Guts & Chutzpah ... in short supply?

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  • 06/01/2015

From the pages of Politico

21st Century Cures up against FDA’s 20th century communication

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.

The agency’s current marketing and promotion regulations 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.

That “one-click” concept is gone from the legislation that cleared the committee on May 21 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 late Friday that members remain supportive and that more work could take place later this year on proposals that didn’t garner a bipartisan consensus before the committee’s vote.

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, vice president 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.

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.

“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. In 2009, Liu said, the agency reconvened another public meeting, asking how drug makers could fairly balance benefit and risk information for consumers, how they could embed hyperlinks and how they should correct inaccurate information on the Internet about a product.

Not until last year, however, in response to the FDA Safety and Innovation Act of 2012, did the agency 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 the 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 chutzpah” 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.”

The 21st Century Cures bill does expand what industry can say about its products when communicating with health insurers and asks for FDA to issue specific guidance on communication related to a drug’s off-label use.

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 FleishmanHillard.

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 FDA enforcement because of how mandated information displays differently, and perhaps far less accessibly, on a small device.

One of FDA’s hurdles is that “they are an organization that’s really into understanding data,” Senak said. FDA wants 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.”

FDA’s drug center director, Janet Woodcock, testified at an April 30 congressional hearing on the 21st Century Cures legislation that the difference between FDA’s social media use and what industry is permitted to do stems from the different stakes each has — one is a government public health entity, the other markets drugs for profit.

What Woodcock didn’t note is how flexible FDA already is on direct-to-consumer drug advertising compared to the rest of the world. New Zealand is the only other country that allows drug companies to directly market to consumers.

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. Virtually overnight, direct-to-consumer advertising spiked. It went from $579 million in 1996 to $1.3 billion in 1998. A decade later, it had again more than doubled to over $4 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.”


Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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