Society Advocates for Access to Diabetes and Obesity Medications; Meets with FDA to Discuss Current Prescription Drug Shortages
Over the past several months, the Endocrine Society has advocated for improving access to diabetes and obesity medications amid ongoing drug shortages that have impacted the country.
The Society has heard from our members that they are experiencing limited availability of Ozempic, a GLP-1 agonist used to treat type 2 diabetes, and Wegovy, a GLP-1 used to treat obesity. In May, the Society held two meetings with the Food and Drug Administration (FDA) to discuss the ongoing shortages. We met with FDA Commissioner Robert Califf and the FDA’s Chief Medical Office to learn more about what they are doing to address this crisis. During our meetings, we pressed the FDA to provide more communication to the Society on when shortages occur and what regions of the country are being impacted.
While the FDA has reported that the Ozempic shortage has been resolved, it acknowledged there can be lag periods after a shortage ends. There also have been some limited shortages of insulin reported in recent months and we discussed this with the FDA. In addition, we have had conversations about GLP-1 shortages with Eli Lilly & Company and have reached out to Novo Nordisk about this issue.
If you are currently experiencing a shortage of GLP-1 medication, please contact: [email protected].
NIH Announces Changes Consistent with Endocrine Society Recommendations to Simplify Fellowship and Grant Applications, Peer Review Process
The National Institutes of Health (NIH) has announced changes to fellowship applications and review process as part of a more comprehensive set of updates to grant application and review that will go into effect on January 25, 2025. These changes are intended to reduce administrative burden and facilitate the identification of highly qualified candidates that may be excluded through the current application and review processes through more focused criteria and reduced sponsor and institutional bias.
The new application process refines the original five scored criteria to three scored criteria: a) Candidate’s goals, preparedness and potential; b) Research training plan; and c) Commitment to candidate. A candidate will be evaluated through four personal statements on their potential to benefit from the fellowship based on factors such as their preparedness, training stage, and opportunities available for their training. Importantly, a candidate’s grades will no longer be required or allowed for applications.
The Endocrine Society submitted recommendations to the NIH as they developed the revised framework for grant and fellowship applications, and we welcomed the simplified review framework and efforts to reduce implicit bias in review.
The research training plan will emphasize the development of professional and scientific goals, the role of the mentor and research project, and showcase any resources that are available to support the training program. The commitment to candidate selection will require the sponsor and any co-sponsors to submit five personal statements focusing on the role of the research mentor and mentoring plan to support the candidate’s research training plan and career goals.
National Service Research Award (NRSA) Training Program applications will also undergo changes for applications due on or after January 25, 2025. Training and outcomes will be emphasized and reflected in the overall score. Under the new process, applicants will be asked to refine expectations for the training of mentors and to clarify positive outcomes related to preparing trainees for research and related careers. Additionally, Responsible Conduct of Research and Recruitment Plan to Enhance Diversity will now factor into the overall scoring of an application. Lastly, NRSA Data Tables will be updated to reduce applicant and reviewer burden. The full description of changes can be reviewed in the NIH Grants Guide, noting that additional details are forthcoming.
Broader application and review changes are planned to take effect on January 25, 2025, including the new simplified review framework for most NIH grant applications. Instructions for reference letters will be updated this fall to provide more structure that will allow reviewers to better evaluate applicants applying for F and K awards. The NIH will introduce the requirement to use the new “FORMS-I” application package for grants, which encapsulates the new changes to fellowship and grant applications, the adoption of the Biographical Sketch Common Form, and the Current and Pending (Other) Support Common Form to standardize information gathering across federal agencies and comply with policies related to national security.
The Endocrine Society submitted recommendations to the NIH as they developed the revised framework for grant and fellowship applications, and we welcomed the simplified review framework and efforts to reduce implicit bias in review. We will be on the lookout for additional guide notices related to these changes and share updates in future Endocrine News articles.
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