By Bhanvi Satija and Michael Erman
NEW YORK, May 15 (Reuters) - Bayer
Pharmaceuticals' chief operating officer said the head of the
top U.S. drug regulator recently reassured industry executives
that the Food and Drug Administration would meet its targets for
reviews despite recent job cuts and a restructuring.
"We're looking at an FDA and scientific review staff that is
stable, engaged and meeting its deadlines," Sebastian Guth, who
oversees Bayer's U.S. operations, said in an interview.
Guth said that after a recent meeting between FDA
Commissioner Marty Makary and industry executives, he was
confident that the leadership wanted to maintain the agency's
standards. Makary said last month the FDA will meet its targets
for completing reviews of new drugs despite mass firings under
the Trump administration.
Reuters had reported in early April that firings at the FDA
included employees critical to reviewing new medicines.
"I heard an FDA commissioner who notes and acknowledged that
the industry requires a stable and predictable regulatory
environment," said Guth, adding that Makary underlined his
intent to use technology to support FDA's work.
The FDA is expected to decide whether to expand approval
for Bayer's kidney disease drug Kerendia to patients with heart
disease this year.
Guth said Bayer's interactions with the FDA, predominantly
its Center for Drug Evaluation and Research, had followed tight
protocol and the agency had met its deadlines for experimental
drugs under review.
"We've seen the FDA responding within the timelines that are
to be expected," he said.
Bayer's experimental drug, elinzanetant, for treating
menopause symptoms, is also under review.
Guth said Bayer's first-quarter sales growth in the U.S., a
key market, exceeded the 23% rise for North America reported
earlier this week. Bayer does not break out sales by country.
The U.S. accounted for a "significant chunk" of its sales of
new prostate cancer drug Nubeqa and kidney treatment Kerendia,
he said. On Tuesday, the company reported a combined 680 million
euros ($760.51 million) in revenues from both drugs.
($1 = 0.8941 euros)