Scholarship is one of three components of the Fellowship Program’s academic requirements over the fellows’ 1 or 2-year programs. Our faculty and industry preceptors, as well as our two MCPHS University Faculty Coordinators, encourage and assist our fellows in completing their scholarship requirements throughout their time with us. Recently, one of our second year fellows, Zack McCormack, had his article “United States Food and Drug Administration Advisory Committee Outcomes and Agency Approval Analysis from 2010-2015,” published in the Journal of the American Pharmacists Association. Zack has provided us with a short intro to his article and its cover page as a summary. If you would like to access and download the full article, it will be available for free until 10/23 using the Share Link provided at the end of this blog post.


Advisory committee (AC) meetings hosted by the United States Food and Drug Administration (FDA) are part of the pre-market approval process for many pharmaceuticals in which the opinion of external experts is solicited to help address areas of uncertainty. AC meetings are of substantial importance to sponsors as they come after significant time and financial investment and can have a large influence in a drug’s ultimate approval. Given such implications, this analysis sought to quantify voting behavior and other characteristics of AC meetings and compare that with the FDA’s approval decisions in the years of 2010 – 2015. Among other insights, this assessment showed the FDA’s ultimate approval decision was in line with the AC vote in the vast majority of cases (90%). When it wasn’t, available information indicated this was usually due to the FDA having a differing opinion on presented material’s clinical importance, furthering the notion that AC insight is heavily considered but not the final determinant in agency action.

UNITED STATES FOOD AND DRUG ADMINISTRATION ADVISORY COMMITTEE OUTCOMES AND AGENCY APPROVAL ANALYSIS FROM 2010 – 2015

Objectives

This analysis sought to quantify voting behavior and other characteristics of advisory committee (AC) meetings and compare that with the United States Food and Drug Administration’s (FDA) approval decisions from 2010 – 2015.

Methods

The analysis of the Center for Drug Evaluation and Research AC meetings was conducted utilizing publicly available information from the FDA’s website, drugs@fda, and the sponsors’ websites.

Results

There were 163 voting sessions, 207 votes, and 229 meetings. Voting questions assessed approval (63 percent), acceptable risk-benefit profile (19 percent), efficacy (8 percent), safety and efficacy (7 percent), and safety (3 percent). The AC voted in favor of approval 67 percent of the time and against approval 33 percent, though heavily favored one outcome when voting favorably or unfavorably. The FDA’s approval decision supported the committee’s decision 90 percent of cases. When such agreement didn’t occur, this was due to differences in clinical opinion (43 percent), manufacturing deficiencies (14 percent), lack of manufacturing data (14 percent), and a post-AC event (5 percent). There wasn’t enough information to determine why there was a differing opinion in 24 percent of cases. In instances in which the FDA had a differing opinion, the agency typically didn’t approve a substance in which the committee recommended approval (81 percent).

Conclusion

The results support past research examining the topic from 2001 – 2010. Voting patterns were relatively constant and generally heavily favored one outcome. The FDA’s ultimate approval decision was in line with the AC vote the vast majority of cases. When it wasn’t, this was usually due to the FDA having a differing opinion on material’s clinical importance, furthering the notion that AC insight is heavily considered but not the final determinant in agency action. This topic has importance in understanding pharmaceutical approval in the US, which has clinical practice implications.

Conflicts of Interest and Financial Disclosures

None

Previous Presentation

Presented previously at the American Society of Health-System Pharmacists Midyear Meeting, Las Vegas, Nevada, December 5, 2017

Keywords

Pharmacy; Regulatory; Pharmaceuticals; Administration; Approval

Abbreviations

Advisory committee (AC); Center for Drug Evaluation and Research (CDER); United States Food and Drug Administration (FDA)


headshot of Zack McCormackZack McCormack, PharmD, is a Global Commercial Strategy Post-Doctoral Fellow with MCPHS University and Sanofi Genzyme

To access the full version of this article, please use Zack’s Share Link

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