Several years ago, when Gert Bos was a Notified Body auditor, he was auditing a company that made degradable, injectable facial fillers that were regulated as medical devices when it dawned on him that something didn’t seem quite right.
“The company’s product was very successful commercially … and as a reviewer and auditor, I had always been surprised by how effective the company was in selling a medical product for use on patients with HIV or other types of degenerative diseases,” said Bos, currently a Regulatory Affairs Professionals Society (RAPS) board member and a partner with Qserve Group.
“So, during the audit I asked to see their marketing materials,” he said. At first, company officials gave Bos a brochure to read, but he pressed on and asked for more. “They ultimately brought me to a video screen and they showed me the videos they had in their native language that would run on television. It was all about the benefits of undergoing cosmetic [procedures]. They basically were falsifying their claims.”
It was medical product marketing run amok.
It’s because of situations like the one Bos described that it’s imperative for professionals in regulatory or quality roles to be in consistent touch with their marketing department so false claims about devices or drugs aren’t made, either purposely or accidentally.
Jocelyn Jennings, VP of Regulatory Affairs and Quality Assurance for Mycovia Pharmaceuticals, says when questions arise around product claims and marketing materials, she refers to her company’s standard operating procedures, or SOPs.
“I see what the SOPs say and I take it from there. Our SOPs have examples of language that should not be in any of our ad promos,” she said.
“If it’s a ‘no,’ then it’s a ‘no.’ The marketing person can either get on board with that or not. But the bottom line is, it’s medical, legal, and regulatory that has the final say.” – Jocelyn Jennings
Mycovia’s marketing pieces also “go through a medical and legal review, along with a regulatory review. If the material doesn’t pass the sniff test from a medical, legal, or regulatory standpoint, then it’s given a ‘no,’ because what you don’t ever want is to have an untitled letter from the FDA [US Food and Drug Administration] or the agency’s OPDP [Office of Prescription Drug Promotion] telling you to take your advertising down and correct it within 15 days,” said Jennings, who is also a RAPS board member.
She pointed out that 15 days isn’t much time to make corrections to marketing materials, especially if it’s a large campaign built around a marquee drug or device.
“This is why I’m always talking with our marketing team,” Jennings said. “If I do give them a ‘no,’ I always try to offer them alternative language they could use in their ads. Because at the end of the day, it’s about patient safety and it’s about protecting the company. So, I look at marketing materials from those perspectives, and if it’s a ‘no,’ then it’s a ‘no.’ The marketing person can either get on board with that or not. But the bottom line is, it’s medical, legal, and regulatory that has the final say.”
The FDA has been taking notice of problematic marketing of late, particularly in the pharma industry. The agency’s commissioner, Marty Makary, sent thousands of letters to drug companies on Sept. 9 directing them to stop “noncompliant advertising” and “bring all promotional communications into compliance.” The letter claims the FDA, “for far too long,” has “permitted misleading direct-to-consumer (DTC) prescription drug advertising.”
“DTC advertising can distort the patient-clinician relationship and create increased demand for medications regardless of clinical appropriateness,” Makary wrote in his letter to makers of pharmaceuticals, noting that the agency “is concerned patients are not seeing a fair balance of the information regarding a drug product. …The stakes surrounding prescription drug ads are extremely high.”
RA/QA ‘Friendship’ With Marketing Encouraged
Mindy McCann, also a RAPS board member and a Qserve Group VP, is a firm believer in regulatory and quality “being friends” with their company’s marketing team to ensure that important – and sometimes uncomfortable – discussions flow freely.
“When it’s patient safety on the line, you must use your moral compass and say, ‘Look, this is misrepresentation. Not only is it not going to be safe for the patient – and we always think about the patient first – but it’s also not safe for the business. When a product is misrepresented, the consequences to you and to us as an organization are tremendous,’” McCann said.
When it comes to product claims and marketing, “there is a clear line. And although it may be hard to say ‘no,’ I believe that if you can explain what the issues are and what the repercussions are, people are generally going to be on board with you and they’re going to understand,” she said. “You can say, ‘This ad is a misrepresentation, and this is something terrible that can happen to a patient if we imply these things.’ Most people will listen if you justify why you’re saying ‘no.’”
Marketing materials that overstate data and other information are also something that regulatory and quality experts need to keep an eye on.
“I’ve always had a very firm policy for marketing: If you’re going to cite it, then have a clear source,” McCann said. “I’ve also asked marketing to get rid of fluffy descriptive words because they always tend to be misleading. And if there was ever a caveat that a product’s clearance or approval was only based on a study of, say, three people, I would make sure that information was placed in a footnote in materials.
“Just make sure everything is disclosed properly so that there’s a balance,” she added. “That was my approach to managing those kinds of things, where I felt like, ‘OK, this marketing is now at a point where I’m comfortable because there’s full disclosure associated with it.”
Comments from McCann, Jennings, and Bos came during RAPS Convergence 2025 in Pittsburgh.