A heated dispute within the Food and Drug Administation on whether to put new lung-cancer warnings on leading blood-pressure drugs taken by millions of people is unlikely to have any significant effect on either the stocks of the drugs' manufacturers or their future sales, analysts said Friday.
The fight within the FDA, reported by The Wall Street Journal Friday, detailed how Thomas Marciniak—a senior regulator at the agency—had without success demanded that the FDA inform doctors and patients about the purported lung-cancer risks from blood-pressure drugs known as angiotensin receptor blockers.
Sales of ARBs—which include Diovan by Novartis; Avapro by both Sanofi and Bristol-Meyers Squibb; Cozaar by Merck & Co; and Micardis by Boehringer Ingleheim—topped $7.6 billion last year. Shares of the drug makers were trading lower Friday as the Dow tumbled more than 200 points.
"The FDA must act now," Marciniak wrote senior FDA officials, noting he had found raw data from patients in drug studies showing a 24 percent increase in the risk of lung cancer compared to patients taking placebos or other drugs, the Journal reported.
But the FDA refused to modify a finding first issued in 2011, which ruled there was no such increased risk of cancer from ARBs. FDA officials disputed Marciniak's methodology for analyzing that risk.