US Federal 2023-2024 Regular Session

US Federal House Bill HB1375

Introduced
3/3/23  
Refer
3/3/23  

Caption

EFFECTIVE Act Ensuring the FDA Fully Examines Clinical Trial Impact and Vitalness before Endorsement Act

Impact

The introduction of HB1375 reflects a growing concern regarding the opioid crisis and aims to enhance scrutiny in drug approvals, especially for opioids that have been linked to severe health risks. Proponents of the bill argue that by requiring a demonstration of significant advantages, it will reduce the likelihood of ineffective or more harmful drugs making it through the approval process. This shift is intended to foster a safer pharmaceutical landscape, particularly in the context of pain management solutions in healthcare.

Summary

House Bill 1375, also known as the EFFECTIVE Act, seeks to amend the Federal Food, Drug, and Cosmetic Act, particularly concerning the approval process for new opioid analgesics. The bill proposes that the Secretary of Health and Human Services would have the authority to deny a new drug application if the drug does not demonstrate clinical superiority over existing medications. This measure is aimed at ensuring that any new opioids offered to the market provide clear benefits in safety and effectiveness compared to currently available options.

Contention

While proponents support the bill for its potential to enhance patient safety, critics may argue that it could unnecessarily prolong the approval process for new drugs that might serve essential needs in pain management. Some stakeholders in the pharmaceutical industry may express concerns about the burden placed on drug developers, believing that stricter requirements could stifle innovation and limit patient access to new treatment options. Thus, the balance between patient safety and the need for accessible pain management solutions may become a point of contention in discussions surrounding the bill.

Companion Bills

US SB607

Same As EFFECTIVE Act Ensuring the FDA Fully Examines Clinical Trial Impact and Vitalness before Endorsement Act

Previously Filed As

US HB6867

NIH Clinical Trial Integrity Act

US HB3521

Clinical Trial Modernization Act

US HB49

Require Evaluation before Implementing Executive Wishlists Act of 2023 or the REVIEW Act of 2023 This bill prohibits a final agency rule from taking effect until (1) the agency submits the rule to the Office of Information and Regulatory Affairs (OIRA), and (2) OIRA makes a determination as to whether the rule is a high-impact rule that may impose an annual cost on the economy of at least $1 billion. In addition, an agency must postpone the effective date of a high-impact rule until the final disposition of all actions seeking judicial review of the rule.

US HB66

Native American Education Opportunity Act This bill addresses education savings account programs and charter schools for tribal students. Specifically, the bill requires the Department of Education and the Department of the Interior, at the request of federally recognized Indian tribes, to provide funds to tribes for tribal-based education savings account programs. Tribes must use these funds to award grants to education savings accounts for students who (1) attended or will be eligible to attend a school operated by the Bureau of Indian Education (BIE); or (2) will not be attending a school operated by the BIE, receiving an education savings account from another tribe, or attending public elementary or secondary school while participating in the program. Funds may be used for items and activities such as costs of attendance at private schools, private tutoring and online learning programs, textbooks, educational software, or examination fees. The Government Accountability Office must review the implementation of these education savings account programs, including any factors impacting increased participation in such programs. Additionally, the bill authorizes the BIE to approve and fund charter schools at any school that it operates or funds.

US HB228

Veterans Affairs Transfer of Information and Sharing of Disability Examination Procedures With DOD Doctors Act This bill addresses the sharing of medical information and disability examination procedures between the Departments of Defense (DOD) and Veterans Affairs (VA). It requires that if a member of the Armed Forces who is required to receive a physical examination upon separation from active duty has or is believed to have a medical condition that may make the member eligible for veterans' disability compensation and benefits, the examination must be performed by a VA-certified health care provider. If the condition is discovered during the physical examination and the examining health care provider is not VA-certified, the examination must be completed by a VA-certified provider. An eligibility determination made as part of such an examination shall be binding on the VA and be used as the basis for assigning the member's disability rating. The VA and DOD shall jointly establish a system to share data and maintain the medical and personnel records of Armed Forces members and veterans.

US AJR117

Designates third full week of May of each year as "Clinical Trials Awareness Week" and May 20 of each year as "Clinical Trials Volunteers Appreciation Day" in NJ.

US SB1230

Marijuana; clinical research trials

US SB778

Clinical Research Pharmacies and Clinical Trials - Permits and Ownership

US SB3564

NIH Clinical Trial Integrity Act

US HB189

Action Versus No Action Act This bill limits the scope of certain environmental assessments or impact statements related to forest management activities on National Forest System lands or public lands suitable for timber production to a consideration only of the effects of the forest management activity and the alternative of no action. Specifically, the bill applies to assessments or impact statements prepared by the Department of Agriculture (USDA), with respect to National Forest System lands, or the Department of the Interior, with respect to public lands, for forest management activities that meet at least one of the criteria specified. In the case of the alternative of no action, USDA or Interior shall consider whether to evaluate the effect of no action on, among other things, forest health, wildfire potential, insect and disease potential, and timber production; and the implications of a resulting decline in forest health, loss of habitat diversity, wildfire, or insect or disease infestation on potential losses of life and property, domestic water supply in the project area, and wildlife habitat loss.

Similar Bills

No similar bills found.