Stakeholders Respond to Request for Feedback on Bio-Similars Pathway

Responses Under Review as Pallone, Deal Continue Effort to Develop Balanced Policy

Washington, DC – The Committee on Energy and Commerce has released the responses to the questionnaire that was submitted to stakeholders on April 3, 2008, soliciting feedback on how to establish a pathway to allow for the Food and Drug Administration (FDA) to approve bio-similar products.

The April 3 letter sent from Reps. Frank Pallone, Jr., (D-NJ), Chairman of the Subcommittee on Health, and Nathan Deal (R-GA), ranking Republican of the Subcommittee on Health, can be viewed at: https://democrats-energycommerce.house.gov/Press_110/110-ltr.040308.list.Biologic%20ltr.pdf

The responses can be viewed at: https://democrats-energycommerce.house.gov/Press_110/040308.FOB.Responses.shtml

“We hope that these responses will better inform our efforts to craft legislation that can achieve consensus among the Members,” Pallone and Deal said. “We are fully committed to ensuring that FDA has the authority to approve safe, affordable bio-similar products in an appropriate and timely fashion.”