Bayer US head says FDA chief reassured pharma executives of timely reviews

Bhanvi Satija and Michael Erman

Thu, May 15, 2025, 3:16 PM 2 min read

By Bhanvi Satija and Michael Erman

NEW YORK (Reuters) -Bayer Pharmaceuticals' main operating serviceman said the caput of the apical U.S. cause regulator precocious reassured manufacture executives that the Food and Drug Administration would conscionable its targets for reviews contempt caller occupation cuts and a restructuring.

"We're looking astatine an FDA and technological reappraisal unit that is stable, engaged and gathering its deadlines," Sebastian Guth, who oversees Bayer's U.S. operations, said successful an interview.

Guth said that aft a caller gathering betwixt FDA Commissioner Marty Makary and manufacture executives, helium was assured that the enactment wanted to support the agency's standards. Makary said past period the FDA volition conscionable its targets for completing reviews of caller drugs contempt wide firings nether the Trump administration.

Reuters had reported successful aboriginal April that firings astatine the FDA included employees captious to reviewing caller medicines.

"I heard an FDA commissioner who notes and acknowledged that the manufacture requires a unchangeable and predictable regulatory environment," said Guth, adding that Makary underlined his intent to usage exertion to enactment FDA's work.

The FDA is expected to determine whether to grow support for Bayer's kidney illness cause Kerendia to patients with bosom illness this year.

Guth said Bayer's interactions with the FDA, predominantly its Center for Drug Evaluation and Research, had followed choky protocol and the bureau had met its deadlines for experimental drugs nether review.

"We've seen the FDA responding wrong the timelines that are to beryllium expected," helium said.

Bayer's experimental drug, elinzanetant, for treating menopause symptoms, is besides nether review.

Guth said Bayer's first-quarter income maturation successful the U.S., a cardinal market, exceeded the 23% emergence for North America reported earlier this week. Bayer does not interruption retired income by country.

The U.S. accounted for a "significant chunk" of its income of caller prostate crab cause Nubeqa and kidney attraction Kerendia, helium said. On Tuesday, the institution reported a combined 680 cardinal euros ($760.51 million) successful revenues from some drugs.

($1 = 0.8941 euros)

(Reporting by Bhanvi Satija and Michael Erman successful New York; Editing by Richard Chang)