The Pharmacist's Roles With FDA Advisory Committees
In 2012, over 800 individuals fell ill and 76 died as a result of fungal meningitis that originated from contaminated steroid injections compounded by the New England Compounding Center.
In 2012, over 800 individuals fell ill and 76 died as a result of fungal meningitis that originated from contaminated steroid injections compounded by the New England Compounding Center (NECC). Classified as a compounding pharmacy, the NECC was allowed to compound products accompanied by a legal prescription to meet the special needs of individual patients. A collaborative and extensive investigation by federal, state, and local agencies revealed that the NECC was functioning beyond the capacity of a compounding pharmacy; in fact, the pharmacy had also operated as a drug manufacturer since as early as 2006. In response to this incident, Congress passed the Drug Quality and Security Act in 2013. This law, which amended the Federal Food, Drug, and Cosmetic Act, granted the FDA more authority to regulate and monitor the manufacture of compounded drugs. In subsequent years, the FDA has continuously worked to issue draft and final policy documents to implement this law, collaborating closely with state officials who are responsible for the daily oversight of compounders to better serve and protect the public from another compounding tragedy.
​​​​​​Policy, regulatory, and health care—related decisions such as these are often discussed at FDA Advisory Committee (AC) meetings. Currently, the FDA has 33 standing ACs covering several public health topics, such as human drugs, medical devices, and pediatrics. The ACs consist of experts in the field of the respective topics and can include individuals from various medical, regulatory, scientific, and legal backgrounds, as well as a consumer, industry, and patient representative.
The committees help to support the FDA’s mission to protect public health while abiding by the requirements within the Federal Advisory Committee Act (FACA). FACA established a process to ensure that the advice received by these experts was objective and accessible to the public. Within the FDA, the responsibility for the preparation and organization of the Center for Drug Evaluation and Research’s AC meetings lies primarily with the Division of Advisory Committee and Consultant Management (DACCM) within the Office of Executive Programs.
A pharmacist with DACCM can serve as a public health analyst (PHA). The role of a PHA is to ensure the credibility and integrity of the AC meeting process by analyzing member-reported interests for conflicts of interest under 18 US Code §208 or appearance issues under 5 Code of Federal Regulations 2635.502 with regard to the product at issue and topic coming before the AC meeting, as well as competing products. PHAs must have a full understanding of the federal laws, regulations, and policies governing ethics to make this determination and to be able to analyze a range of financial and nonfinancial interests for each committee member and temporary voting member.
A conflict of interest (COI) may be in the form of a direct financial interest with the sponsor, competing companies, products, or topics coming before the committee, through salary, stock ownership, or research agreements. The challenge with the COI analysis process is that many companies are often affiliated through special licensing or research agreements. In addition, the committee member is often unaware of the various agreements, so it is incumbent on the PHA to properly research the products at issue, the competing products, and the companies involved and ensure that the committee members have no relevant interests that could rise to the level of a COI or the appearance of a conflict. Another challenge is that the AC meetings require experts from various disciplines. To be an expert, an individual usually has been involved in a variety of studies, many of which are often sponsored by pharmaceutical companies. Additionally, many experts would have worked extensively with products related to their field of expertise, thereby increasing the likelihood of a COI or an appearance issue.
Pharmacists make ideal PHAs because of their attention to detail, knowledge of medications, knowledge of various disease states, critical-thinking skills, and ability to analyze data. The position also requires strong writing skills and the ability to meet short deadlines. The PHA role is a critical aspect of the FDA AC meeting process because recommendations from the AC meetings have national and sometimes global impact, as the FDA uses these recommendations to make decisions and take regulatory actions. With that in mind, the PHA role can be very rewarding, enabling the pharmacist in position to ensure the credibility and integrity of subsequent FDA decisions in protecting public health.
LCDR Nga Doan, PharmD, is an officer with the US Public Health Service and a senior public health analyst with the FDA’s Division of Advisory Committee and Consultant Management.