The FDA's Power Grab
But if the FDA gets its way, nitroglycerin will not be obtainable for pennies. The situation was stable until Pfizer went through the time and expense required to test its particular version of nitroglycerin, Nitrostat, which the FDA approved in 2000. Once the FDA did that, other versions became officially “unapproved.” In 2010, the FDA sent warning letters to two companies, Glenmark and Konec, ordering them to cease marketing their versions of nitroglycerin, known as sublingual nitroglycerin tablets, leading to the New York Times headline above. The article quotes Dr. Harry M. Lever, a cardiologist at the Cleveland Clinic, who said, “If it’s not approved and no one has tested it, we can’t be sure that it’s safe and effective.” He added that if patients with angina took substandard or ineffective nitroglycerin tablets, their pain might not subside and the problem could potentially progress to a heart attack.
His statement is false. The unapproved versions have been tested in three important ways: the companies that manufacture these drugs thoroughly vet them to make sure that they are pure and offer a consistent dose of nitroglycerin; these marketed drugs have been tested in the bodies of millions of Americans in regular medical practice over many years; and many different organizations have tested nitroglycerin in countless clinical trials.
One of the manufacturers, Konec, has regularly conducted its own lab tests to ensure that its nitroglycerin pills have the same potency and stability as Pfizer’s Nitrostat, the FDA-approved brand-name drug. In the world of medicine, this is basic stuff. Nitroglycerin is used to treat acute episodes of angina–chest pain. The benefit that nitroglycerin provides is not theoretical; if patients didn’t feel relief from their pain, they wouldn’t have continued taking it, and doctors wouldn’t have continued prescribing it for the last 130 years. (emphasis added)
This is from David R. Henderson and Charles L. Hooper, “The FDA’s Power Grab,” Defining Ideas, September 8.