Here comes the 21st Century Cures Act: Say Goodbye to Vaccine Safety

Science by Barbara Loe Fisher | July 22, 2015

A 2015 Pharma-driven bill blessed by the FDA seriously compromises the integrity of the vaccine licensing process and is sailing through the U.S. Congress. Act to protect vaccine safety and join http://www.NVICadvocacy.org and learn more at http://www.NVIC.org.

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21st Century Cures Act Gets a Revision

By Randi Hernandez | PharmTech | July 7, 2015

The 21^st Century Cures Act will see some revisions before the House votes on the bill later this week. On July 2, 2015, the House Committee on Energy and Commerce released a summary of major changes to the bill that reduce the funding to the National Institutes of Health (NIH) and Cures Innovation Fund to approximately $8.75 billion over the next five years instead of the $10 billion that was originally proposed. The funding amount was amended “to clarify the availability of a $9.3 billion advanced appropriation for FY2016–FY2020. $110 million is made available for FDA regulatory modernization activities annually from FY2016–FY2020.”

Other changes to the proposed bill include not requiring companies that receive NIH funding to report their data, and additional changes to how drugs are reimbursed, specifically, payment amounts for branded drugs and infused specialty drugs. … continue

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Is The 21st Century Cures Act Good Or Bad For The Biopharmaceutical Industry?

Forbes | June 8, 2015

… “An underlying premise of the bill is the need to accelerate approval for new products, but this process is already quite efficient. A third of new drugs are currently approved on the basis of a single pivotal trial; the median size for all pivotal trials is just 760 patients. More than two-thirds of new drugs are approved on the basis of studies lasting 6 months or less – a potential problem for medications designed to be for a lifetime. Once the FDA starts its review, it approves new medications about as quickly as any regulatory agency in the world, evaluating nearly all drug applications within 6 to 10 months, an impressive turnaround for such complex assessments.” … Full article