October 26, 2020

FDA POSTS FINAL MOU: Disappointing … but not surprising

October 26, 2020

Scott Brunner, CAE


For pharmacy compounders, this morning’s action by FDA to post to the Federal Register a final but deeply flawed memorandum of understanding with states on interstate shipments of compounded medications is disappointing … but not surprising.

“At no point in the 23 years since Congress first directed FDA to create the memorandum has FDA shown the slightest interest in concerns raised by pharmacy compounders about how FDA’s structuring of the MOU could restrict access to compounded medications for thousands of patients who rely on them,” said Scott Brunner, CAE, chief executive officer of the Alliance for Pharmacy Compounding. “Not even input from members of Congress — delivered via phone call, letter, and committee reports accompanying FDA’s annual appropriation — have been able to slow an overreaching FDA. In fact, FDA seems more intent on getting its way than on crafting a workable solution for patients, for pharmacy compounders, and for state boards of pharmacy.”

FDA seems more intent on getting its way than on crafting a workable solution for patients, for pharmacy compounders, and for state boards of pharmacy.

In adding section 503A to the Food, Drug & Cosmetic Act in 1997, Congress directed FDA to draft a memorandum of understanding to incentivize states to help FDA gather data on shipments of non-patient-specific compounded medications across states lines so that FDA could inspect and document patient safety in those pharmacies. Congress clearly meant for FDA to structure the MOU in such a way that state boards of pharmacy would be motivated to sign it. It was not Congress’s intention to limit patients’ access to compounded medications.

“Unfortunately,” said Brunner, “The MOU FDA posted today places a significant — and unfunded — administrative burden on state boards of pharmacy. Those boards get their authority and funding from state legislatures, not from Congress, and many states are now threatening not to sign it. If states won’t sign, the enhanced patient safety measures Congress aimed FDA to achieve via the MOU can’t be realized.”

Pharmacies in states that don’t sign the MOU will be restricted to shipping out-of-state no more than five percent of all compounded medications they dispense — and because pharmacy compounding is not always a local business, patients outside states that don’t sign will find access to their medications cut-off. Not only that: In states that don’t sign, compounding pharmacies that ship the bulk of their patient-specific compounded drugs out of state may be forced to close their doors, eliminating jobs and a local economic engine in the process.

“This is not the choice Congress meant FDA to offer states: A significant unfunded mandate or a job-killing cap on shipments,” said Brunner.

“Rather than working with individual state boards of pharmacy to assess each state’s concerns about the MOU and the likelihood a state would sign it in its current form, FDA instead relied on representations by the National Association of Boards of Pharmacy that, however well-intentioned, do not reflect the views of many state boards,” Brunner said.

“In fact,” said Brunner, “All along, both FDA and NABP have seemed to be oblivious to the concerns raised by stakeholders, not only about the unfunded administrative burden the MOU would place on states, but also about its expanded definition of terms in such a way as to give FDA authority over patient-specific dispensing, long the purview of states and not of the federal government.

“As a result, I suspect we’re likely to see litigation by compounding pharmacies adversely affected by the MOU. We could even see litigation by states,” said Brunner. “FDA could have worked with stakeholders on this and created a workable MOU, but as ever, it kept its own counsel, and here we are.”