team does not yet have access to support services through the General Services Administration. “This is what illegal corruption looks like,” Warren alleged.
It’s not clear whether the Trump administration or the incoming Republican-dominated Congress would do anything to protect federal agencies or their employees from retaliation by the two executives.
Current FDA chief hopes stakeholders defend agency
At an event hosted by the Friends of Cancer Research, FDA Commissioner Robert Califf was asked about whether FDA staffers would resign in response to Trump and Kennedy remarks on the future of the agency.
“We have to wait and see and have some faith that hard-working, high-quality people are going to still be in place, and will have support, I hope, from the external regulated community,” Califf said. “Getting into a back-and-forth about hypotheticals is not productive for anyone. I would just say I want to stand by the people who work at FDA. They’re good people. They’re hard-working and they want what’s best for the American public. I have no question about that.”
Ramaswamy’s FDA criticism
A biotech entrepreneur, Ramaswamy has been an intense critic of FDA. He ran a brief presidential campaign of his own before endorsing Trump. Ramaswamy founded the biotechnology firm Roivant Sciences and its subsidiaries, which have developed multiple successful drugs. In 2022, Roivant launched a partnership with pharmaceutical giant Pfizer.
Offshoots of the company include Axovant Sciences, which was initially successful but plummeted in value after its Alzheimer’s disease drug candidate failed to succeed in clinical trials.
In social media posts railing against FDA, Ramaswamy has written that “corrupt FDA says you don’t have the right to even try medicines that haven’t been through 10+ years of testing.” In an attached video, Ramaswamy said FDA “hates it and will penalize you if you actually avail yourself of those Right to Try laws.”
The Right to Try law signed by Trump aims to give terminally ill patients who cannot participate in clinical trials access to investigational drugs. Trump claimed on the campaign trail at the law had helped save thousands of lives, though evidence shows it has been used few times.
While Ramaswamy advocates Right to Try, Kennedy has said he would seek to return a “gold standard” of review to FDA. A former Trump official recently said that promise wouldn’t conflict with Right to Try.
As a candidate Ramaswamy said he would support ending federal funding of Planned Parenthood and that he would not make cuts to Medicare or Social Security.
“We need better healthcare in America — not sick-care. I see it first-hand every day because my wife is a surgeon. She wants to get her patients healthy with the full range of options: diet, exercise, preventative medicine. Yet all the system wants to pay for is more pills,” Ramaswamy said in December 2023. “Americans keep getting sicker. Only health insurance profit margins get healthier. The solution? End anti-trust exemptions for health insurance companies. Let the competitive marketplace flourish.”
Ramaswamy has also said COVID-19 vaccines were rushed through review and that FDA played a role in vaccine mandates, both untrue claims. “For years I was coached by industry veterans not to speak out against FDA,” Ramaswamy said on the Musk-owned X. ‘It’s well known that if you anger FDA, they will punish you by blackballing review of your drug review applications. ‘FDA never forgets’ is a quietly-whispered, well-known pharma industry adage.” — Jessica Karins (jkarins@iwpnews.com)
https://insidehealthpolicy.com/daily-news/trump-s-planned-ramaswamy-musk-commission-stokes-fears-major-fda-cuts
