AAFP Calls for FDA Discretion in Compounding Guidance

Academy Joins Letter Urging Agency to Avoid Regulatory Overreach

August 21, 2019 12:09 pm News Staff – Passage of the Drug Quality and Security Act in the wake of a 2012 outbreak of fungal meningitis was a hard-earned victory for public health. But now a policy trickle-down the FDA is considering could unduly restrict family physicians and limit their ability to deliver vital care to their patients.

That's the message of an Aug. 13 letter to the FDA(3 page PDF) signed by the Academy and 20 other medical organizations as the agency considers updated oversight of compounding drug products. It was sent to Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. Other signers included the AMA and the American Osteopathic Association.

"We remain concerned about the possibility that actions taken by the FDA in finalizing compounding-related guidance documents may significantly hinder our physicians' ability to provide critical treatments to patients in office settings," said the letter, which followed up on a recent FDA listening session on the topic.

At that meeting, according to the letter, FDA officials expressed interest in finalizing the guidance in a manner that could potentially restrict physicians' ability to prepare sterile drug products to administer to patients in their offices.

Such a move would jeopardize patient well-being, warned the Academy and its co-signers.

Hindering physicians' ability to prepare critical sterile treatments for their patients in an office setting, said the letter, could be expected to significantly reduce access to care and overall health outcomes even as it raises costs.

"Reducing access to necessary treatments also presents increased risk to the health status of patients nationwide," it added.

The FDA's proposed "Insanitary Conditions at Compounding Facilities" guidance, released as an updated draft document in September 2018, reflects one of the FDA's policy goals: revision of the agency's compounding oversight program.

At its most stringent, the guidance would require physicians' offices to meet the same sanitation standards as compounding pharmacies -- a burden to which the letter objected.

"Physicians are simply unable to retrofit practice facilities with new equipment/clean rooms or undergo other structural facility changes to meet safety and sterile requirements akin to those in compounding pharmacy facilities," the letter said. "In addition, … there is a significant lack of evidence showing risks to patients that warrants further change or restrictions on practice."

In fact, most publicly available reports of outpatient infections tracked by the CDC for which the root cause of infection could be determined appeared to implicate unsafe injection practices rather than the compounding of sterile drug products.

Turning to outside compounding pharmacies for ready-to-use versions of medications that are typically prepared in the office is usually not a viable option, according to the letter, because of barriers related to issues that include drug stability and administration delays.

"Patients of many specialists rely on the ability of their physicians to prepare these drugs in-office to avoid certain increased risks, avoid followup appointments for treatment and to avoid receiving treatment in higher-cost care settings," the letter said.