Food & Drug Law Blog
FDA Marketing: PAR v US – “Pay no attention to the man behind the curtain” - Why is the Government Trying to Strike its Own Statements from the Public Record?
On Wednesday, March 20, 2013 by Michael A. Walsh posted in Food & Drug Law Blog
On March 5, 2013 the Department of Justice issued a Press release announcing “Par Pharmaceuticals Pleads Guilty and Agrees to Pay $45 Million to Resolve Civil and Criminal Allegations Related to Off-Label Marketing.” The plea and agreement to a 5 year Corporate Integrity Agreement resolved criminal and civil liability for promotion of a prescription drug approved for weight loss in AIDS patients but “marketed” for the unapproved use of geriatric wasting. But now the government is seeking to strike from the public record how it “defined” off-label promotion in its communications with PAR.


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Off-Label March Madness: One Loss, One Win and One Tie (Caronia, Harkonen and PAR)
On Tuesday, March 12, 2013 by Michael A. Walsh posted in Food & Drug Law Blog
In March 2013 the government had a chance to appeal its landmark loss in the Second Circuit in US v Caronia, the Ninth Circuit affirmed the conviction in US v. Harkonen, discussed below, and it settled two cases involving PAR Pharmaceuticals, one for off-label promotion and PAR’s action seeking to dismantle FDA regulation of marketing for approved products.

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Fines, Detentions and Arrests
On Friday, February 22, 2013 by Michael A. Walsh posted in Food & Drug Law Blog
Fines
Detentions and
Arrests

The New Normal for the Food Industry - Compliance Programs and Employees Who (Seriously) Enforce them.


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Food Labeling – FTC Fumbles the First Amendment
On Friday, January 25, 2013 by Michael A. Walsh posted in Food & Drug Law Blog
FTC deftly ignores the most interesting and important aspect of the POM Wonderful case.

On January 10, 2013 the Federal Trade Commission issued its Opinion, a long awaited next-step in the arduous journey of In the Matter of POM Wonderful LLC et al to the United States Supreme Court that is provided that POM has enough fight left to continue this battle.


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Drugs are not Lawnmowers
On Tuesday, January 15, 2013 by Michael A. Walsh posted in Food & Drug Law Blog
 “Drugs are not lawnmowers” says the Alabama Supreme Court as it mows down the law of medical products liability

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