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Randi Hernandez was science editor at BioPharm International from September 2014 to May 2017.
The House Energy and Commerce Committee gave unanimous approval to the landmark 21st Century Cures Act reform bill on May 21, 2015.
In a groundbreaking decision, the House Energy and Commerce Committee unanimously approved the 21st Century Cures legislation on May 21, 2015. “This historic day marks a big bipartisan step forward on our path to cures,” said Fred Upton (R, MI), who chairs the committee, in a statement.
In addition to substantial budget increases for the National Institutes of Health (NIH) of $10 billion over five years, the bill proposes extra mandatory funding to FDA.
Following the announcement, Pharmaceutical Research and Manufacturers of America (PhRMA) President and CEO John J. Castellani commented on the legislation’s impact on FDA user fees in an official company statement. He said, “Exempting future Food and Drug Administration (FDA) user fees from sequestration is critical to ensuring the FDA is able to fulfill its public health mission by fostering timely patient access to safe and effective new medicines and advancing regulatory science. We are pleased to see this important provision included in the legislation."
The Act’s purpose is to accelerate the development of new medicines and improve scientific expertise and outreach at FDA. Specifically, the Act proposes to extend the exclusivity period for a drug approved for a new indication for rare diseases, foster the development of new antimicrobial drugs to fight antibiotic resistance, facilitate collaborative clinical trial research, qualify new drug development tools, advance precision medicine, expedite patient access to medications, reauthorize and re-evaluate the rare pediatric priority review voucher program, and curtail prescription drug abuse, among other goals.
One of the most interesting items in the Act that directly relates to bioprocessing is the allotment of grants for studying the process of continuous drug manufacturing. According to the legislation text, “The Commissioner of Food and Drugs may award grants to institutions for the purpose of studying and recommending improvements to the process of continuous manufacturing of drugs and biological products and similar innovative monitoring and control techniques.” The bill also stipulated that $5 million in grants will be awarded to institutions studying continuous manufacturing for each fiscal years 2016 through 2020.
Energy and Commerce Committee