FDA Lawyers Want to Regulate Florida Pharmacy Errors

In previous blogs, I have written extensively about how Franck’s Pharmacy caused the overdose and death of 21 polo horses in Ocala Florida. As a result, the FDA tried to require preapproval each time a pharmacy wants to mix medicine, a process known as compounding, for all non food producing animals. The FDA appears to be trying to prevent this type of pharmacy error from occurring in the future. However, its decision would make it very difficult for pharmacies to profitably compound. In September, a federal judge ruled the FDA does not have jurisdictional authority over veterinary compounding and therefore could not impose the requirement. The FDA attorneys have now appealed the ruling to a higher court in hopes of overturning the trial judge.

PR Newswire reports the International Academy of Compounding Pharmacists (IACP) has recently called the appeal a waste of taxpayers’ money. According to IACP President John Herr, “The FDA again refuses to recognize that both the U.S. Constitution and the U.S. Congress limits its role in the state governed practice of medicine and pharmacy – a practice rightfully regulated by the state Boards of Pharmacy.” Mr. Herr was referring to the fact that in 2004 the U.S. Congress passed a law that supposedly addresses this issue. Apparently the FDA lawyers disagree.

This case is a classic battle over how much power non elected officials in federal agencies have to use their regulations to prevent activities not regulated by the U.S. Congress. Traditionally, only the U.S. Congress has the power to pass federal laws. However, when government agencies like the FDA were created, Congress gave them the power to pass regulations within pre approved parameters. The question here is whether the FDA is exceeding the power Congress gave it in the 2004 law referenced by Mr. Herr.

This case is also a classic battle over whether the federal government should have the right to tell state government what to do. The very fabric of our country was weaved together based on the idea of a limited federal government. According to the U.S. Constitution, states were to have the power to regulate their people and the federal government would only have the power to step in when the matter affected interstate commerce. Unfortunately, the concept of interstate commerce has been expanded by the courts to the point that federal agencies believe they have the right to regulate just about anything that was traditionally left up to the states. Here the state of Florida is apparently fine with allowing pharmacies within its state to compound medicines for animals, yet the federal government wants to create a national standard that is more restrictive.

Only time will tell how the courts ultimately sort this one out. However, at least for now the pharmacies appear to be winning this battle.


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