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As part of its effort to implement the Drug Quality and Security Act of 2013, the FDA is poised 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. There is a Congressional sign-on letter being circulated urging the FDA to delay the implementation of this rule—we must urge our representatives in Congress to sign on to this letter.

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Support sign-on letter delaying compounding MOU

Dear [Decision Maker],

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As part of its effort to implement the Drug Quality and Security Act of 2013, the FDA issued a revision of a bad policy that will limit the amount of medicines compounding pharmacies can send out of state. The revision offers some improvements, but still makes it harder for patients to get the medicines they need. This benefits Big Pharma at the expense of the consumer. As a constituent who cares about access to compounded medications, I urge you to consider signing on to the letter led by Reps. Cuellar and Dunn asking the FDA to delay implementation of the MOU.

The rule concerns how much medicine traditional compounding pharmacies can send out-of-state. These sales are limited to 5% unless a state enters into a Memorandum of Understanding (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 include any limit?  Does the FDA know what it's doing at all?

Importantly, the revised 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 that pharmacy is 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.

For these reasons, please sign on to the letter from Reps. Cuellar and Dunn asking the FDA to delay implementation of the MOU so states have more time to make a decision on signing the MOU.

Sincerely,
[Your Name]
[Your Address]
[City, State ZIP]
[Your Email]