Comments on: Bad Product Of The Year Goes To… Rozerem http://www.pharmalot.com/2007/10/bad-product-of-the-year-goes-to-rozerem/ News, Comment and Conversation Fri, 10 Feb 2012 21:59:19 +0000 http://wordpress.org/?v=2.6.2 By: Hank http://www.pharmalot.com/2007/10/bad-product-of-the-year-goes-to-rozerem/#comment-24087 Hank Thu, 01 Nov 2007 04:49:47 +0000 http://www.pharmalot.com/2007/10/bad-product-of-the-year-goes-to-rozerem/#comment-24087 Can the DOJ levy fines under such circumstances (theoretically)? They have in a few fraud cases, although in a "minimalist" way. Can the DOJ levy fines under such circumstances (theoretically)? They have in a few fraud cases, although in a “minimalist” way.

]]> By: Ed Silverman http://www.pharmalot.com/2007/10/bad-product-of-the-year-goes-to-rozerem/#comment-23918 Ed Silverman Tue, 30 Oct 2007 18:20:00 +0000 http://www.pharmalot.com/2007/10/bad-product-of-the-year-goes-to-rozerem/#comment-23918 Hi Bruce, Thanks for pointing that out. I should have done so myself, but in my haste this morning, I breezed right past that point. Glad you wrote in. Regards ed at Pharmalot Hi Bruce,

Thanks for pointing that out. I should have done so myself, but in my haste this morning, I breezed right past that point. Glad you wrote in.

Regards

ed at Pharmalot

]]> By: Bruce Grant http://www.pharmalot.com/2007/10/bad-product-of-the-year-goes-to-rozerem/#comment-23895 Bruce Grant Tue, 30 Oct 2007 16:37:50 +0000 http://www.pharmalot.com/2007/10/bad-product-of-the-year-goes-to-rozerem/#comment-23895 Consumers International might want to check FDA's authorizing legislation. They might be surprised to learn that the Agency has *no authority* to levy fines. It would have acquired that authority, at least in a limited way, under some of the more draconian language inserted in the PDUFA reauthorization bill, but that language was killed -- not by PhRMA, surprisingly enough, but by the advertising and media companies that are the beneficiaries of DTC. FDA has the authority to seize "misbranded" goods (which David Kessler famously did to Procter & Gamble's Citrus Hill Orange Juice, almost as his first act as Commissioner) and it has the authority to refer for prosecution by the DOJ. But the power to fine -- which even the parking authorities of the smallest towns in the smallest states have -- unh-unh. Consumers International might want to check FDA’s authorizing legislation. They might be surprised to learn that the Agency has *no authority* to levy fines. It would have acquired that authority, at least in a limited way, under some of the more draconian language inserted in the PDUFA reauthorization bill, but that language was killed — not by PhRMA, surprisingly enough, but by the advertising and media companies that are the beneficiaries of DTC.

FDA has the authority to seize “misbranded” goods (which David Kessler famously did to Procter & Gamble’s Citrus Hill Orange Juice, almost as his first act as Commissioner) and it has the authority to refer for prosecution by the DOJ. But the power to fine — which even the parking authorities of the smallest towns in the smallest states have — unh-unh.

]]>