The Alliance Welcomes New Members

This week’s Analysis and Commentary discusses “the iron triangle of deficit reduction,” a term coined by Steven Grossman, and which provides an all-purpose explanation of the ongoing debt limit/debt reduction negotiations and its possible impact on FDA.

Debt Limit Negotiations Continue; No House Appropriations Mark-Up Scheduled Yet. The federal government may breach its borrowing limit on June 1 or soon thereafter. This has precipitated high-stakes negotiations among the House, Senate, and White House. An initial meeting was held this week with no apparent progress. At week’s end, the second negotiating session was postponed from Friday (today) until next week. This week’s Analysis and Commentary and last week’s (here)  go into greater depth about the process and the implications for FDA. 

As part of the larger House Republican strategy, we had expected May/June mark-up dates for the House Appropriations Committee to move FY 24 spending bills. So far, those have been rumored, but nothing has been posted on the Committee site. 

Alliance Webinar on June 5 with FDA Chief of Staff Julie Tierney on FDA Staffing. The Alliance’s webinars on the FDA’s FY 24 budget request had one common theme—FDA staffing issues surrounding vacancies, hiring incentives, recruitment, retention, and training. There was also interest in the “back to campus” policy and the ramp-up cycles for new employees to become proficient. The issues raised by “back to campus” were covered this week in Stat+ (paywall may limit access). 

To provide a comprehensive overview of these issues, Julie Tierney, the FDA’s Chief of Staff, will be the featured speaker on an Alliance webinar scheduled for Monday, June 5, at 1 p.m. Sign up here.

Alliance members are encouraged to submit questions in advance to Steven Grossman so that we can be sure the program is responsive to the information that stakeholders most want to know.

Alliance Webinar on June 20 with Dr. Paul Kluetz, Deputy Director of the Oncology Center of Excellence. Amazing advances are on the horizon for cancer care, such as flash radiation treatments (here). It is 18 months since the Alliance held a webinar on the FDA’s Oncology Center of Excellence (transcript here). 

In a return appearance scheduled for Tuesday, June 20th at 3:30 PM ET, Dr. Paul Kluetz, Deputy Director of the OCE, will update us on the OCE–structure, resources, and advances. To RSVP, please click here and fill out the sign-up form. 

The Alliance Welcomes New Members. The Alliance engages in two primary activities: 1) advocacy for increased appropriated resources for FDA; and 2) education of policymakers, media, and the public about the expanding mission and growing responsibilities of the FDA.

We promote “a well-functioning, well-resourced, and visible FDA that is supported by all stakeholders and maintains the agency’s gold standard.” Stakeholders belonging to the Alliance contribute to advocacy, education, and analysis that provide for a stronger FDA. 

For more information, contact Alliance Executive Director, Steven Grossman. 

Building a List of Alliance Members for Hill Days.  The year’s Hill Days was a success–with more than 40 House meetings and nearly 25 Senate meetings. As the year, and the appropriations process continues,  we will be continuing to meet with House and Senate staff and want to build up a list of Alliance members who would like to participate in future Hill meetings. No commitment is required now; you would be on a list of people that we call first. Let Ben Dash know of your interest.

FDA’s Broad Responsibilities: Hearing Aids and Diagnostics/Antibiotic Resistance. The Alliance likes to point to products that FDA oversees but which might not come immediately to mind. This week, FDA published a new web page with details about over-the-counter (OTC) Hearing Aids: What You Should Know.

The FDA also launched a new webpage to explain how antimicrobial susceptibility test devices are intended to help healthcare providers identify the correct therapy (antimicrobial agent) to treat specific bacterial or fungal infections and help identify drug-resistant infections for patient care.

Both hearing aids and antimicrobial susceptibility testing devices are reviewed and cleared by the FDA’s Center for Devices and Radiological Health (CDRH).