FDA Overreach on Hold, Temporarily

The FDA has delayed implementation of a bad rule that will limit access to customized medicines like bioidentical estriol and progesterone that millions of women rely on.

The FDA recently announced that it will extend by one year — to October 27, 2022 — the date on which it will begin enforcement of the Memorandum of Understanding (MOU) with states regarding interstate shipments of compounded medications. This is a direct result of ANH and other stakeholder advocacy on this issue. It is a significant victory as it will allow states more time to review and sign the MOU. Pharmacies in states that sign the MOU will be allowed to send 50 percent of their sales out-of-state, compared to a draconian five percent limit for states that do not sign the MOU. Whether states sign will have a dramatic impact on consumer access to important customized medicines.

Here’s how we got to this point. Last year, the FDA made available the final MOU with states regarding the interstate distribution of compounded drugs (compounded drugs are custom medicines made by specialized pharmacies tailored to individual patient needs). This rule concerns how much medicine traditional compounding pharmacies can send out-of-state. As mentioned above, these sales are limited to 5% unless a state enters into an MOU permitting additional sales.  In exchange, however, the state assumes some of the responsibility for overseeing pharmacies within their borders that send a certain amount of medicine to other states.

As a Congressional letter to the FDA pointed out, many states, including large states like Florida and Texas, indicated that they would be unable to meet the FDA’s original deadline to sign the MOU due to a number of factors, including limited legislative sessions and, of course, the disruptions caused by the pandemic.

An extension of the deadline to sign is a positive step, but it, of course, does not address the fundamental problems with the MOU. Chief among these is the fact that the FDA shouldn’t be limiting the interstate shipment of medicines for which there is a doctor’s prescription at all; the law only allows the FDA to place some limitations on how many medicines a traditional pharmacy can send out-of-state without patient-specific prescriptions.

Through this rule, the FDA will make it harder for you to get the medicine you need. If you get your estriol from a pharmacy in Michigan, and you live in New Jersey, there’s a real risk that you will no longer be able to get that medicine, even if you’ve taken it for years. If that pharmacy has already sent 50 percent of their sales out-of-state—of just five percent if Michigan didn’t sign the MOU–you’d be out of luck.

The same goes for any number of crucial medicines for vulnerable populations, like those with allergies, who have difficulty swallowing pills, or require specialized formulations not available elsewhere, such as autistic children.

As we’ve said all along, it is our opinion that the objective in all of this is to shut down compounding because it threatens Big Pharma profits, and Big Pharma funds the FDA. We should continue to keep up the pressure on the FDA to amend this flawed rule.

Action Alert! Write to Congress and the FDA, urging them to change the MOU to reflect the law and not limit interstate dispensing of compounded medicines. Please send your message immediately.