Transcript PPT - National Journal

21st Century Cures Act Speeds Up FDA Approval Process,
But For Better or For Worse?
Arguments For and Against 21st Century Cures Act Changes to the FDA Approval Process
Section 2062 on Evidence Standards for
Drugs and Medical Devices: “Evaluate the
potential use of evidence from clinical experience”
Key Takeaway: The FDA would be able to
consider evidence from clinical case studies
when evaluating efficacy, rather than more
rigorous randomized controlled trials
Section 2121 on Expedited Antibiotic
Drug Development: “Approval of certain
drugs for use in a limited population”
Key Takeaway: New antibiotics would be
approved to enter the market for a limited
population of patients with antibiotic-resistant
infections after “limited” testing
SUPPORTERS SAY
CRITICS SAY
Waiting for results of large clinical
trials slows down the approval
process, keeping potentially lifesaving
drugs and medical devices from
patients for years.
This would allow drugs to be approved
based on anecdotal evidence, which may
not accurately represent actual efficacy
of the drug or medical device.
SUPPORTERS SAY
CRITICS SAY
Speeding up the approval process for
new antibiotics will help combat the
antibiotic-resistant infections crisis
and save lives of affected patients.
This would allow for the results of
animal studies alone to be used as
evidence of efficacy, which may not
translate to efficacy or safety for
humans.
Analysis
• The bipartisan
Century Cures Act (H.R. 6) passed 344 – 77 in the House on July 10th, 2015. It would expedite the FDA approval
process for drugs and medical devices by providing alternative regulatory pathways under certain circumstances.
• Supporters say changes in the regulatory process would increase the number of new lifesaving drugs entering the market, while critics
believe that the bill would lead to the approval of ineffective and potentially unsafe drugs.
21st
Source: Vox, “This new bill would add $9 billion for medical research. Here are 5 reasons critics are terrified.”, July 14, 2015.