FDA Holds Public Meeting in Effort to Better Regulate Pharmaceutical Compounding

by Holland & Knight LLP

On December 19, 2012, the U.S. Food and Drug Administration (FDA) held a public meeting, broadcast live on the Internet, to discuss the respective roles of the federal and state governments in regulating pharmacy compounding. This public meeting came on the heels of FDA Commissioner Dr. Margaret Hamburg's mid-November testimony before the House and Senate, which was scheduled after the nationwide fungal meningitis outbreak triggered by the New England Compounding Center, which was first reported in October 2012.

Commissioner Hamburg opened the meeting by noting that the gathering was a "critical and essential step in deepening the understanding of issues raised by compounding pharmacies." Representatives from all 50 states and the District of Columbia took part in an all-day conference with the FDA prior to the public meeting. The commissioner stated that she thought that everyone had benefitted from the day's discussions, and she observed that the strong turnout for the meeting speaks to the "gravity and urgency" of the concerns relating to compounding. She acknowledged the "magnitude of the devastation" brought about by the issues related to the New England Compounding Center, as well as the "amazing work" that the states did in responding to the fungal meningitis outbreak caused by processing problems at this particular compounding pharmacy. Dr. Hamburg noted, "The need to be proactive on compounding underlies why we so wanted to undertake this 50 state meeting today." She acknowledged that the states play a fundamental role in the oversight and licensing of traditional compounding.

Dr. Hamburg stated, however, that some pharmacies have moved beyond traditional compounding. She suggested pharmacies that ship beyond state lines or compound sterile medications may pose a threat to public health and listed a number of examples of FDA reports of patient harm stemming from compounded products.

Compounded drugs are exempt from various provisions of federal law, including premarket approval, and compliance with good manufacturing practices. Current law does not absolutely limit production volume, nor does it prohibit anticipatory compounding. Dr. Hamburg said, "I believe it's time to end the ambiguity and to close those gaps." She said that there is a need for a "risk-based" regulatory system.

FDA Invites Public Comment

The FDA has invited public comment on these issues. Comments are due by January 18, 2013. Dr. Hamburg stated that the FDA is "eager for input from any and all who want to share their perspectives, experiences, and ideas on this critical issue of pharmacy compounding." She noted that "compounding pharmacies have presented particular challenges, but we can and must address them," and that "this is a shared responsibility" with the states.

The December 19 meeting focused on four discussion topics. Heidi C. Marchand, assistant commissioner of Special Health Issues, moderated the discussion and state representatives were given the opportunity to provide input. The following is an overview of the four topics that were discussed:

1. Scope of Authority and Resources for the States

The first discussion topic focused on whether states currently have adequate authority and resources to provide oversight of pharmacy compounding sufficient to protect consumers. John Kirtley, the executive director of the Arkansas State Board of Pharmacy, spoke about the need to define the terminology and "jargon" used to describe compounding. He expressed concern about anticipatory compounding and medications that cross state lines. He also talked about compounding that happens in prescriber offices and hospitals and noted that Arkansas requires sterility, potency and other testing for certain batch sizes.  

Jay Campbell, the executive director for the North Carolina Board of Pharmacy, spoke for the Southeast Region and also expressed concern about what goes on in other states. He suggested that there perhaps should be a standardized level of training required for pharmacy investigators and inspectors in all states. Campbell also indicated that states need to work on better communication regarding problem pharmacies. For pharmacists, there are already good information-sharing databases administered by the National Association of State Boards of Pharmacies that can detect red flags. A similar system for pharmacies is in development.

2. The Need for Clear Definitions

Cody Wiberg, the executive director of the Minnesota Board of Pharmacy, spoke for the Central Region. He pointed out that there are "really a number of sub-issues that are interlocked." He questioned the definition of "pharmacy compounding." Wiberg discussed whether standardized definitions are needed. He observed that some states do not always have the resources they need to oversee pharmacies. Some states only conduct complaint investigations, for example, or their inspectors may not always be pharmacists. In some states, pharmacies, manufacturers and wholesalers are regulated by different agencies. Almost all states, but not every state, licenses out-of-state pharmacies. He said, "Up until now, we've pretty much depended on the other states to regulate [pharmacies in other states]. That is a potential issue." If one state does not have adequate resources, it can affect every state that licenses their facilities. Wiberg noted that just about every pharmacy in Minnesota does some degree of "traditional compounding." Fewer states may have the resources to regulate facilities like the New England Compounding Center.

Bernadette Dunham, director, Center for Veterinary Medicine, Office of Foods and Veterinary Medicine, noted that, many times, pharmacists are compounding both for animals and humans. She asked whether states differ in regulation of compounding activities depending on whether it is for an animal or a human. The panel participants confirmed that in Arkansas, North Carolina and Minnesota the standards are the same — regardless of whether the drugs are for animals or humans.

Attendees also discussed what the federal government's role should be in regulating "higher risk" pharmacy compounding. Pharmacies that compound "high volumes of drugs for interstate distribution" were characterized as high risk. One speaker emphasized the need to define "high risk" and "low risk," as well as the need for "bi-directional" communication between the states and the FDA. If there is an untoward finding, the states, particularly the ones where the problematic pharmacies are located, need to hear about it as soon as possible. The public, as well as the profession, is confused about how a manufacturer is defined. One speaker advocated for a federal definition of manufacturing that can withstand judicial scrutiny. Distribution across state lines is clearly manufacturing, but dispensing across state lines may not be.

3. Rebalancing Federal and State Regulation

The third discussion topic centered on whether there is a way to "rebalance" federal and state regulation of compounding in a way that would better protect the public health. State regulators suggested that there could be improvement in FDA outreach to everyone. There was also a suggestion for state regional meetings where the FDA could provide feedback. One speaker suggested that state and FDA websites need to be improved so information can be searched and located more easily. Another speaker noted that FDA warning letters need to be shared with the National Association of Boards of Pharmacy and the state board of pharmacy where the problematic facility is located. The speaker noted "that communication to state regulators has been sporadic at best."

4. Role of the States in Enforcing New Federal Standards

The fourth discussion topic focused on whether panelists see a role for the states in enforcing a federal standard for "non-traditional" compounding. Conference participants noted that resources differ from state to state in terms of manpower. One speaker observed that the Centers for Medicare and Medicaid Services (CMS) funds surveyors in each state to do inspections on behalf of CMS for Medicare providers, and perhaps that model would work for the states. The FDA could contract with a willing state to perform inspections for the federal level. Also, states could incorporate by reference the federal law.

Dr. Hamburg closed the meeting by thanking the participants. She stated, "I think we will be able to put in place some new systems and partnerships that will be really, really important and make an enduring difference."

FDA Focusing on Clarity and Traditional v. Non-Traditional Compounding

The federal activity around pharmacy compounding during the past three months, including this recently FDA-orchestrated public meeting, gives all stakeholders plenty of issues to consider. There appears to be consensus that clarity is needed to sharpen the distinction between compounding pharmacies and drug manufacturers. It is less clear whether the needed clarity can be accomplished through FDA regulation or guidance, or whether an act of Congress is needed. Commissioner Hamburg is looking for help from Capitol Hill, offering draft legislation that would define and distinguish drug compounding into two categories: traditional versus non-traditional.

At first blush, this approach may seem practical, reflecting much of what currently goes on in the marketplace. But there are FDA-watchers, including the very visible Public Citizen, who have expressed concern that codifying "non-traditional" compounding will legalize the very conduct in which NECC was engaged that led to the fungal meningitis outbreak. It has been suggested that if Congress were to legislate a "non-traditional" compounding standard, it would, in effect, create a substandard drug manufacturing standard.

Other issues stakeholders should consider in framing comments to the FDA include:

  • inconsistency of enforcement and common standards among state boards of pharmacies
  • lack of standardized communications among state boards of pharmacy
  • limited resources at the federal and state levels to regulate the estimated 7,500 pharmacies engaged in compounding that likely goes beyond traditional compounding (compare this to the approximate 5,600 drug manufacturers and facilities the FDA now regulates)
  • coordination required between the FDA and state boards of pharmacy and the circumstances under which each agency has primary and secondary jurisdiction

Certainly there are plenty of challenging issues for interested parties to consider before submitting comments by the January 18 deadline to www.regulations.gov, Docket No. FDA-2012-N-1154. Holland & Knight's experienced lawyers are available to assist you in preparing and submitting comments. 

To ensure compliance with Treasury Regulations (31 CFR Part 10, §10.35), we inform you that any tax advice contained in this correspondence was not intended or written by us to be used, and cannot be used by you or anyone else, for the purpose of avoiding penalties imposed by the Internal Revenue Code.

Written by:

Holland & Knight LLP

Holland & Knight LLP on:

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