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Old 02-01-2012, 06:58 PM   #15
schoonder
Senior Member
 
Join Date: Jul 2008
Posts: 186
Re: FDA Blocks Life-Saving Cancer Drug Rally

It looks to me Congressman's gracious response wasn't all that helpful, actually it was short on substance. Recommendation to contact FDA directly, the organization responsible for making that inexcusable decision not to review T-DM1 phase II data because not all BC treatments, regardless of her2+ status were accounted for, in hope to see decision overturned, borders on nonsensical.
A much better response would've been if Congressman had asked the FDA Oversight Subcommittee to have a look at this far reaching ruling, which may well have its roots in regulations that haven't been revised to account for state-of-the-art, targeted drugs, high in efficacy, low in toxic side effects.
://en.wikipedia.org/wiki/United_States_House_Oversight_Subcommittee_on_Heal th_Care,_District_of_Columbia,_Census_and_the_Nati onal_Archives
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