Ron Johnson, former Director of the Office of Compliance within the Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA), has taken a job as President of BECKER CONSULTING, according to a press release on Market Watch.
According to the release, Mr. Johnson spent 30 years at FDA in the compliance and enforcement areas spending 14-years in managing “complex consulting endeavors in FDA-regulated industries,” says the release.
From the Press Release:
“ Dr. Ron Ginor, President and CEO of BECKER CONSULTING, added, "Ron Johnson's extensive experience at FDA, and his ability to leverage agency knowledge as an independent consultant to the pharmaceutical, biologics, and medical device industries will be an incredible asset to our team, and therefore to our clients. We are privileged to include Ron Johnson as President of BECKER CONSULTING."
Becker & Associates Consulting was established in 2002 and specializes in guiding corporations “through the clinical and regulatory process” for FDA-regulated products.
There is a ban on representing an outside entity to the agency, specifically anything you worked on while with FDA under post employment restrictions “with the intent to influence, on a particular matter regarding specific parties* in which they were personally and substantially involved**. This is a lifetime prohibition.” It’s also a criminal statute under the Office of Government Ethics, 18 usc 207- Post Employment Restrictions (here).
* The term "particular matter involving specific parties" encompasses only matters that involve deliberation, decision, or action that is focused upon the interests of specific persons, or a discrete and identifiable class of persons. The phrase includes investigations, applications, controversies, claims, charges, arrests, or judicial or other proceedings. The phrase does not include general rulemaking, legislation, or policy issues that are directed to the interests of a large and diverse group of persons.
** The phrase "personally and substantially involved" means direct participation as a Government employee through decision, approval, disapproval, recommendation, the rendering of advice, investigation, or other direct participation in a matter. It includes the direct and active supervision of the participation of a subordinate in a matter. Substantiality is based not only on the effort devoted to a matter, but also on the importance of the effort. A crucial step in a matter may not involve a lot of time, but it may be substantial in terms of impact.