For states, FDA’s compounding memo is all stick, no carrot

Agency ignores concerns by states and pharmacy groups, and patients pay the price

With the FDA not addressing concerns raised by states and pharmacy groups, patients across the country are facing a devastating loss of access to compounded medications, Griffith writes.  (Universal Images Group via Getty Images file photo)
With the FDA not addressing concerns raised by states and pharmacy groups, patients across the country are facing a devastating loss of access to compounded medications, Griffith writes. (Universal Images Group via Getty Images file photo)
Posted October 16, 2020 at 1:47pm

Thousands of patients throughout Virginia’s 9th District and across the country rely on customized medications prepared through a process known as compounding because manufactured drugs are unable to meet their specific need. Pharmacists with the skills and equipment necessary to compound drugs do not work in every corner drugstore; they are specialists, sometimes serving large geographic areas.

Unfortunately, recent actions by the Food and Drug Administration have cast doubt on the future of patients’ access to these customized medications.

When Congress added Section 503A to the Federal Food, Drug and Cosmetic Act in 1997, it directed the Food and Drug Administration to come to an agreement with the states — a memorandum of understanding, or MOU — to help “address … the distribution of inordinate amounts of compounded drug products interstate.” The MOU would incentivize states to gather data on pharmacies shipping a large percentage of compounded preparations out of state, so the FDA could properly inspect and document patient safety in those pharmacies.

The legislation offered states a carrot and a stick. They could sign the MOU and agree to report to the FDA those pharmacies that shipped more than 50 percent of their compounded products out of state (the carrot). If they did not sign, in-state pharmacies would be limited to shipping no more than 5 percent of prescriptions out of state (the stick).

Congress’ well-documented expectation was that the FDA would structure the MOU in a way that would entice states to take the carrot. Such an administrative regime could support the agency’s safety monitoring practices while allowing state boards of pharmacy, which are funded and regulated by state legislatures, to retain autonomy.

The FDA has had 23 years to solicit input from states and create that MOU. Unfortunately, the “final” MOU, released by the agency in May, fails to address concerns raised by states and pharmacy groups. Several states are threatening not to sign, an outcome that may result in a devastating loss of access to compounded medications.

Consider, for example, a highly specialized compounding pharmacy based in Michigan and serving patients in Virginia, Louisiana and Oregon. If Michigan doesn’t sign the MOU, that pharmacy would be severely restricted in serving those patients (who likely don’t have a local source for their treatment, else they wouldn’t be using an out-of-state pharmacy).

It may have local impacts too. Look at the twin cities of Bristol, Virginia, and Bristol, Tennessee: They are literally divided by the state border running down the middle of the street in the historic commercial center of the community. If either state chooses not to sign the MOU, patients on one side might be restricted from acquiring a product from their local pharmacy on the other side.

States also risk economic consequences.

Two states have already announced they will not accept the proposal, and many others have expressed hesitation. Based in one of these states is a compounding pharmacy that employs about 120 locals. The pharmacy is licensed in all 50 states. It performs exclusively nonsterile, patient-specific compounding, and ships about 95 percent of production out of state.

Because of the 5-percent cap, that pharmacy is out of business the moment the FDA’s MOU requirement takes effect. Those 120 local jobs? Lost. Maybe the owner will relocate his pharmacy to a state that signs the MOU, but that is an expensive proposition.

The FDA would likely blame the state for making that choice. But a choice between two bad alternatives is not what Congress intended. Rather than a carrot and a stick, states have been offered a stick and a two-by-four.

The steady flow of congressional reports and letters to the FDA since 1997 makes clear what Congress desired. Protecting Americans by ensuring the quality and safety of compounded medication? Absolutely. Presenting states with a nonnegotiable lose-lose proposition that jeopardizes patient access to medication and may kill jobs? Hardly.

The FDA could correct course by withdrawing its MOU and creating an administrative regime acceptable to states. It could listen to input from pharmacy groups about definitions in the MOU that don’t comport with applicable law and then work collaboratively to strike a balance between reasonable regulation and patient access.

There is still time to cultivate the carrot Congress intended. Patients in Virginia’s 9th District and across the country are counting on the FDA to get this right, lest the agency find itself facing costly legal challenges that would further delay its ability to do what Congress wants.

Morgan Griffith is a Republican representing Virginia’s 9th District. He serves on the House Energy and Commerce subcommittees on Health, Energy, and Oversight and Investigations.