What an honor it is to speak to you today on behalf of the Biotechnology Innovation Organization (BIO) about the Biosimilars User Fee Act reauthorization. This Committee planted the seed that has grown into multiple user fee programs that provide FDA with a significant portion of the resources it needs to ensure that patients have timely access to safe and effective new drugs and biologics, generic drugs, biosimilars, and medical devices. This Committee also tilled the ground and successfully produced, with an overwhelming bipartisan House vote, the legislation that established an FDA pathway for the approval of biosimilars – the Biologics Price Competition and Innovation Act (BPCIA). BIO was an early and strong supporter of this legislation to create a facilitated and balanced pathway for greater competition in the biologics marketplace.

The Biotechnology Innovation Organization (BIO) thanks the European Medicines Agency (EMA) for the opportunity to submit comments on the “Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products.” 

Patrick Plues, BIO’s Vice President, State Government Affairs, testified before the Maryland House in opposition to House Bill 666, which would require biopharmaceutical manufacturers to disclose specific information on cost inputs for specific drugs and to provide 60-day prior notice of any anticipated price increase for products priced over a certain threshold.

BIO supports EPA’s ongoing efforts to improve the efficiency and effectiveness of the federal Renewable Fuel Standard (“RFS”) program, which was created by Congress, with bipartisan support, in statutory provisions that President George W. Bush signed into law as part of the Energy Policy Act of 2005 and Energy Independence and Security Act of 2007.