Reporting Adverse Events Found Online Complicated By Internet's Anonymity; Can Widgets Rescue Industry From Compliance Conundrums?

FDA should modify its adverse event reporting policy to allow protection of patient privacy for AEs that sponsors discover online, industry representatives told the agency during its two-day public meeting on regulation of the Internet.

"To respect patient and reporter privacy, FDA should only require manufacturer reporting of incidents discovered online, if online reporters are privately contactable," Pharmaceutical Research and Manufacturers of America Assistant General Counsel Jeffrey Francer told the 13-member agency panel.

Currently, drug companies must report adverse events associated with their products if the reporter of the event and the patient are identifiable, the drug is mentioned by name, and the adverse event is specific.

Francer maintained that patient privacy could be violated if a firm were to ask questions about an incident online in order to ascertain if an AE is reportable.

To be held liable for AE reporting, he suggested, "It should be possible to communicate directly with the reporter without the need to post questions in a public forum to obtain more information."

Division of Drug Marketing, Advertising and Communications Deputy Director Kristin Davis countered that instead of asking for a reply in the public forum, companies that spot a discussion of an adverse event could provide the poster with information on how to contact the firm privately.

"That probably seems like a reasonable approach to try to avoid an online discussion of someone's personal health information," Francer agreed.

DDMAC Director Thomas Abrams later returned to the privacy issue in a question to Rick Wion, vice president of social media at public relations firm GolinHarris.

"How do you suggest we balance the privacy concerns of a patient versus getting additional information needed to follow up in a report?" Abrams asked. "Obviously the Internet provides a mechanism to report adverse events and you don't know the identity" of who is reporting.

Every Company Needs A Widget

A technology solution that allows patients to bypass drug companies and go directly to FDA with adverse event reports was Wion's answer.

Companies could place a MedWatch widget on their branded or disease sites where patients share stories, he said.

Patients could use the widget to report an adverse event "directly to the FDA and you would get the information and you could decide, 'is this an AE?' [or] 'How much information are we getting and what needs to be reviewed to act on it?'"

This creates a situation in which patients can have a basic conversation on the Web site and then contact FDA and have a private conversation with the agency to provide the needed information, Wion suggested.

As a tradeoff for posting the widget, John Mack, publisher of Pharma Marketing News, suggested that drug companies not be required to investigate AEs found online.

"If there were a safe harbor, pharmaceutical companies would put this prominently on their drug.com sites. Maybe they could be relieved of their responsibility to process and look at all these adverse events they come across on third-party sites. So this way they could feel free to go on these sites and do what they think they can do in terms of discussions with consumers without having to worry about" reporting requirements.

The precedent for the safe harbor is television advertisements, Mack said, noting that sponsors do not have to provide the full package insert if they refer consumers to a phone number, a Web site or a consumer magazine article.

The need for FDA to clarify how far companies must go into the role of "cyberdetectives" in pursuit of adverse events was stressed by Rohit Bhargava of Ogilvy 360 Digital Influence.

Drug firms are unsure of their responsibilities and as a result are not visiting sites, "because if you find any sort of mention of your product and it could be considered as an adverse event in anyone's eyes, you may be forced to report it and may be forced to perhaps assign resources to it you don't necessarily have," he pointed out.

"Brands should be responsible for reporting adverse events found online only if reportability and identifiability criteria are met without additional follow-up," Bhargava said.

To improve information provided online, he suggested a consumer education effort centered on adverse events. "There should be some education to help people to share any adverse events in a way that is immediately reportable."

Many online communities have information on the sites telling participants how to report adverse events, he noted.

To facilitate the process for patients, he proposed that a standardized approach to reporting be developed, perhaps by FDA, and that patients be told what information to post and how, if they want a response.

Information on where and how to report an adverse event should be included with labeling information wherever that appears, as well as with general and specific information about drugs on the Web, Steven Findlay of Consumers Union recommended.

The reporting alert should be attention-getting and easy to understand, he said. "We don't think that many words are required to explain a one-click link to the MedWatch system."

- Cathy Dombrowski ( ¹ [email protected] )