Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice in the Washington, DC, office, was quoted in an article titled, “Changes in FDA Processes, Enforcement Will Be Hot Topics in New Year, Experts Say.”
According to some members of the advisory board of BNA’s Medical Devices Law & Industry Report, 2011 could see big changes in the way devices are developed, approved, and paid for, as well as a continued uptick in Food and Drug Administration enforcement actions.
Thompson expressed concern about particular proposed modifications to the 510(k) process. Thompson cited the proposal to clarify when a device no longer should be available for use as a predicate device.
Thompson disagreed that device companies are doing enough to avoid FDA scrutiny. He said, “Of course some medical device companies have” stepped up compliance efforts,” but said he “fear[ed] the vast majority of them have not taken any material steps to really try to reduce the risk.” Thompson noted that “there are pockets of companies that have already been the subject of some enforcement actions that are taking it more seriously.” And, he said, “developing comprehensive and well-reasoned good promotional practices, then training personnel in those practices, remains the best way for companies to manage their compliance risk.”
In 2010, FDA officials threatened to start bringing criminal charges against executives of noncompliant companies and, in fact, filed an indictment against a former drug company in-house counsel. Thompson said this could happen in the device area as well, but doubted it would be soon or on a very large scale.
“FDA made so much noise about this that they would be frankly embarrassed if they did nothing,” he said. Thompson added that he could “see the government making an example out of a couple of people, but not pursuing it on any large scale.” The same was true of exclusions, he said. “The legal authorities are different, and the business practices are different” between the drug and device industries, he said, adding that he “hasn’t seen any movement in that direction.”