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Several major life sciences companies removed four product videos from the popular YouTube website after the Boston-based Prescription Project advocacy group complained to the feds these presentations were essentially ads and didn’t contain full disclosures about the products.
The companies in question were Abbott Laboratories, based in Illinois; Medtronic Inc., based in Minnesota; and Stryker Corp., based in Michigan. Late last year, the nonprofit Prescription Project became aware of the videos on YouTube. “At least one of the videos on YouTube was a broadcast ad with the disclaimers left out,” said Allan Coukell, director of policy for the nonprofit. “The other videos appeared to be promotional videos produced by public relations firms for the companies.
They didn’t contain content that conforms to the U.S. Food and Drug Administration’s (FDA) fair balance rules. That includes any disclosures or warnings, and were clearly in violation of FDA’s standards and we asked the agency to tell the companies.”
To be compliant, an ad must have brief statements of the drug or device’s usage directions, and mention potential side effects. “Unbalanced ads overstate the potential benefits without the risk information that would let someone make an informed decision,” he said. He claimed the videos were pulled right around Dec. 3. “Our petitions unquestionably caused the companies to yank the ads,” said Coukell.
Two of the companies said they were committed to adhering to the FDA rules. “Abbott’s practice is to comply with all regulatory requirements and to provide patients and consumers with accurate and complete product information,” stated Jonathon Hamilton, spokesman for Abbott Labs, in an e-mail. He noted that in July 2008, the company had posted Abbott Labs’ Xience V stent videos on YouTube that had links to the product’s risk and safety information. However, to avoid problems in the future, “we will embed safety and risk information in the videos moving forward.”
A Medtronic spokesman said in an e-mail: “The video in question has been removed from the Internet. Any additional video produced by, or on behalf of, Medtronic that does not comply will be addressed immediately.” Stryker stated that because this was “potentially a legal matter,” it wouldn’t comment.
The three companies are seeing how risky the web can be, noted an expert on corporate liability. “One of the downsides of the Internet is the relative ease with which anyone, including a rogue employee, can immediately broadcast material that may not be compliant,” said Steve Schoenberger, vice president at Whitman-based Mason & Mason Technology Insurance Services Inc., which caters to life sciences companies. If a life sciences company willfully posts an ad without the requisite warning data, it can weaken any future legal defense he said. “It’s also possible that they have just voided coverage under a liability policy,” he said.
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