Leading cardiologists said they were shocked to learn that for years their patients might have been taking crucial heart drugs whose safety and potency had not been vetted by the F.D.A.
According to the FDA, these drugs have not been grandfathered. What do reasonable doctors/consumers think about grandfathering? This is an especially interesting question as the FDA now disagrees with the manufacturers' interpretation of the rules about these nitroglycerin pills.
“I was taken aback,” said Dr. Ralph G. Brindis, the president of the American College of Cardiology, a professional association representing nearly 26,000 cardiologists in the United States.
Dr. Harlan M. Krumholz, a professor of medicine at the Yale School of Medicine, said it would not have occurred to him that licensed pharmacies might be filling prescriptions with unapproved drugs. “Nobody ever teaches you that in medical school,” he said.