Concerns Over Regulatory Backsliding in Drug Oversight: Experts Comment on Trump’s New FDA Commissioner

1) Lowering standards and accelerating drug approvals. He believes the FDA places excessive emphasis on statistical certainty regarding drug efficacy and safety, severely impeding new drug approvals. He supports lowering Phase III clinical trial requirements. In a 2012 article, he criticized the FDA’s requirement that clinical trials for a new drug treating Hunter syndrome—a rare disease—enroll at least 96 patients and include a placebo group. Since this would require participation from 20% of all U.S. patients with the condition, it significantly delayed the drug’s market entry. 2) Supporting off-label use and promotion of drugs. He criticizes the FDA for lacking confidence in physicians’ judgment and imposing overly stringent drug regulations, advocating instead for greater physician autonomy in prescribing. 3) Relaxing regulation of generic drugs. He argues that high drug prices stem not from expensive innovative or specialty therapies, but from insufficient competition among older drugs. This lack of competition, he contends, results from overly burdensome regulation—raising generic drug development costs from $1 million historically to $20 million today. 4) Focusing FDA oversight on high-risk products. He believes the FDA devotes excessive resources to regulating low-risk medical products—such as mobile health apps and medical electronic devices—and should instead concentrate on high-risk areas like gene editing and stem-cell regenerative therapies, delegating oversight of low-risk products to other agencies. 5) Enhancing FDA transparency. He supports public disclosure of communications between pharmaceutical companies and the FDA, as well as public explanation of FDA reasons for rejecting drug applications—so other firms can avoid repeating the same mistakes. 6) Opposing Medicare price negotiations with drug manufacturers. This view contradicts Trump’s position. During his campaign, Trump proposed allowing the federal government to negotiate drug prices directly with manufacturers—a stance supported by Democrats. But Scott Gottlieb argues such negotiations would undermine pharmaceutical innovation. 7) Opposing importation of cheaper drugs from Canada, Mexico, and Europe. Another point of divergence from Trump. He contends that regulatory costs associated with importing drugs would offset any price savings, and that other countries would not supply cheaper medicines to the U.S. 8) Reforming drug manufacturers’ ‘rebate’ policies. He believes manufacturers should publicly offer discounted prices to intermediaries and insurers upfront, rather than relying on post-sale rebates. Under the current rebate system, uninsured patients are forced to pay full list prices for expensive drugs. Overall, Scott Gottlieb clearly serves as a spokesperson for the U.S. pharmaceutical industry. The central theme is deregulation and protection of U.S. pharmaceutical companies’ interests; even his occasional critiques of high drug prices are superficial and evasive. For example, attributing high drug prices solely to insufficient competition among older drugs lacks merit. Although generics account for 90% of prescriptions in the U.S., they represent less than 30% of total drug spending—meaning even rock-bottom generic prices would have negligible impact on overall drug cost containment. Likewise, shifting from rebates to upfront discounts would affect only the small segment of uninsured individuals. Of course, we cannot automatically conclude these positions necessarily harm patients’ interests. In many cases—and over the long term—pharmaceutical companies’ interests align with patients’ interests.

HPC Intelligence │ FDA Regulatory Updates: September 18–October 8, 2026 — Proposed Commitment Letter for BsUFA IV Includes Major Changes: Elimination of BPD Initial, Annual, and Reactivation Fees; Consolidation of BIA into BPD 2b

On September 24, 2026, the FDA released the proposed commitment letter for the Biosimilar User Fee Act IV (BsUFA IV), outlining several significant reforms to the current biosimilar review program aimed at improving review efficiency and reducing development burdens. Key changes include: consolidating the six supplemental application categories under BsUFA III into two categories (Category 1 with a four-month review timeline, Category 2 with a six-month timeline); introducing an ‘imminent action’ mechanism, allowing the FDA to continue addressing late-emerging but resolvable issues beyond the target date—thereby avoiding unnecessary complete response letters; eliminating initial, annual, and reactivation fees for Biosimilar Product Development (BPD); implementing tiered application fees for sponsors submitting multiple BLAs containing substantially identical active ingredient information, to encourage simultaneous submissions; discontinuing the Biosimilar Initial Consultation (BIA) meeting and replacing it with a Category 2b meeting as the initial interaction; launching a CMC Facility Lifecycle Program, offering a single pre-submission CMC facility meeting option; and proposing termination of the BsUFA Regulatory Science Pilot Program. Additionally, the previously proposed cap on the number of Reference Product Exclusions (RPEs) per year has been removed from the final agreement. The commitment letter was published alongside a Federal Register notice, and a public meeting is scheduled for October 26, 2026. FDA Recruits New Advisory Committee Members, Signaling Renewed Emphasis on External Expertise On September 30, 2026, the FDA issued two notices soliciting nominations nationwide for subject-matter experts and consumer representatives with scientific, technical, and professional backgrounds to join its advisory committees. This move signals the FDA’s renewed prioritization of external advisory expertise following perceived weakening of the advisory committee system under prior leadership. Acting Commissioner Kyle Diamantas stated the initiative aims to provide independent scientific expertise and rigorous scrutiny to FDA reviews. By contrast, under former Commissioners Makary and Kennedy, advisory committee meetings were drastically curtailed in 2025; only nine meetings occurred in 2026, and Kennedy replaced the entire membership of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) while convening five expert panels outside the formal committee structure—sparking concerns about political interference. Regulatory consultant Steven Grossman noted that issuing a press release—not merely a routine notice—carries important symbolic weight, indicating the FDA’s serious recommitment to advisory committees. Nominee Heidi Overton, during her confirmation hearing, likewise emphasized advisory committees as a cornerstone of her anticipated tenure. The FDA continues to accept applications: consumer representatives must apply by November 15, and subject-matter experts by November 30, for priority consideration; applications received thereafter will be considered only upon vacancy. Data Platform Atlas Compliance Analysis: Why FDA Frequently Deems Form 483 Responses Inadequate According to analysis by data platform Atlas Compliance, among the 267 warning letters issued by the FDA between January 2025 and August 2026, 224 (83.9%) indicated that the agency found the company’s prior responses to inspection observations at least partially inadequate. These rejected responses encompassed 671 individual deficiencies, grouped into 193 distinct compliance themes.

As FDA Awaits New Chief, Concerns Rise Over Role of Science Advisers

2 days ago

Amid uncertainty over the FDA's next leadership, concerns emerge regarding the influence of its 50 scientific advisory committees on critical health regulations. These panels advise on diverse products ranging from vaccines and drugs to medical devices.

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2026-10-15

As FDA Awaits New Chief, Concerns Rise Over Role of Science Advisers

As FDA Awaits New Chief, Concerns Rise Over Role of Science Advisers

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