At the beginning of the year the Food and Drug Administration (FDA) sent warning letters to 10 companies concerning advertising on the internet. Recently the agency announced that they will be hosting a series of hearings on the internet and the web 2.0. The eventual goal is to come up with a much needed guidance on drug and device advertising on the internet and social media.
FDA's Center for Drug Evaluation and Research (CDER), in collaboration with FDA's Center for Biologics Evaluation and Research (CBER), Center for Veterinary Medicine (CVM), and Center for Devices and Radiological Health (CDRH), recently gave notice of a public hearing it will be holding this November regarding the Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools.
The hearing will discuss issues related to the promotion of FDA-regulated medical products (including prescription drugs for humans and animals, prescription biologics, and medical devices) using the Internet and social media tools.
Those members of the public interested in participating can find a list of questions and topics that will be discussed at the hearing from the link listed above.
Information
Interested persons may submit written comments (two copies required) to the Division of Dockets Management to:
Docket No. FDA-2009-N-0441
Division of Dockets Management (HFA-305), Food and Drug Administration , rm. 1061,
Electronic comments should be submitted by going to http://www.regulations.gov and using electronic registration and electronic comments. Electronic comments should be identified with Docket No. FDA-2009-N-0441.
Written or electronic comments will be accepted until February 28, 2010.
Dates and Times: The public hearing will be held on November 12 and 13, 2009, from 8 a.m. to 5 p.m. each day.
Location: The public hearing will be held at the , 429 L'Enfant Plaza, SW., , 202-314-6305; Metro: L'Enfant Plaza station on the yellow, green, orange, and blue lines.
The meeting will take up several questions:
- What types and which online messages, posting and chatter are regulated companies responsible for? And what's not their problem?
- How do companies currently comply with existing regulations, how do those regulations apply to the internet, what changes need to be made, should they require fair balance in shorter communications?
- What responsibility does a company have to correct misinformation presented by a third party? (for example Wikipedia, Yahoo and other websites that provide information free of control of industry)
- What links are appropriate? When are links misleading.
- What reporting structure (to the FDA) should be in place for monitoring websites that include information on safety problems or side effects and the reliability of that information?
To register to attend and/or participate in the meeting, submit written or electronic registration as specified above by close of business on October 9, 2009. Registration is free and will be accepted on a first-come, first-served basis.
If you wish to make an oral presentation at the hearing, you must state your intention on your registration submission. To speak, submit your name, title, business affiliation, addresses, telephone and fax numbers, and e-mail address. Presenters should also identify by number each question they wish to address in their presentation and the approximate time requested. The FDA will determine the amount of time allotted to each presenter and the approximate time that each oral presentation is scheduled to begin. Once FDA notifies registered participants of their scheduled times, presenters should submit to FDA two copies of each presentation to be given
Transcripts of the hearing will be accessible after the hearing at http://www.regulations.gov.
For further information contact: Jean-Ah Kang, Division of Drug Marketing, Advertising, and Communications, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 3270, Silver Spring, MD, 20993-0002, 301-796-4269, FAX:
301-796-8444, e-mail: InternetPublicMeeting@fda.hhs.gov.