Independent Agency Rules — Week of May 12, 2025

On May 12, 2025, President Trump signed an executive order on prescription drug pricing that does something unusual: it directs the FDA Commissioner to consider revoking drug approvals as a way to pressure pharmaceutical companies to lower prices. The order, Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients, also tells the HHS Secretary to propose new pricing rules and instructs the FTC and Attorney General to take enforcement action against drug companies. The administration says the goal is to make prescription drugs more affordable for Americans.

This might matter if the FDA's drug approval process is perceived to be influenced by pricing considerations rather than science. The FDA's role is to determine whether medicines are safe and effective—a function designed to be insulated from political and economic pressure. Using the threat of pulling a drug's approval to win pricing concessions could affect public confidence in the independence of that process. A separate executive order from the same week, Fighting Overcriminalization in Federal Regulations, requires all agencies to report their enforcement rules to the White House budget office and discourages criminal enforcement of rules not yet reported—potentially increasing the White House's influence over how independent agencies enforce the law. The administration frames this as making regulatory enforcement fairer and more transparent.

There are important alternative explanations to consider. The most likely is that the drug pricing order is a negotiating tactic: presidents regularly issue ambitious orders on drug costs, and the "to the extent consistent with law" language may prevent the FDA from actually revoking approvals for pricing reasons. The revocation provision could also be read narrowly—as directing a review of questionable approval pathways rather than threatening to pull safe drugs. On the overcriminalization order, the underlying goal of reducing unfair strict-liability criminal penalties has broad bipartisan support; the concern is about the specific mechanism of White House oversight, not the reform itself.

Meanwhile, in Congress, a new bill would restructure the Consumer Financial Protection Bureau from a single-director agency to a commission—a change that could bring diverse perspectives to the agency's leadership but also arrives amid broader efforts to reshape independent agencies. A senator also raised alarms about the Department of Energy eliminating 47 regulations simultaneously.

Limitations: This analysis is based on AI review of official documents. The drug pricing order's actual impact will depend on agency implementation and potential legal challenges, neither of which is yet observable.