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Unapproved drugs and consumer understanding

By Rebecca Tushnet

A big issue in the FDA/Lanham Act overlap is the extent to which consumers receive a message of FDA approval simply through seeing that a drug is on the market. Here's a NYT story about a big move in the market for nitroglycerin pills with further anecdotal evidence that the answer is yes:

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.

?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.

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.

Full post as published by 43(B)log on March 27, 2010 (boomark / email).