WLF to FDA Regarding Distribution of Off-Label Reprints: See You in Court!

In February 2014, FDA released a new draft guidance document entitled "Distributing Scientific and Medical Publications on Unapproved New Uses - Recommended Practices." FDA's revised guidance is aimed at addressing some of industry's and the public's concerns regarding the previous guidelines by making clear that the pharmaceutical and medical device industries can distribute medical and scientific reprints -- including reprints of studies for new and unapproved uses of drugs -- to medical professionals, but only under certain conditions.In public comments submitted to FDA, the Washington Legal Foundation (WLF) -- a non-profit legal organization that promotes pro-business and free-market positions and is widely perceived as conservative -- argues that the guidance document is in "direct violation of a 1998 permanent injunction (WLF v. Friedman) it obtained against the agency to prevent it from trampling on industry's purported First Amendment rights" (see here). WLF said it "intends to enforce its injunction and will seek contempt of court citations against FDA officials who violate its terms." WLF cites three FDA proposals with which it has specific issues.Read more ยป
Source: Pharma Marketing Blog - Category: Pharma Commentators Tags: FDA Guidance guidelines off-label promotion Reprints Source Type: blogs