From Trump’s Warp Speed to the FDA’s Warp Stall

With his background in business, President Trump understands better than many of his predecessors the unnecessary regulatory barriers the government can put in the way of business activities that benefit customers, companies, and the economy. As someone with a long track record in real estate development, he will have had direct experience with lengthy permitting processes in real estate development and will not have enjoyed the experience.

The president has supported shortened permitting requirements in infrastructure development with major changes in the National Environmental Policy Act (NEPA); cut gas, LNG, and oil pipeline approval times; and enacted “One Federal Decision” policies to ensure coordination rather than chaotic overlapping when multiple agencies are involved in permitting decisions. The latter initiative was introduced by executive order in the first Trump administration; it was later revoked, while parts of it were adopted in several legislative permitting reforms. But there has been no equivalent deregulation for other forms of development, such as drug development at the FDA. The hope was that a deregulatory president like Trump would, in his second term, go after the barriers to innovation imposed by the FDA, just as he did so successfully with Operation Warp Speed in his first. Indeed, just before Covid-19 broke out, I was involved in extensive discussions between the White House and the FDA on a more ambitious deregulatory agenda.

The FDA’s record of delays and regulatory excess is, among government agencies, hardly unique, but that is no excuse. Likewise, drug development often takes more than a decade and costs more than $2 billion per approved drug, and approval delays can wreck the futures of many promising products. Imagine the effect of such delays for AI or software innovations. If such an approach had prevailed in the latter case, we would still be using our AOL accounts (my apologies to those who still are).

This excessive regulatory burden particularly hits small businesses in U.S. biotech, of which there are many. According to the 2023 Business Enterprise Research and Development survey, about 2,970 small firms are engaged in U.S. biotechnology research and development. This suggests that the Small Business Administration (SBA) should get involved through its Office of Advocacy, which has the role of making the legislative and executive branches aware of the concerns of small businesses faced with excessive regulatory burdens. Its services are badly needed to tackle an institution in which, despite the big game that is talked on deregulation, an entrenched culture of government-knows-best has consigned companies to a regulatory maze while they try to bring desperate patients the treatments they want.

There may be no better exemplar of red tape at the FDA than in the area of rare diseases, where patient need is so great that Congress has empowered the FDA with regulatory flexibility, market incentives, and numerous other agency-issued designations meant to speed development. Yet 2025 witnessed an increase in rare disease rejections and a decrease in approvals. This year looks just as bleak, with recent high-profile rejections and stalled programs both in common and rare disease for companies like Atara (developing Ebvallo for Pierre Fabre, a treatment for EBV + PTLD), Regenxbio (RGX-121 for mucopolysaccharidosis), Disc Medicine (bitopertin as a treatment for patients with erythropoietic protoporphyria), Capricor (deramiocel for cardiomyopathy in Duchenne muscular dystrophy), Replimune (Tudriqev, for melanoma), and others.

The case of Stealth Biotherapeutics shows us that orphan, “fast” track and priority review designations issued by the FDA are meaningless when overwhelmed by bureaucratic dysfunction. Stealth spent over eight years in clinical development for its drug Forzinity for Barth syndrome and had to endure three NDA submissions, one refuse to file (RTF) letter, two complete response letter (CRL) rejections, and two PDUFA date delays — all this despite an independent advisory committee voting 10–6 to approve its drug just before Stealth received a second CRL. The company barely survived near financial collapse and had to cut 30 percent of its workforce. After the FDA came under intense public scrutiny for rejecting this rare disease drug, the company was finally granted an accelerated approval for a very narrow indication but only with the promise to run yet an additional study.

A similar bureaucratic maze has faced Biohaven. Its data demonstrate that its Vyglxia (troriluzole) is the first drug to slow the progression of a life-threatening neurodegenerative disease, spinocerebellar ataxia or SCA, which currently has no approved treatment. Like Stealth’s Forzinity, Vyglxia met all the criteria for the FDA to speed approval, and no safety issues were raised in the SCA review. After nearly a decade of generating data, Biohaven was initially met with an RTF rejection and then a PDUFA delay after its second NDA submission. When the leading doctors involved with SCA wrote a letter to the FDA supporting approval for the Vyglxia, the FDA canceled the planned meeting of the advisory committee to consider the drug and then issued a CRL rejection. The company had to slash its R&D spend by 60 percent, and SCA patients who have been receiving Vyglxia under compassionate use, ironically approved by the FDA, are currently left in a desperate limbo.

It is time for the White House to take charge and protect patients from the terrible damage caused by this type of bureaucratic nonsense. The president previously backed 2018’s Right to Try Act which allows eligible patients with terminal diseases to try non-FDA approved investigational medicines cleared for safety but not efficacy. This law partly removes some of the adverse consequences of FDA delays, but vastly more needs to be done. Let’s hope the recent restructuring at HHS will provide greater speed and efficiency in the delivery of safe drugs for unmet needs. The promise of the president’s deregulatory agenda should deliver no less.