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FDA Moves to Eliminate Custom Medicine

FDA Moves to Eliminate Custom Medicine
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This rule will make it harder for you to get the customized medications you need. Action Alert!

As part of its effort to implement the Drug Quality and Security Act of 2013, the FDA has taken the next step to implement a bad policy that will limit the amount of medicines like bioidentical hormones compounding pharmacies can send out of state, even when patients have a doctor’s prescription. This policy makes it harder for patients to get the medicines they need.

Last month, the FDA made available the final memorandum of understanding (MOU) with states regarding the interstate distribution of compounded drugs. It is largely unchanged from the last iteration of the MOU that was released late last year.

This rule concerns how much medicine traditional compounding pharmacies can send out-of-state. 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.

Previously, pharmacies in states that signed the MOU could send 30% of their sales interstate, but the FDA has increased that number to 50%. In an earlier proposal in 1999, the number was 20%. It is good that the number has increased, but these changes also highlight the arbitrary nature of this process. Why not 60%, or 80%? Why set any limit?  Does the FDA know what it’s doing at all?

Importantly, the final MOU does not address a key issue, which is that it 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.

Why does this distinction matter? Limiting the interstate shipment of compounded medicines pursuant to a doctor’s prescription will prevent patients from getting the medicines they need. Certain pharmacies specialize in specific areas, such as bioidentical hormones. 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% of their sales out-of-state, you’d be out of luck.

The same goes for any number of crucial medicines for vulnerable populations. One of the main purposes of compounded medicine is so that patients with allergies, patients who have difficulty swallowing pills, patients who require specialized formulations not available elsewhere, such as autistic children, or patients who require other modifications to the dietary ingredients and medicines available in the market can get the individualized treatments they need. An FDA-approved product may have peanut oil in it, so patients could go to a compounding pharmacy to get a peanut-free medicine. Limiting out-of-state sales for these pharmacies severely limits the options for patients who already have limited options.

Remember, too, that the 50% limit will only apply in states that actually sign the MOU—otherwise the 5% limit applies. Early indications are that many states will not sign the MOU. In a comment submitted to the FDA, the National Association of Boards of Pharmacy reported that 20 states informed them that they would be unwilling to sign the MOU in its current form, meaning that if the MOU is not revised, almost half the country will be subjected to the FDA’s draconian 5% interstate shipment limit.

All of this is happening simultaneously while the FDA threatens to eliminate consumer access to compounded bioidentical hormones such as estriol and progesterone. These and other hormones have been nominated to the agency’s “Difficult to Compound List”; items that appear on the final list will not be able to be compounded at all. You can read our previous coverage for more details.

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 have to fight back and ensure that patients can get the medicines they need.

Action Alert! Write to FDA with a copy to Congress, telling them to follow Congressional intent and stop limiting the interstate shipment of compounded drugs pursuant to a doctor’s prescription. Please send your message immediately.

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