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American Dental Education Association
Volume 2, No. 61, July 6, 2022
Senate HELP Committee Passes FDA Reauthorization Bill
Last week, the U.S. Senate Health, Education, Labor and Pensions (HELP) Committee passed S. 4348 [ [link removed] ] , “Food and Drug Administration Safety and Landmark Advancements Act of 2022” or the “FDASLA Act of 2022,” which would reauthorize various Food and Drug Administration (FDA) drug and device approval programs.
The FDA negotiates with industries to set the fees for the drug and device approval programs, along with goals for review times. Congress then approves the negotiated agreement through the reauthorization process. The current FDA user fee authorization is set to expire on Sept. 30, 2022. FDA user fee authorizations generally last for five years.
S. 4348 differs in several areas from H.R. 7667 [ [link removed] ] , “Food and Drug Amendments of 2022,” the FDA user fee reauthorization passed by the House in early June. While both bills agree on the accelerated approval review times for both brand and generic drugs, there are differences between the two bills on issues such as clinical trial diversity, baby formula, diagnostic tests, drug imports from Canada and cosmetics review and safety.
The Senate bill is expected to move to the Senate floor prior to the August recess.
House Energy and Commerce Committee Holds Hearing on Public Health Legislation
The U.S. House of Representatives’ Energy and Commerce Committee held a legislative hearing [ [link removed] ] entitled, “Investing in Public Health: Legislation to Support Patients, Workers, and Research.” The hearing focused on 11 bills that address public health concerns and foster continued innovation and biomedical research. Two bills discussed during the hearing are of particular interest to the dental community.
H.R. 5141 [ [link removed] ] , the “Maximizing Outcomes through Better Investments in Lifesaving Equipment for (MOBILE) Health Care Act,” introduced by U.S. Reps. Susie Lee (D-Nev.), Richard Hudson (R-N.C.), Raul Ruiz (D-Calif.) and Jamie Herrera Beutler (R-Wash.), would allow Federally Qualified Health Centers to use New Access Point grants for establishing mobile health units, including dental mobile health units. The grants can also be used for building renovations and acquisition and construction costs to increase access to health care in rural and underserved communities.
Finally, H.R. 7845 [ [link removed] ] , the “NIH Clinical Trial Diversity Act of 2022”, introduced by U.S. Reps. Robin Kelly (D-Ill.), Brian Fitzpatrick (R-Pa.), Tony Cárdenas (D-Calif.), G.K. Butterfield (D-N.C.) and Yvette Clarke (D-N.Y.), would require a sponsor seeking to conduct an National Institutes of Health-funded clinical trial investigating a drug, device or biological product to submit an application. The application must include:
1. Clear and measurable goals for the recruitment and retention of diverse participants based on disease/condition prevalence;
2. Rationale for the goals that specifies how investigators measure diversity in the group of participants;
3. A detailed plan for how the clinical trial will achieve the outlined goals;
4. The sponsor’s plan for implementing, or an explanation of why the sponsor cannot implement, alternative clinical trial follow-up requirements that are less burdensome for trial participants; and
5. The sponsor’s education and training requirements for researchers and other individuals conducting or supporting the clinical trial with respect to diversity and health inequities.
The legislation would also launch a public awareness campaign across federal agencies related to research participation opportunities. The bill authorizes $10 million annually for fiscal year (FY) 2023 through FY 2027.
The 11 bills are expected to move to the House floor before the August recess.
House Advances Labor-HHS Appropriations Bill
The U.S. House of Representatives’ Committee on Appropriations has reported its recommendations for the fiscal year (FY) 2023 spending bill for the Departments of Labor, Health and Human Services, Education and Related Agencies. Programs affecting oral health each received increases over the current FY 2022 funding, but not to the levels we were hoping to see.
In the bill, Oral Health Training Programs receive an increase of $1.5 million to $42.2 million of FY 2023, and the Ryan White AIDS/HIV Program Part F’s Dental Reimbursement Program received $13.8 million, an increase of $412,000 over the FY 2022.
The National Institute of Dental and Craniofacial Research’s funding increased from $501 million to $526 million for its important work.
The next step for the bill will be House floor consideration. The Senate has not set a specific time for consideration of its version of the bill but plans to begin consideration of its appropriations measures after the Congressional 4th of July recess.
Delaware Bill Would Allow Telehealth from Out-of-state Practitioners
Both chambers of the Delaware General Assembly have voted in favor of legislation [ [link removed] ] that would allow out-of-state practitioners to deliver health care services by telehealth and telemedicine. An out-of-state practitioner who wishes to provide services in Delaware through telehealth or telemedicine must obtain an interstate telehealth registration from the state’s Division of Professional Regulation and have a license in good standing from another jurisdiction. Additionally, health care providers would be prevented from delivering health care services by telehealth and telemedicine in the absence of a health care provider-patient relationship. A health care provider-patient relationship can be established either in-person or through telehealth and telemedicine, but it must meet requirements established in the bill. Finally, services can be synchronous or asynchronous, using store-and-forward technology.
The bill will be sent to Delaware Gov. John Carney (D) for consideration.
Maine Implements Expanded Dental Coverage for Adults Enrolled in Medicaid
Nearly 217,000 [ [link removed] ] adults in Maine who are enrolled in Medicaid received access to expanded dental benefits on July 1. The expanded benefits were included as part of the 2022-2023 state budget [ [link removed] ] and will include coverage [ [link removed] Dental July 2022 %281%29.pdf ] of full and partial dentures, preventive services, diagnostic services and restorative services.
Prior to implementation of the new benefits, Maine’s Medicaid program only provided dental coverage for emergencies. The state is implementing the changes under an emergency rule [ [link removed] ] and will soon propose a permanent rule.
ADEA Advocacy in Action
This appears weekly in the ADEA Advocate to summarize and provide direct links to recent advocacy actions taken by ADEA. Please let us know what you think and how we might improve its usefulness.
Issues and Resources
• ADEA memo [ [link removed] ] regarding vaccines at the state level
• ADEA report [ [link removed] ] on teledentistry
• ADEA report [ [link removed] ] on the Impact of the COVID-19 Pandemic on U.S. Dental Schools
• ADEA policy brief [ [link removed] ] regarding overprescription of antibiotics
• For a full list of ADEA memos, briefs and letters click here [ [link removed] ] .
ADEA U.S. Interactive Legislative and Regulatory Tracking Map [ [link removed] ]
Key Federal Issues [ [link removed] ]
Key State Issues [ [link removed] ]
The ADEA Advocate [ [link removed] ] is published weekly. Its purpose is to keep ADEA members abreast of federal and state issues and events of interest to the academic dentistry and the dental and research communities.
©2022
American Dental Education Association
655 K Street, NW, Suite 800
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Tel: 202-289-7201
Website: www.adea.org [ [link removed] ]
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B. Timothy Leeth, CPA
ADEA Chief Advocacy Officer
Bridgette DeHart, J.D.
ADEA Director of Federal Relations and Advocacy
Phillip Mauller, M.P.S.
ADEA Director of State Relations and Advocacy
Brian Robinson
ADEA Program Manager for Advocacy and Government Relations
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