recommended reading

FDA to regulate online drug promotions

The Food and Drug Administration plans to issue this year proposals regulating prescription advertisements on the Internet, and the agency likely will not differentiate between social media tools, FDA officials said on Tuesday.

Since November 2009, the pharmaceutical industry has pushed FDA to allow companies to promote medical information about drugs on Twitter and other similar microblog applications, using abbreviated text. Current FDA regulations on product labeling do not distinguish between hard copy and digital content, like Twitter posts.

"That's akin to using standards created for horse and buggies to regulate automobiles," said Jeffrey Francer, assistant general counsel for industry group PhRMA, during a conference call with reporters on Tuesday. "So we're asking for new standards as quickly as possible."

On Feb. 26, PhRMA submitted comments to the agency, proposing FDA adopt several Internet-specific standards, including giving drug companies permission to microblog, in forums such as Twitter, about scientific news regarding their products. The group also suggested letting companies place a universal FDA seal of approval on space-constrained messages, which would link to more complete labeling. And PhRMA asked FDA to allow manufacturers to provide one-line warnings in sponsored search results that would link to information on drugs' risks.

FDA spokeswoman Shelly L. Burgess said in a statement to Nextgov that forthcoming guidance will focus on Web-based approaches that would remain relevant for decades, rather than on specific applications. "Our guidance will not become quickly outdated as the tools and technology evolve," she said. The regulatory areas that FDA expects to cover in its Internet promotion guidance include accountability, ownership and responsibility, Burgess added.

In the fall of 2009, FDA conducted a public hearing to decide whether to regulate Web-based promotions separately. The two-day meeting gathered input from Francer, consumer groups, marketing firms and others.

One of the questions officials posed was how should companies disclose warnings online, where space is limited and communication is live. For example, broadcast text-messaging applications such as Twitter do not give users enough room to type a full list of appropriate uses, directions, side effects and drug interactions.

Francer suggested FDA let manufacturers announce medical news, including short but accurate treatment descriptions, in the same way the agency currently posts health information on Twitter. He pointed to an Oct. 19 agency Tweet that read: "FDA Approves Votrient (pazopanib), a New Treatment for Advanced Form of Kidney Cancer."

FDA officials said on Tuesday that there are no regulations that prohibit the use of certain types of media to advertise drugs and medical devices. According to agency guidelines, promotional materials must be accurate, balanced and not misleading. FDA consistently has enforced these rules, "regardless of the venue or medium used for promotion," Burgess said.

On Jan. 27, FDA sent a letter to drug manufacturer Eli Lilly and Co. informing it that the agency determined that a Web page for the drug Adcirca, a treatment for pulmonary arterial hypertension, was misleading and false because it omitted risks. The letter requested that the pharmaceutical company "immediately cease the dissemination of violative promotional materials."

Lilly officials on Wednesday said that they contacted United Therapeutics, the company licensed to market Adcirca in the United States, to request the Web page be removed. Officials said they also are working with United Therapeutics on a reply to FDA's request.

During the hearings last fall, Francer also proposed that FDA require a graphic, similar to the Good Housekeeping seal of approval, on search results, microblogs and other word-limited online text that contains treatment information. The symbol would assure users the message contains accurate data, he testified.

In its Feb. 26 proposal, PhRMA stated that in sponsored search results, FDA should permit manufacturers to present a brief standard warning such as, "All drugs have risks. Click here for important safety information from the manufacturer," which would link readers to a Web page that provided more details on the drug's risks and benefits.

FDA officials said they could not comment on whether they supported the concept of a universal logo or standard warning because the agency still is evaluating the comments received last year.

Threatwatch Alert

Thousands of cyber attacks occur each day

See the latest threats


Close [ x ] More from Nextgov

Thank you for subscribing to newsletters from
We think these reports might interest you:

  • Modernizing IT for Mission Success

    Surveying Federal and Defense Leaders on Priorities and Challenges at the Tactical Edge

  • Communicating Innovation in Federal Government

    Federal Government spending on ‘obsolete technology’ continues to increase. Supporting the twin pillars of improved digital service delivery for citizens on the one hand, and the increasingly optimized and flexible working practices for federal employees on the other, are neither easy nor inexpensive tasks. This whitepaper explores how federal agencies can leverage the value of existing agency technology assets while offering IT leaders the ability to implement the kind of employee productivity, citizen service improvements and security demanded by federal oversight.

  • Effective Ransomware Response

    This whitepaper provides an overview and understanding of ransomware and how to successfully combat it.

  • Forecasting Cloud's Future

    Conversations with Federal, State, and Local Technology Leaders on Cloud-Driven Digital Transformation

  • IT Transformation Trends: Flash Storage as a Strategic IT Asset

    MIT Technology Review: Flash Storage As a Strategic IT Asset For the first time in decades, IT leaders now consider all-flash storage as a strategic IT asset. IT has become a new operating model that enables self-service with high performance, density and resiliency. It also offers the self-service agility of the public cloud combined with the security, performance, and cost-effectiveness of a private cloud. Download this MIT Technology Review paper to learn more about how all-flash storage is transforming the data center.


When you download a report, your information may be shared with the underwriters of that document.