FDA demands truth-telling plans from Baxter

Don't pooh-pooh FDA's warnings on marketing violations. That's the message Baxter Healthcare got in a recent warning letter. As Pharmalot points out, the letter citing Baxter for mismarketing its lung drug Aralast not only demands that the company stop using the offending brochure, but requires Baxter, as a repeat offender, to come up with a plan to make sure its drug promos tell the truth.

"[S]ince we have cited you for similar violations in the recent past, we request a response in writing indicating what policies and procedures your firm intends to adopt to ensure your prescription drug promotion activities comply" with the law, wrote FDA's Mary Malarkey, director of the Office of Compliance and Biologics Quality. Baxter also has to explain to FDA why it thinks those proposed changes would actually work.

The FDA has stepped up its oversight of drug-marketing materials, issuing 68 letters so far this year, compared with just 41 in 2009 and 21 in 2008. Plenty of reasons for this, not least of which is that the agency changed hands when the White House did. Eye on FDA recently reported that DDMAC, the agency's marketing oversight arm, has staffed up, so more eyes are looking at more media.

- read the FDA letter
- see the Pharmalot post
- get more from Bloomberg
- check out the Eye on FDA post
- find the Wall Street Journal coverage