Will Aspirin Become the Next Epipen?
Aspirin is grandfathered from all the FDA silliness, right? That's what I thought until this:
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.
I can't think of anything about the situation in nitroglycerin that doesn't obtain for aspirin. By this, all it would take would be for one company to have the cojones and cash to get FDA approval for their aspirin and they might be able to wield a monopoly.
