Special agent explains FDA history, myths

11/15/2013 12:07:35 PM
Special agent explains FDA history, myths
[Legal Monitor Worldwide]

Published Date: November 15, 2013 12:05:30 PM EST

Michael Widenhouse, assistant special agent in charge of the Washington metro area for the Food and Drug Administration's Office of Criminal Investigations, spoke Nov. 11 to Earle Mack School of Law students about his career and health law in a lecture hosted by the Health Law Society.
Widenhouse began his law enforcement career in the Baltimore Police Department and went on to join the Army Criminal Investigative Command, where he served in Bosnia before joining the FDA. Widenhouse explained that most of the criminals he pursues operate internationally.
"The vast majority of our cases now have international ties," Widenhouse said. "Most of the bad guys that we are dealing with are offshore. We do have some domestically, but the ones who are bringing in the really dangerous products, smuggling and everything, our targets are offshore."
The OCI has many operatives working with international organizations such as Interpol and Europol.
Widenhouse also recalled the history of the organization and changes in the FDA's jurisdiction. The FDA was founded in 1906, and during the first half of the 20th century it slowly expanded to cover foods, drugs, medical devices and cosmetics.
Though the FDA has many departments, called centers, OCI falls within the Office of Regulatory Affairs.
"Within FDA you have the six centers, but then you have the Office of Regulatory Affairs; that's where we fall under. The Office of Regulatory Affairs is what most people think of when it comes to the FDA; it's the eyes and ears on the ground. These are the people that are out inspecting, they are checking manufacturers, they are checking retail establishments, and they are the ones that are doing the liaisons with the state health departments and with the state regulatory agencies. They collect samples that are sent in for analysis," Widenhouse said
He dispelled the myth that the ORA is one giant lab that tests products. He explained, "One of the misconceptions is that the FDA is sort of like an underwriters laboratory, that — say Pfizer comes out with a new drug, that they send it to FDA and we test it. That doesn't happen. There is no lab testing new drug products when they are brought out to the FDA. These new drugs, the manufacturer, the drug company does all their own research, all their own clinical trials, and they run all the stuff up. And it comes in to that center for drugs, and when it goes in there you have a cubical farm of people that are reviewing someone else's testing data. So most people think that these drugs are coming in to FDA and we are testing them; we're not."
Ariella Cohen — a second-year law student and president of the Health Law Society, which hosted Widenhouse — explained that the society has had six such events this term and hopes to have 15 more next semester. According to Cohen, the Health Law Society hosts such events to help educate and prepare students for the pro bono work that is required as part of the law school's curriculum. The Health Law Society managed to connect with Widenhouse through one of Cohen's professors, who had had a previous professional relationship with him.
Viren Doshi, a second-year student in the juris doctor and master of public health dual program, said the night was a success.
"In terms of content, it was exactly what we wanted. It was very, very informative," Doshi said. "It was multidisciplinary, so you get the criminal law side of it and you get the health law side of it."

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