Senate Appropriations Committee “Concerned” That FDA Has Not Consulted With Stakeholders Before Releasing Guidance
As reported by The Hill, earlier this year, the Senate Appropriations Committee told the Food and Drug Administration (FDA) to reach out to stakeholders such as physicians, patients and pharmacists before releasing new guidances for compounding pharmacies. Under the 2013 Compounding Quality Act, the FDA has greater oversight and funding to regulate compounding pharmacies. However, in a new report, the committee is also requiring the agency to meet with stakeholders before issuing further guidances. According to Sen. Lamar Alexander (R-Tenn.), the committee’s ranking member, physicians, patients and pharmacists have told him the agency has not consulted with them to address their concerns before developing a new guidance.
Committee Report
The language included in the committee’s report was: “The Committee notes that the Food and Drug Administration has begun implementing the Compounding Quality Act by releasing guidances and working to appoint members to the Pharmacy Compounding Advisory Committee. The Committee is concerned that the Food and Drug Administration is not meeting with any stakeholders before publicly releasing further guidance for public comment. The Committee directs the Food and Drug Administration to meet with stakeholders to help inform the implementation of the Compounding Quality Act to ensure continued access to safe compounded drugs for which there is a clinical need.”
Unclear if “Listening” Leads to Policy Changes
In July, FDA announced the availability of its final guidance for traditional compounding, Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act, into the Federal Register. Reflecting the agency’s thinking on the compounding part of the Drug Quality and Security Act (the compounding and track-and-trace legislation signed into law late last year), the final guidance closely tracks the draft guidance.
The American Pharmacists Association (APhA) submitted comments on February 3 regarding the draft guidance. APhA’s comments focused on office-use compounding and limits on out-of-state distribution of compounded drug products, including a 5% limit on such drug products and a Memorandum of Understanding (MOU) between FDA and the states.
It appears that pharmacists can expect additional guidance with policy changes on both issues, according to Jillanne Schulte, JD, APhA Director of Regulatory Affairs. However, “Essentially, FDA kept the guidance as it was,” Schulte said. “Based on the listening session with FDA last week, it sounds like they’ll be making policy changes in additional guidance (both for office use and the MOU) that has yet to be released.” (emphasis added)
Industry Outreach to FDA Important to Understand Confusing Regulatory Scheme
David G. Miller, RPh, executive vice president and CEO, International Academy of Compounding Pharmacists (IACP), believes that the new legislation has not really changed compounding practices for traditional compounders, but it has raised some unanswered questions about what practitioners are to do in day-to-day patient care when current state and federal laws appear to conflict or when prescribers do not understand or believe that this law applies to them as well. “Doing the ‘right’ thing for the patient may actually conflict with the law,” he said.
Miller also acknowledges that enactment of the DQSA has helped pharmacy to focus on the importance of compliance and practice standards. He urges pharmacists to pay attention to — and comment on — regulations at both the state and federal levels, so that “the government makes informed decisions that do not affect proper medication management and patient care.”