With federal courts casting serious doubt on the Food and Drug Administration's power to control truthful speech about medical products, the agency wants the drug and medical device industries to sound off on what they think the rules should be — and please be specific.
"Give us some examples," said Lauren Silvis, deputy policy director in the FDA's medical device division, said Wednesday on the final day of the AdvaMed 2016 industry conference in Minneapolis. "It is going to be challenging to develop a policy in this area without a robust record."
The FDA has long maintained that it would be illegal for a sales rep to tell a doctor about safe uses — or dangerous misuses — of a medical device or drug that are not listed on the product's FDA-approved label. Several recent federal court cases, including February's exoneration of Maple Grove device executive Howard Root, suggest that the First Amendment gives companies more leeway in sales pitches than the FDA has allowed.
On Nov. 9, the day after Election Day, the FDA will kick off a two-day hearing in Washington at which it will solicit ideas for new ways to regulate what companies can say when selling approved medical products. Online comments can be submitted to the FDA through Jan. 9.
The FDA has a delicate balance to strike, with billions of dollars in profits and legal settlements on the line.
The agency is charged with protecting the public from unsafe devices and drugs, and the government has collected billions in settlements from health care companies accused of promoting so-called "off-label" uses that lack formal safety studies. Yet many devices and drugs are routinely used in unapproved ways, which is legal for doctors to do, and the manufacturers can't legally reveal what they may know about the safety of off-label uses.
"We need to figure out how to get good information to the physicians," said panel moderator Tony Blank, CEO of a company called Infinity Biomedical.
The failed case against Root and several others in recent years have made it clear that at least some federal judges and juries do not believe FDA has the authority to regulate "truthful and non-misleading" speech about off-label uses.
But FDA's Silvis said it's not enough for the industry to just say it wants more latitude in communicating with doctors about medical practices not approved or cleared by the agency. Rather, regulators are looking for specific examples of products or practices where truthful speech about off-label uses would benefit patients and the medical community.
She called next month's meeting and the related public comment period a "good faith effort to get a lot of feedback" on the issue.
Sheldon Bradshaw, a lawyer in Washington who went into private practice after serving as chief counsel to the FDA, told the audience Wednesday that he advises health care companies not to give salespeople carte blanche with truthful off-label promotional claims, even though recent decisions seem to have carved out new leeway without any corresponding regulations.
He noted that the recent decisions on truthful off-label promotion come from nuanced, fact-specific cases.
"People who see these cases and starting thinking, wow, I can say go out and say what we want to say, to whom we want to say it — you may find yourself getting crosswise," he said. "And you may find ... that perhaps your statements aren't true or in fact are misleading."
Joe Carlson • 612-673-4779
