How To Testify To FDA On Seroquel

The FDA psychopharmacology advisory committee is holding hearings on AstraZeneca's applications to have its antipsychotic Seroquel approved by the FDA for one of three depression indications (including long-term maintenance) and anxiety. If you want to make your voice heard on this, there's information below on how you can do so. It is significant that the FDA is having the committee review the applications and offer its opinion instead of just approving the drug itself.

Keep in mind that the committee is comprised mostly of psychiatrists and other researchers and that the committee is only making a recommendation to the full FDA. The committee does not approve a drug. Only the FDA proper can do that.

You can either testify in person or in writing. It's 2009, but the FDA still makes no provision for testimony by phone or webcam, which strikes me as being very 1965 on the agency's part, but whatever. To testify in person, you must contact Yvette Waples, at (301) 827-6790 or by email at Yvette.Waples@fda.hhs.gov by the close of business on March 18. That's tomorrow. The hearings are set for April 7 and April 8 in Silver Spring, MD.

I'll be testifying in writing later this week.

There are three ways you can submit written testimony to the committee. One is by submitting an email to Yvette.Waples@fda.hhs.gov. Or you can fax your testimony to (301) 827-6778. Or you can mail your testimony to:

Yvette Waples, Center for Drug Evaluation and Research (HFD–21), Food and Drug Administration, 5600 Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857.

The deadline to submit written testimony is March 27.