Saturday, June 9, 2007

Maraviroc - "to be formally approved by the FDA on June 20"

Speaking of things premature (see previous post), is it OK to announce ahead of time that a drug will be approved on a given date by the FDA? Unless a Pfizer spokesman was misquoted, this does appear to be the case. According to this AFP article, "The new drug, which will be taken orally, is set to be formally approved by the FDA on June 20, a spokesman for the company said.". They are talking about maraviroc, Pfizer's new HIV drug which was recommended for approval by an FDA advisory panel previously. Granted that the FDA probably has informal communications with companies a few days prior to official announcements...but doesn't announcing the same to the public defeat the purpose?....maybe AFP just mangled the quote. Hat Tip: BrandweekNRX blog.


Bruce Grant said...

This is common practice. SEC regulations require companies to announce in a timely manner any developments that may "materially affect" their share price.

New product releases -- as well as news about the progress of clinical trials -- have historically been considered to fall under this category.

Recognizing that they are also covered by FDA regulations prohibiting pre-approval marketing, most companies post press releases announcing these developments in the Investor Relations section of their website and distribute them to financial media only...and typically leave them on the website for no longer than three weeks.

Pharmalyst said...

Thank you for educating me!