Allergan Insists DOJ Subpoena and Lawsuit v. FDA on Botox Are Unlinked

(MoneyWatch)  Allergan told investors that the suit it filed against the FDA to allow it more freedom to discuss off-label uses of Botox has nothing to do with a Department of Justice probe that has cost the company $7.4 million. Reuters:

"The case in that matter involves past practices" and investigations, company Chief Administrative Officer Douglas Ingram told analysts in a conference call on Friday.

By contrast, Ingram said a lawsuit filed by Allergan on Thursday against the U.S. Food and Drug Administration and Department of Justice is "forward-looking." He said it is meant to lift FDA restrictions against promoting drugs for unapproved -- or "off-label" uses.

At the same time, Allergan is asking the FDA to give it an indication for the use of Botox in migraines -- the very issue that the DOJ is looking at.

So here's the order of events:

1. Allergan receives a subpoena from the DOJ and makes this statement: "Allergan's current understanding is that the inquiry involves questions regarding alleged off label promotion relating to the use of BOTOX for the treatment of headache."
2. Allergan spends $7.4 million responding to the subpoena.
3. Allergan announces: "Allergan intends to file its sBLA with the FDA for the use of BOTOX® in chronic migraine by the end of the third quarter of 2009."
4. Allergan sues the FDA for greater freedom on off-label issues for Botox.

It's hard to see how these developments are unlinked, as the company insists they are.

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