STAT, April 19, 2023: An FDA proposal to study whether opioids are effective as a chronic pain treatment is facing major resistance from addiction and pain care experts who are not paid by industry. We told STAT that the proposed clinical trial is unethical because it will provide no new information and would make some patients more dependent on opioids.
Read More »Author: Caroline Bradford
NCHR Comments on the CMS Inflation Reduction Act Initial Program Guidance
April 14, 2023: NCHR comment on the CMS plan to fully implement the authorities provided by Congress in the Inflation Reduction Act (Pub. L. 117-169) to lower the costs of prescription drugs for beneficiaries through drug price negotiations.
Read More »NCHR Comments on CPSC Proposed Rulemaking on Safety Standards for Non-full-size (NFS) Baby cribs.
April 5, 2023: NCHR supports the additional standards to improve the safety of non-full-size cribs by regulating cords and straps that form a loop and the addition of language to prevent exemptions for cribs intended for playing. However, we also recommend revision to the proposal exempting certain products from including a mattress.
Read More »FDA Accelerated Approval Pathway: Controversies and Reform
Recent controversies of drugs granted accelerated approval have raised important questions about the evidence needed to determine whether the benefits outweigh the risks in the short-term or the long-term, and what can be done to improve the pathway.
Read More »NCHR addresses proposed changes to acne medicine iPLEDGE program
March 29, 2023: NCHR testimony at an FDA advisory committee recommends changes to the iPLEDGE REMS (risk reduction) program for patients taking the acne medication isotretinoin, which causes birth defects. We recommend eliminating unnecessary barriers for women who are unable to become pregnant and strengthening contraceptive requirements for adolescents.
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