The FDA's Quality Revolution

Authors

  • Peter J. Pitts President, Center for Medicine in the Public Interest, former FDA Associate Commissioner

DOI:

https://doi.org/10.5912/jcb718

Keywords:

FDA, Office Pharmaceutical Quality, Bioequivalance, Biosimilars, Inspections, Quality, Safety, Efficacy, Effectiveness

Abstract

Let it be said that the spark that ignited the flame was when FDA leadership asked, “Do we know enough about the quality of drugs that are sold in the United States.â€

In 2009, the FDA announced its Safe Use of Drugs Initiative.  The theory being that one way to make drugs safer is to ensure that they are used as directed. The main strategy was education and the agency’s efforts were (and are) aimed at physicians, nurses, pharmacists, and patients.

Earlier this year, the agency announced not just an office, but a Super Office of Pharmaceutical Quality, further underscoring that the FDA operates not under a two-dimensional system of safety and efficacy, but a three-dimensional approach that includes quality … with a capital (indeed a “superâ€) Q.

Since there is no such thing as a safe substandard product, the agency is putting time, resources, and the use of the bully pulpit to go beyond cGMPs, API and excipient sourcing to develop a risk-based approach that includes data gathered from a variety of sources including manufacturing inspections, adverse event reporting, and substandard pharmaceutical events as evidenced in the agency’s bioequivalence- driven actions with bupropion in 2012, metoprolol in 2014, and methylphenidate in 2015.

So, in many respects, pharmaceutical quality is both a pre and post-licensure endeavor and, like Safe Use, a scientific and educational enterprise that requires close coordination with many stakeholders. And it won’t come easily or inexpensively. As Aristotle said that, “Quality is not an act, it is a habit.â€

Author Biography

  • Peter J. Pitts, President, Center for Medicine in the Public Interest, former FDA Associate Commissioner

    Peter Pitts is President of the Center for Medicine in the Public Interest. A former member of the United States Senior Executive Service, Peter was FDA’s Associate Commissioner for External Relations, serving as senior communications and policy adviser to the Commissioner. He supervised FDA's Office of Public Affairs, Office of the Ombudsman, Office of Special Health Issues, Office of Executive Secretariat, and Advisory Committee Oversight and Management.  He served on the agency’s obesity working group and counterfeit drug taskforce and is a Special Government Employee (SGE) consultant to the FDA’s Risk Communications Advisory Committee.

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Published

2015-10-01

Issue

Vol. 21 No. 4 (2015)

Section

Legal and Regulatory Updates