FDA Disclaimer

Recently, a landmark ruling in Midland, Texas, reinforced the view of the pharmacy profession that compounded medicines are not new, unapproved drugs and, subsequently, it is legal to prescribe and dispense them.

The Midland decision stops the FDA’s encroachment on the authority of state boards of pharmacy in its tracks and lifts the veil of uncertainty from pharmacy compounding, allowing pharmacists to serve their patients confidently.

FDA’s lengthy legal briefs against compounding can be boiled down to a very simple argument: that every compounded drug is a new, unapproved drug and, hence, subject to FDA oversight. FDA’s argument primarily hinges on one statutory provision in the FDC Act. This provision defines a new drug as “any” drug that is not generally recognized as safe and effective by experts. FDA argues that the word “any” is clear, simple, and unambiguous, and precludes examining any historical facts.

The problem with FDA’s argument is that the courts have repeatedly rejected it – even before the Midland decision. Recently, the U.S. Supreme Court reviewed a federal statute that imposed restrictions on individuals who had been convicted by “any” court. The government argued there, as the FDA argues here, that “any” means “every” and there are no exceptions. The Supreme Court rejected the government’s argument in that case, ruling that a Japanese court was not “any” court for purposes of interpreting the law. In other words, the Court said that courts should not read the word “any” literally as meaning each and every, and should not ignore, as the government wanted, Congress’ objectives and the historical context.

This is not a new concept. The U.S. Supreme Court in this decision cited another Supreme Court decision involving the word “any.” Thus, FDA’s central argument about how statutes must be interpreted – that the phrase “any drug” means every single drug, without qualification – flies in the face of judicial precedent going back two centuries.

FDA has cited no facts to support its position. Instead, FDA relies completely on this statutory argument. However, the facts refute FDA’s view.