http://blogs.bu.edu/bunow/2010/03/31/drug-firm-snoops-on-fda-officials/ News, information and research from Boston University Wed, 06 Jun 2012 16:53:57 -0400 hourly 1 http://wordpress.org/?v=3.1.4 http://blogs.bu.edu/bunow/2010/03/31/drug-firm-snoops-on-fda-officials/comment-page-1/#comment-17780 Jarvis Thu, 01 Apr 2010 23:33:38 +0000 http://blogs.bu.edu/bunow/?p=4963#comment-17780 Why on earth should they apologize? They are absolutely correct in their suspicions about what is happening at FDA, and FDA knows it. Before you so smugly condemn, you might want to spend a few minutes reading the much bettee reportage on the issue by Andrew Zajac and Alicia Mundy. Enjoy the circumlocutions by FDA as they lied once, twice, three times about what they actually looked for, what they found and why they never did bother to complete a real investigation. The reality here is that Amphastar achieved sameness several years ago; was on the cusp of approval, and then Momenta and Woodcock began publishing articles, taking trips and doing goodness knows what else together. When Amphastar asked for information, they were given nothing. When they requested Woodcock's recusal, they were told to go to hell. When they went to the media, FDA accused them of using "tactics." When they hired a private investigator (in the same fashion someone did in 1989, when they broke open the generic drug scandal), they were accused of "spying." What the investigators did wasn't at all different than what investigative reporters do all the time, and not much different than what Intelius and other services offer online. If anyone should be apologizing, it is Max Baucus for his gratuitous insults and FDA for its treatment of the entire generic industry. As for Professor Outterson, I would recommend he do his homework before he mounts his next pulpit. Why on earth should they apologize? They are absolutely correct in their suspicions about what is happening at FDA, and FDA knows it. Before you so smugly condemn, you might want to spend a few minutes reading the much bettee reportage on the issue by Andrew Zajac and Alicia Mundy. Enjoy the circumlocutions by FDA as they lied once, twice, three times about what they actually looked for, what they found and why they never did bother to complete a real investigation. The reality here is that Amphastar achieved sameness several years ago; was on the cusp of approval, and then Momenta and Woodcock began publishing articles, taking trips and doing goodness knows what else together. When Amphastar asked for information, they were given nothing. When they requested Woodcock’s recusal, they were told to go to hell. When they went to the media, FDA accused them of using “tactics.” When they hired a private investigator (in the same fashion someone did in 1989, when they broke open the generic drug scandal), they were accused of “spying.” What the investigators did wasn’t at all different than what investigative reporters do all the time, and not much different than what Intelius and other services offer online. If anyone should be apologizing, it is Max Baucus for his gratuitous insults and FDA for its treatment of the entire generic industry. As for Professor Outterson, I would recommend he do his homework before he mounts his next pulpit.

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