Momenta Pharmaceuticals, Inc. (MNTA)

[investorgold2002]

Senate to consider new FDA approval paths

CW was talking about this...So i guess this bill has to be passed for MNTA's FOB...as they are expected to file for "progressive approval"....I maybe reading this wrong. Feel free to correct me

http://www.biocentury.com/dailynews/topstory/2011-11-11/senate-to-consider-new-fda-approval-paths

Published on Friday, November 11, 2011
A draft of legislation produced by Sen. Kay Hagan (D-N.C.) seeks to create two new FDA approval pathways. Drugs would be eligible for "progressive" or "exceptional" approval if they are intended to provide meaningful advances in the treatment of an unmet serious or life threatening condition, according to a copy of the bill obtained by BioCentury. FDA could also approve drugs based on approval in the EU as well as in Australia, Canada and some other countries.

The draft bill would permit progressive approval based on data "reasonably likely" to predict clinical benefit, the standard currently used for accelerated approval. Unlike accelerated approval, drugs could receive progressive approval without data from a surrogate endpoint. Exceptional approval could be granted when the data necessary to satisfy the standard for approval "cannot ethically, feasibly or practicably be generated." The Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act would also relax conflict of interest restrictions for advisory committee members, create a fixed term for the FDA commissioner, and revise FDA's mission statement to emphasize the promotion of biomedical innovation.