Aloe Vera Health Benefits: Here We Go Again: FDA Defies Congress

Tuesday, January 10, 2017

Here We Go Again: FDA Defies Congress

And hobbles your doctor. Action Alert!

In the waning days of 2016, the US Food and Drug Administration (FDA) ignored the expressed will of Congress. The agency completed a “guidance” document that prohibits traditional compounding pharmacies from stocking doctors’ offices with custom drugs.

In December 2015, Congress included a provision in an end-of-the-year spending bill ordering the FDA to issue a guidance document clarifying how physicians and compounding pharmacists could continue the “office use” of drugs. These are custom drugs that a doctor keeps on hand for immediate treatment use. Congress could not have been clearer: the agency was not to forbid office use. The FDA has now answered—by ignoring it.

The FDA now wants the doctor to have to prescribe the drug—to have it compounded separately for each patient, and then administered on follow up visit. This is not only dangerous for patients who need immediate treatment. It also vastly increases the cost of the drug, wastes patient and doctor time, and is gross interference with the practice of medicine, which is supposed to be regulated by the states, not the federal government.

It’s increasingly obvious the FDA is a rogue agency unaccountable to the American people and the elected officials chosen to represent them. The FDA’s action is the latest evidence to support our long-held contention that the agency’s real goal is to eliminate traditional compounding pharmacies altogether. We think the agency wants to force all traditional facilities to register as outsourcing facilities, because under recent legislation, what can be compounded at outsourcing facilities is completely at the FDA’s whim, and can also be very narrowly defined. We can also expect the surviving pharmacies to be owned by Big Pharma.

We must not let the agency get away with this.

Action Alert! Write to Congress and voice your disapproval of the FDA’s thumbing its nose at Congress—and offer your support for compounding pharamacies.