Communications Advances Present Challenges to Manufacturers

Much of the world now uses the Internet to communicate with friends and relatives, to market goods and services, and to convey information on important developments around the globe, including health and medicine. Healthcare professionals and patients are turning to online disease sites for assistance in diagnosing and treating cases. Twitter and Google Flu Trends help predict epidemics and hospital emergency department traffic. Worldwide use of mobile communications devices further expands two-way communications about healthcare activities and problems.

Jill Wechsler

These developments leave pharmaceutical manufacturers in regulatory limbo due to curbs on what firms can tell the public about their products and operations. Widespread interest in pharmaceutical company research findings, product safety, and marketing and production speaks to the need for industry to use the Internet to disclose information as broadly as possible. Yet, regulations that ban manufacturer discussion of off-label drug uses and require full disclosure of product risks limit what manufacturers can say about approved medicines. Industry, as well as the larger healthcare community, want FDA to clarify how its rules on drug marketing and promotion can fit the age of instant Internet communications and unfettered public access to information previously limited to health professionals. FDA officials have been promising guidance in this area for several years, but little has emerged so far.

BROAD CONCERNS

The relationship of pharmaceutical companies to social media communications gained prominence in 2009, when FDA issued Warning Letters admonishing 14 drug and biotech manufacturers for sponsored links on Google and other Internet search engines with information on drug use but without providing adequate risk information. FDA officials said that it is not sufficient to provide a link to more detailed safety information, and that all Internet postings sponsored by manufacturers have to comply with marketing standards for promotional materials. That policy tossed out the assumption that marketers could be in compliance by providing risk information through one click to a relevant source.

FDA held a public hearing on the industry's use of social media in November 2009 to address these issues further. Approximately 50 organizations presented their views, including manufacturers, medical website operators, and Internet search engines. They discussed when and how manufacturers can be held accountable for or able to correct erroneous information in online communications generated by third parties; when it is appropriate to use social media to provide links to non-company healthcare and medication information; how social media can facilitate reporting of adverse drug events; and how companies should submit real-time, online communications to meet requirements for agency review. At the top of the agenda was the Warning Letter issue: namely, how pharmaceutical companies could adhere to policies for drug marketing and communications when it is difficult to fully explain drug risks and benefits in a 140-character Twitter posting.

This public discussion about using online and social media outlets to communicate information about drug products has heightened public use of online resources for relevant medical information, according to a May 2011 analysis by the Pew Research Center. A Pew survey conducted in 2010 found that 24% of Internet users have consulted online reviews of drugs or medical treatments, and 4% have posted personal experiences involving a particular drug. Almost one-quarter of Internet users look for drug safety and recall information online, and the numbers are higher for individuals caring for loved ones and for people with chronic conditions or disabilities.

FDA's Office of Prescription Drug Promotion (OPDP) in the Center for Drug Evaluation and Research (CDER) has been studying concerns and proposals for Internet communications aired at the public meeting and in subsequent public comments with an eye toward providing guidance that will assist industry in adapting marketing practices to the Internet.

The agency now plans to develop several guidances on "concepts that have long-term applicability," explained Jean-AhKang, assistant to the OPDP director, at CBI's January Pharmaceutical Compliance conference in Washington, DC. Instead of issuing platform-dependent policies that would apply to posting information on, for example, Twitter or YouTube, which might become outdated quickly by changing technology, the agency is looking to address broader Internet communications issues. These issues include messages with space limitations as found in banner ads or social-media listings; manufacturer accountability for online communications; links to Internet websites; correcting misinformation on third-party websites; and how to meet FDA prenotification policies for real-time communications activity.

LIMITING OFF-LABEL INFORMATION

FDA provided some clues to how it will address industry use of "emerging electronic media" in a draft guidance published in December 2011 on how drug, biotech, and device manufacturers should respond to unsolicited requests for off-label information. The proposal deals with an issue raised in a citizen petition filed with FDA in July 2011 by pharmaceutical manufacturers seeking clarification on several off-label communications topics. The petitioners sought advice on handling off-label information when dealing with unsolicited requests for information, as well as during scientific exchange; when providing information to formulary committees and payers; and in disseminating clinical-practice guidelines prepared by third parties.

This recent guidance from FDA, Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices, mentions social-media communications as part of its larger discussion of off-label communications. The main thrust of the document is to clarify that manufacturers may provide information on off-label drug uses, but only in response to "unsolicited" requests from individuals completely independent of the manufacturer; any hint that the company stimulated the request makes it a solicited request, and potentially violative.

Here is where social media comes in: queries spurred by a company video posted on YouTube, for example, would shift the question into the "solicited" category, which may be violative. Social media sites also are mentioned as possible forums for a company to receive questions from the public, including those involving off-label drug uses.

Probably the most contentious item in the guidance is FDA's proposal that manufacturers handle requests for information made in public or through the Internet in the same way as queries made by email or the phone: provide a response only to the individual requester in "a private, one-on-one communication" and not communicate it online. The agency's concern is that a public response exposes those not making the query to off-label information, and that such information could remain on a website after it becomes outdated.

Regulatory Roundup

When receiving an unsolicited request on an issue related to off-label use, FDA advises manufacturers to provide contact information to medical or scientific personnel (not salesmen) and direct the individual to follow up off-line. Such information should be truthful, balanced, non-misleading and reflect an effort by the company to avoid promoting off-label drug uses. This approach means, however, that a broad audience can see a query and any erroneous, independent statements it generates, but not the company's answer.

Although the guidance disappointed those anticipating more specific advice on social-media communications, the document is important because it includes new Internet technologies as part of the discussion on a critical off-label communications topic, says Peter Pitts, president of the Center for Medicine in the Public Interest. Pitts notes that FDA acknowledges that Internet sites can produce a good deal of misinformation, but the agency fails to explain how companies should deal with erroneous statements about their products, in all media.

MORE THORNY ISSUES

These kinds of limits on pharma company Internet and social media communications raises concerns about broader curbs on industry use of modern communications technology for a broad range of corporate and operational functions, such as reporting corporate news and developments, recruiting patients for clinical trials, or operating hot lines to receive consumer questions and comments.

Social media appears to have great potential for expanding public reporting of adverse drug events, for example. FDA posts online forms for collecting adverse events under its MedWatch program, but the form is long, detailed, and not widely used. Because consumers already turn to social media to discuss experiences with drugs and biotech therapies, as noted in the Pew study, there's interest in imbedding an adverse event reporting "widget" into social media sites to encourage wider public reporting of drug use problems.

Manufacturers are leery of such initiatives, because they would have to scour Twitter and Facebook and other sites to identify such reports and respond to them, which could be a monumental task. Even with a common format, many publicly reported adverse events would be useless if they fail to clearly identify the patient, reporter, dosage, and type of event. Furthermore, as noted above, a pharmaceutical company still would be constrained in addressing misleading adverse-event reports, especially those involving off-label use.

The Internet has become essential for gaining access to health information, said Jeffrey Francer, assistant general counsel at the Pharmaceutical Research and Manufacturers of American (PhRMA), at the CBI conference. FDA has a Facebook page and uses Twitter to discuss new product approvals. Regulators and manufacturers use blogs and social media to alert the public to product recalls and safety issues. As these activities expand, industry needs a way to ensure the accuracy of information posted online about company operations and products, and to correct misleading or fraudulent postings.

Jill Wechsler is BioPharm International's Washington editor, Chevy Chase, MD, 301.656.4634, jwechsler@advanstar.com.