Speakers recommend new FDA regulations for promoting drugs and devices online

During the second day of a two-day FDA meeting regarding the promotion of regulated drugs and medical devices via the Internet and social media tools, speakers debated the role of companies in reporting and monitoring adverse events and offered suggestions for new policies governing online interaction.

Some speakers said that drug and device companies have taken an “ostrich-with-its-head-in-the-sand” approach to online comments for fear of violating FDA regulations regarding adverse events.

Many speakers argued that the information on the Internet is too vast for companies to monitor.

“There is a fundamental precept here [that] it is virtually impossible for a single entity to monitor the entire Internet,” AdvaMed representative Tony Blank said.

However, others countered that industries can monitor Internet postings and have the tools to do so.

“While manufacturers cannot be responsible for everything that appears on the thousands of Web sites, they can be proactively monitoring what is being said about their products,” Kim Witczak, an individual consumer testifying at the meeting said.

Many experts noted that it remains difficult to confirm and meet all of the FDA’s criteria for reporting an adverse event on the Internet.

Pharma representative, Jeffrey K. Francer, said that manufacturers should monitor for adverse events on their own sites and those on which they fully fund and control.

“However, if a sponsor becomes aware of an adverse event on a Web site it does not manage, the sponsor should review the adverse reaction and determine whether it should be reported,” he said. In addition, he said that the FDA should only require companies to report incidences noted online if individuals can be privately contacted.

HealthCentral representative Christopher M. Schroeder said that companies should not be held accountable for comments made by the public on third-party sites that they do not own.

“Pharmaceutical and medical device companies should only be accountable for their own online communications and for third party communications that they paid for, or for which they have clear editorial control,” he said. “Just because a pharmaceutical or medical device company runs a direct-to-consumer ad on a Web page, it should not make them accountable for the content of that page.”

Consumers Union representative Steven Findlay said that the FDA should tread carefully in setting regulations for online promotions. “What happened to direct to consumer broadcast ads should be a cautionary tale,” he said.

He recommended that sites contain fair and balanced information regarding the risks and benefits of products. He also suggested that the FDA require a link to their online content of a device or drug on any Web site that is owned or substantially funded by that product’s manufacturer. In addition, he said that applications for smart devices should abide by the same rules as the Web.

The presiding FDA officer, Thomas W. Abrams, RPh, MBA, said that the agency heard that the Internet is a different medium and would review all of the submitted information.

“FDA has much work to do in this area and one that we are determined to do,” he said.