November 30, 2016
Update: Urgent Action and Calls Still Needed to Stop the 21st Century Cures Act!
Since last week, your critical action to block the 21st Century Cure Act (H.R. 6) during the ongoing lame-duck session of Congress has been working. Chuck Grassley (R-IA), Elizabeth Warren (D-MA), Bernie Sanders (D-VT), and Rosa DeLauro (D-CT) have all protested, calling for stopping the bill in its tracks, until significant changes are made.
More urgent action is needed with calls to legislators this morning – the Senate will be increasingly influenced by how the House votes and perceives the bill. The current version of the bill still contains harmful provisions to public health, complicating the safety of future drugs and devices. These problematic provisions include:
- Real World Evidence: The bill calls on the FDA to evaluate the use of “real-world evidence” in the approval of new indications for drugs already approved by the agency. This could weaken approval standards significantly for the FDA by supplanting gold-standard randomized clinical trial data in all approvals.
- Accelerated Approval for Regenerative Advanced Therapies: This new provision creates an accelerated approval pathway for regenerative advanced therapies and allows submission of data measures like surrogate endpoints and post-approval studies in their evaluation.
- Limited Population Pathway: Pressures the FDA to approve new antibiotics based on smaller trials and limited populations = making risks and potential dangers associated to the antibiotic harder to detect.
For more about the remaining dangers of the bill, see this updated one-pager from our allies at Public Citizen. Lastly, significant cuts have been made to NIH research funding promised by the bill.
Here’s two ways you can continue to take action and build pressure:
- Sign-on to a petition warning Congress not to let PhRMA hijack the 21st Century Cures Act
- Continue to call your Congresspeople, both Senators and Representatives. Encourage those who either support or on the fence to reconsider any endorsement. Here’s what you can say:
Hi, my name is ________________ and I am a calling to urge [Representative or Senator] ________________ to oppose a lame-duck vote on the 21st Century Cures Act bill. While I/we greatly value Congressional support for increased funding for the National Institutes of health and accelerated development of cures for patients, I/we are concerned that the potential risks of this bill will outweigh the benefits. The 21st Century Cures Act bill could increase monopoly drug pricing practices and lead to harmful regulatory changes that put patient safety at risk. I/we cannot support legislation that potentially undermines public health and access to affordable health care, particularly a new bill that is being rushed to pass in the lame-duck session. Significant changes are still needed.
Key Congressional contacts (Washington D.C. and local district offices phone numbers included):
- Sen. Barbara Mikulski (D-MD): (202) 224-4654 or (410) 962-4510
- Sen. Patrick Leahy (D-VT): (202) 224-4242 or (802) 229-0569
- Sen. Harry Reid (D-NV): (202) 224-3542 or (775) 882-7343
- Sen. Chuck Schumer (D-NY): (202) 224-6542 or (212) 486-4430
- Sen. Patty Murray (D-WA): (202) 224-2621 or (206) 553-5545
- Sen. Ron Wyden (D-OR): (202) 224-5244 or (503) 326-7525
House of Representatives:
- Rep. Nancy Pelosi (D-CA): (202) 225-4965 or (415) 556-4862
- Rep. Jan Schakowsky (D-IL): (202) 225-2111 or (773) 506-7100
- Rep. Steny Hoyer (D-MD): (202) 225-4131 or (301) 474-0119
Additional Congressional contacts:
- Rep. Rosa DeLauro (D-CT): (202) 225-3661 or (203) 772-2260
- Rep. Frank Pallone (D-NJ): (202) 225-4671 or (732) 249-8892
- Rep. Peter Welch (D-VT): (802) 652-2450 or (888) 605-7270
- Rep. John Sarbanes (D-MD): (202) 225-4016 or (410) 295-1679
- Rep. Paul Tonko (D-NY): (202) 225-5076 or (518) 465-0700
- Rep. John Yarmuth (D-KY): (202) 225-5401 or (502) 582-5129
- Rep. Kathy Castor (D-FL): (202) 225-3376 or (813) 871-2817
- Rep. Ben Ray Luján (D-NM): (202) 225-6190 or (505) 984-8950
- Rep. Joseph Kennedy (D-MA): (202) 225-5931 or (508) 431-1110
Thank you for continuing to take action against 21st Century Cures!
Additional resources on 21st Century Cures Act:
- Treatment Action Group letter to Minority Leader Nancy Pelosi on reconsidering support on 21st Century Cures
- Public Citizen sign-on letter urging House leadership to not pass 21st Century Cures Act during the lame-duck session
- National Center for Health Research: 21st Century Cures Act Controversy and Flaws
- “Lawmakers must ask tough questions about the 21st Century Cures Act”, blog published on The Hill
- Senator Elizabeth Warren’s remarks on 21st Century Cures
- Senator Bernie Sanders’ statement on 21st Century Cures