21st Century Cures up against FDA's 20th century communication
Posted on June 3, 2015 14:56 pm CDT
When it comes to communication, the 21st Century Cures Act is stuck in the 20th century.
The sweeping biomedical innovation bill aims to speed up development of medical treatments by taking advantage of the latest in science and technology. But provisions meant to update the FDA’s regulations on drug advertising were dropped.
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The agency’s current marketing and promotion regs don’t even mention the Internet. They focus instead on brochures, file cards and, inexplicably, lantern slides — a mid-1800s invention that was supplanted decades ago.
In the era of Facebook, Twitter and YouTube, drug and medical device makers contend a social media reboot is critical.
The first draft of the House Energy and Commerce’s bill did make an attempt. Among other changes, it would have forced the FDA to let drug companies communicate truthful “introductory” information in character-limited settings such as Twitter so long as they hyperlinked to a webpage with more safety and efficacy information.
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That “one-click” concept is gone from the legislation that cleared the committee in late May and is now headed to the House floor. Also gone is a measure directing FDA to revise all regulations and guidances that could apply to online communications so that drug and medical device makers can use the Internet “in a meaningful way” to disseminate truthful and non-misleading information.
In Rep. Billy Long’s view, these provisions would push FDA “to update its regulatory approach to communications to keep up with today’s technology.” The Missouri Republican quickly introduced them as a separate bill after they were cut from Cures, and an E&C staffer signaled that despite the lack of clear bipartisan consensus last month, members remained supportive and that more work on social media could still take place.
The Senate Health Education Labor and Pensions committee could also revive the communication modernization proposals. It’s looking into the same issues as part of a parallel biomedical reform effort, albeit one that’s progressing at a much slower pace.
The social media debate involving FDA, the pharmaceutical industry and Congress is taking place in what is quickly becoming a free speech powder keg. Companies are pushing the agency to align its policies with recent court decisions that have upheld their right to communicate certain information regardless of whether it appears on an FDA-approved product label – the regulatory standard for what is widely marketable.
Without faster change, the industry warns, FDA instead risks a complete overhaul of its advertising and promotional regulations by the courts.
Richard Samp, chief counsel at the nonprofit Washington Legal Foundation, which defends the free enterprise system as its mission, has worked for decades on these issues. Though he doesn’t foresee the courts taking over FDA’s authority to set limits on pharmaceutical marketing, he does expect continued legal challenges that could complicate the regulatory environment.
“FDA has been on a pretty long losing streak when it comes to First Amendment issues, and the longer FDA continues to do nothing, the longer it will be that they continue to have these losses and the more confusion that will be created,” he said.
The agency should see the Internet as unique from older, static forms of communication, drug makers argue.
“Right now, FDA essentially treats a web page or even a banner ad or a tweet as if it were a print vehicle, when patients and health care professionals who are online treat the Internet differently,” said Jeff Francer, VP and senior counsel at the Pharmaceutical Research and Manufacturers of America.
Unlike a print ad, the web allows a company to constantly update information. It also lets consumers quickly jump from one page to additional product details or third-party content, and companies want to know how much they’re on the hook if a third-party site later adds information about a drug’s unapproved use.
Social media triggers other scenarios. Companies say they need more guidance on when they must report adverse drug experiences patients share with them through a posting on their Facebook page, for example.
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At the same time, FDA is itself engaging online — in ways that only accentuate the gap between its lack of guidance for industry, critics say.
While the agency uses Facebook and Twitter to make short announcements on medical products, companies that do the same risk legal repercussions for not including enough risk and efficacy specifics in their post. Even retweeting the FDA’s own communication would be in violation of the agency’s advertising policies.
Rep. Billy Long says that "these provisions would push FDA 'to update its regulatory approach to communications to keep up with today’s technology.'” | AP Photo
“The FDA uses Twitter to link its announcements to more comprehensive information. It is commonsense for the federal government to allow drug manufacturers to use these platforms in a similar fashion,” Long told POLITICO.
FDA first held a public meeting to discuss promotion of agency-regulated products on the Internet nearly two decades ago. Joy Liu, who specializes in drug advertising and promotion at the Washington law firm Ropes & Gray, remembers officials discussing the use of chat rooms and news groups, “sort of a precursor” to social media, she said.
But that 1996 meeting failed to translate into substantial policy changes. And while the agency broached the issue again in 2009, not until last year did it release a pair of Internet-specific draft guidances.
“Is this as important as curing cancer? Maybe not, but it is I think important,” Liu said. “Getting information out about your products, understanding what are the rules of the road, have become critical to companies because they have been prosecuted for allegedly doing the wrong thing.”
Others maintain that FDA has given industry sufficient direction. The agency’s former associate commissioner for external relations, Peter Pitts, says its current guidance on the Internet and social media is fairly good — but that industry has chosen not to pay attention.
“I think it’s a bit of an excuse for industry not to engage,” he said, adding that companies may find it “very frightening” to take part in such immediate, two-way communication with consumers and do the 24/7 monitoring that social media can require. “It takes guts and chutzupah” to engage online, Pitts said.
FDA did not respond directly to a question about its pace in adapting advertising regulations to evolving technology, instead highlighting its two recent guidances and the projected release of further regulations this year.
“FDA sees social media as an important resource for industry and is committed to developing additional guidance for drug and device manufacturers that outline the agency’s current thinking,” a spokesperson said. “We do all of this work with the best interest of patients in mind.”
Yet even as the 2014 draft documents make their way forward, the technology continues to evolve and trigger new questions, said Mark Senak, a lawyer who focuses on pharmaceutical and device marketing at the communications firm Fleishman Hilliard.
For instance, given that many people use a cell phone as their primary means for accessing the Internet, do companies have to make sure any website advertising is optimized for a mobile device? Senak says it is unclear whether a site that’s fully compliant with FDA regulations when it appears on a larger computer screen could face enforcement because of how mandated information displays differently, and perhaps far less accessibly, on a small device.
The agency’s approach is itself a hurdle, according to Senak: Officials always want to fully research an issue in a scientific manner before creating policy. “The whole process of them issuing a guidance document is just too slow for this environment,” he said.
There’s little chance that the U.S. public will stop using the Internet as a go-to resource on health concerns. According to a 2012 Pew survey, 72 percent of Internet users said they had looked online for health information within the past year. Much of that info is unregulated, a reality that also frustrates drug manufacturers.
Aaron Kesselheim, an associate professor of medicine at Harvard University, says FDA’s slow approach to releasing Internet and social media policy may be due to industry’s response to its past guidances on drug and device promotion.
After the agency issued guidance on print media in the 1980s, “investment in print media advertisement exploded,” Kesselheim said. The same thing happened after FDA put out guidance on broadcast media in the late 1990s, revising the parameters on the risk information companies had to include in TV ads. In just two years, direct-to-consumer advertising went from $579 million to $1.3 billion.
“You can understand why the FDA may be wanting to cover all of the bases…and is being deliberative about this,” Kesselheim said. “When these kinds of guidance do come out, they lead to a substantial expansion of advertising — which can have bad outcomes for patients because some drug companies take advantage of it.”