Representative Henry Waxman (D-CA) announced plans to introduce legislation that would establish an FDA approval process for generic biologics. He announced his plans in a speech to the Generic Pharmaceutical Association (GPhA) yesterday.
Rep. Waxman stated, “I intend to introduce legislation that will establish a clear pathway for generic biologics very shortly.” Moreover, the pathway should include evaluation of biological products on a “case-by-case approach” due to the “uniqueness of biological products.”
Last month, the governors of four states filed a citizen petition asking the FDA to release guidance for industry that would explain the requirements for applications seeking approval to market generic insulin and human growth hormone.
RELATED READING:
- AP story on Rep. Waxman’s speech
- Press releases from Gov. Doyle (WI) and Gov. Pawlenty (MN) regarding their citizen petition
- GPhA press release regarding the governors’ citizen petition
NOTE: Thanks to a helpful reader for providing a copy of Rep. Waxman’s remarks to GPhA.
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