Anavex Life Sciences Corp (AVXL)

[sokol]

Two House Bills Introduced 2/27 to Amend FD&C Act re: pediatric cancer and rare disease approval process and exclusivity periods.

Following up on the President’s speech last night about speeding up FDA approval, I looked up two bills that have been introduced to amend the Federal FD&C Act that may have an impact on FDA approval process and exclusivity periods for pediatric cancer and rare disease drugs. Both bills were introduced on February 27, 2017 and are slated to go before the House Energy & Commerce Committee.

The full text of each bill is not yet available.

House Bill 1223
Bill to Amend FD&C Act to authorization extension of exclusivity periods for certain drugs that are approved for a new indication for a rare disease or condition. Introduced by Rep. Bilirakis (R-FL); Rep. Butterfield (D-NC); Rep. McCaul (R-TX)

House Bill 1231 (Senate Bill 456 is companion bill)
Bill to Amend the FD&C Act to establish program to increase the development of new drugs to treat pediatric cancer
Introduced by Rep. McCaul (R-TX); Rep. Butterfield (D-NC); Rep. Clarke (D-WY); and Rep. Duffy (R-WI)