WASHINGTON, DC – The House of Representatives passed H.R. 2430, the FDA Reauthorization Act (FDARA) of 2017, on Wednesday, by voice vote.
H.R. 2430 reauthorizes FDA’s critical user fee programs, and ensures the FDA has the tools they need to deliver safe and effective drugs, devices, and treatments, to patients more swiftly. Essentially, it’s a huge win for patients and the millions of Americans who work to deliver new cures and therapies.
So, what are people saying about this bipartisan bill?
“The robust performance goals, process improvements, increased accountability and additional resources built into the new user fee agreement mean that patients will benefit from more timely access to the latest medical innovations and companies will benefit from greater certainty as they plan for the next-generation of advancements.”
“We are pleased that FDARA includes key provisions to expedite drug approval and access to safe and effective treatments. In particular, we appreciate the focus in the commitment letter on ways to modernize the clinical trial process and efforts to support biomarker development and qualification.”
–Alzheimer’s Impact Movement
“With today’s vote, the House has taken an important step toward bringing more life-saving biosimilar medicines to market over the next five years at a savings over expensive biologics,” said Biosimilars Council Executive Director Christine Simmon. “This bill will help increase competition, ensuring that patients will have more timely access to safe, effective and affordable biosimilar medicines.”
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