Government scrutiny in the U.S. is up, as is commonly known, a topic taken up by Daniel Donovan, of the law firm of King & Spalding (Washington), during the Medical Device Manufacturers Association's (MDMA) annual meeting last week.
Donovan said that firms should be alert to anything in their operations that might prompt such scrutiny, because "you can quickly find yourself enmeshed in a congressional investigation."
Transparency "is a mantra for Sen. Grassley and for others ... in the Senate and the House," Donovan said, adding that his former boss "is particularly focused" on the device and pharmaceutical industries, and "the thing that runs throughout [his interest] is transparency."
Donovan reminded the audience that congressional investigations are aided by federal agencies such as the FBI. "They can launch investigations of a company or industry using the Government Accountability Office and the Office of Inspector General" as well, and these committees "can sensationalize things to drive their agendas." He mentioned Henry Waxman (D-California), the chairman of the House Oversight and Government Reform Committee as being "extremely active," among others.
Among "the ... primary players in all this are the media," Donovan said, especially the mainstream media, "who have a very symbiotic relationship with congressional staffers." He said that the relationship is of sufficient seriousness that it is safe to conclude that "[w]hat's driving laws is media attention."
Donovan warned device makers that "your competitors are going in and talking to congressional committees" as well, with complaints about perceived abuses. Associations also influence Congress, as do private-plaintiff attorneys. "Congressional investigators will accept information from all parties," so "if your association is not providing balance" to the denizens of Capitol Hill, it "is not a level playing field."
"You're not doing enough to disclose adverse events," Donovan said of the view from the Hill, but asserted that even "if you've done everything that FDA requires, it may not be enough." This more often "plays out in off-label issues" as well as with clinical trial registries and physician payments.
Donovan went a bit low-key by remarking that firms "need to be very proactive ... and recognize the political environment you're in," and urging MDMA attendees to remain mindful of the fact that "[t]here is nothing more likely to generate a congressional investigation than a failure to report adverse events."
— Mark McCarty, Washington Editor