The July 2015 passage of HR 6, known as the 21st Century Cures Act, by the House of Representatives gave hope to families living with rare diseases, as this bill included provisions to fast track the FDA’s review process and expand access of investigational drugs for serious conditions and other medical technologies. Opponents voiced concerns, however, about the possible negative impact of the relaxed regulations. You may notice that as this bill is being process by the Senate this fall, it seems to be losing support and a number of alternative bills are being drafted. Those with concerns were hoping that particular weaknesses of the original bill will be addressed in the new versions, but so far they have not. A few key concerns include:
* The proposed law would allow researchers to conduct clinical testing of experimental pharmaceutical products on people without first obtaining their informed consent (if the testing poses no more than minimal risk and includes safeguards).
* Previously required randomized clinical trials would be allowed to be replaced by statistical methods that assign probabilities, clinical experience, and anecdotal evidence to demonstrate safety.
* Mandatory vaccines would be included in the relaxed safety licensing regulations.
ISSUE: Are relaxed safety regulations for all research worth the risk so that we can fast-track the development of medical cures for rare diseases?
AHHA strives to maintain a neutral position on issues. For those interested in learning more about this month’s issue, the following online articles have been compiled to get you started on your research.
H.R. 6, 21st Century Cures Act (7/2/15) [362-page bill]
Future of 21st Century Cures bill in jeopardy (9/11/15)
by Katie Dvorak
21st Century Cures Update (9/22/15)
Modernizing Biomedical Innovation: Understanding the 21st Century Cures Act (8/28/15)
by Avery Avrakolos
The 21st Century Cures Act Is Incredibly Popular. So Why Might it Die in Congress? (8/13/15)
by Rachel Schulze
American Health Line
Here Comes the 21st Century Cures Act: Say Goodbye to Vaccine Safety Science (7/21/15)
by Barbara Loe Fisher
National Vaccine Information Center
21st Century Cures Act Prompts Debate Over Patient Consent Rules (8/13/15)
by Nicole Lewis
21st Century Cures Act: A huge step backward for FDA standards (8/4/15)
by Trudy Lieberman
Health News Review
National Vaccine Information Center Says Proposed 21st Century Cures Act Will Endanger the Public Health by Lowering FDA Licensing Standards (7/22/15)
EON Enhanced Online News
We also encourage you to post your comments. Use this opportunity to share additional resources you have found relating to this health issue.