Three months ago, Ralph Tyler left his job as chief counsel at the FDA, reportedly for personal health reasons, among other things. This week, he has apparently recovered - or at least he feels well enough to undergo the stress of returning to work and slaving over documents. How so? He has taken a job with the Venable law firm which, it so happens, has a large practice devoted to helping drug and device makers (see here).

His departure from the agency came after just 18 months on the job, although it was not entirely unexpected. Before joining the FDA, Tyler was the Maryland Insurance Commissioner, the same state where former FDA deputy commish Josh Sharfstein worked as Baltimore health commissioner. The connection suggested Tyler was hired due to his ties to Sharfstein, who left earlier this year (read this).

His tenure was reportedly marked by complaints that the FDA was guilty of “regulatory overreach and conflicts with both statutes and congressional intent,” at least according to FDA Week, which also wrote there was “substantial criticism” from drug and device makers that believe the agency “often ran afoul of the law.”

One example cited is concerned that the US Department of Health & Human Services and the FDA want to use the so-called Park Doctrine to punish miscreants. This would allow misdemeanor charges to be filed against execs for actions committed by their companies, even if the exec did not know about illegal activity. The goal is to exclude execs from participating in federal healthcare programs.

The issue is being raised by three former Purdue execs, who are fighting a court ruling that upheld a decision by the US Department of Health & Human Services to bar them from working for any company that does business with Medicare, Medicaid and other federal healthcare programs for 12 years. Four years ago, they pleaded guilty to a criminal misdemeanor in connection with the misbranding of the OxyContin painkiller. They maintain, however, they were innocent third parties, because there was no personal wrongdoing (see this).

Of course, Tyler was hired at the FDA to be the agency advocate, which is to say that he was doing his job, which will involve testing the extent to which laws and regulations are appropriate. And increasingly, excluding execs from healthcare programs, is seen as a way of reigning in some of the illegal promotional practices that have characterized marketing for more than a decade. It is not surprising that FDA brass, including Tyler, would generate muttering and worse. Now, though, Tyler will have a chance to see what is was like to view the agency from the other side. Whether he will remain in good health remains to be seen.

[UPDATE: We should note that we reached out to Tyler to ask if he signed any recusal documents, and at 2 pm ET, he sent us this statement: “I will be recused as appropriate and in accordance with applicable ethics rules.”]