On March 8, the Senate held a hearing on follow-on biologics. Now it’s the House’s turn. Tomorrow morning, the House Oversight Committee, chaired by Rep. Henry A. Waxman (D-CA), will hold a hearing entitled “Safe and Affordable Biotech Drugs–The Need for a Generic Pathway.”
Rep. Waxman is the sponsor of the “Access to Life-Saving Medicine Act” (H.R. 1038) in the House. A nearly identical bill (S. 623) has been introduced in the Senate. If passed, the bill would establish an abbreviated pathway for FDA approval of follow-on biologics. Democrats in both chambers have indicated that passage of the bill is a top priority for the new Congress.
Witnesses called to testify tomorrow include Dr. Janet Woodcock, Deputy FDA Commissioner, representatives from the pharmaceutical industry and third-party payors, and consumer advocates.
UPDATES:
- The hearing web page includes a video recording of the hearing and links to all of the prepared testimony.
- More at On Pharma
- March 26 AP article on the hearing
- March 26 Bloomberg report on the hearing
- March 26 BIO press release
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