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American Dental Education Association
Volume 2, No. 53, May 10, 2022
House Shows Bipartisan Support for Amending FDA User Fee Agreements
U.S. House of Representatives’ Energy and Commerce Committee Chair Frank Pallone, Jr. (D-N.J.), Ranking Member Cathy McMorris Rodgers (R-Wash.), Health Subcommittee Chair Anna G. Eshoo (D-Calif.), and Health Subcommittee Ranking Member Brett Guthrie (R-Ky.) introduced the “Food and Drug Amendments of 2022 [ [link removed] ] ” on May 4. This legislative package would reauthorize the U.S. Food and Drug Administration (FDA) user fee agreements.
FDA user fee agreements [ [link removed] ] allow the agency to collect fees from drug manufacturers to fund the new drug approval process. To continue collecting user fees, FDA is required to meet certain performance benchmarks related to the speed of certain activities within the new drug approval review process. Specifically, the legislative package reauthorizes the Prescription Drug User Fee Act, Generic Drug User Fee Act, Biosimilar User Fee Act and Medical Device User Fee Act.
The Health Subcommittee is slated to mark up the bill this week. This is one of the few bills jointly introduced [ [link removed] ] by both the Democratic chairs and the Republican ranking members on the Energy and Commerce Committee.
The newly introduced legislation includes provisions from H.R. 6963 Accelerated Approval Integrity Act of 2022 [ [link removed] ] , which was introduced earlier this year by U.S. Rep. Pallone. This bill requires the accelerated approval of drugs to automatically expire after a certain time period for companies that haven’t met post-market clinical benefit requirements. This would ensure that drugs that receive accelerated approval are providing a proven clinical benefit to patients.
The Accelerated Drug Approval Program allows patients to access innovative new drugs while the manufacturer and FDA conduct additional studies to confirm the product’s clinical benefit. However, a British Medical Journal investigation [ [link removed] ] found that half the drugs approved under accelerated approval never had a confirmatory trial done. Though they were unsuccessful, the pharmaceutical industry fought hard to prevent the inclusion of provisions from H.R. 6963 in the reauthorization of FDA user fee agreements.
White House Announces First Black and First Openly Gay Press Secretary
President Biden has tapped his current principal deputy-press secretary, Karine Jean-Pierre, to serve as Press Secretary upon current Press Secretary Jen Psaki’s upcoming departure. Jean-Pierre, who is of Haitian descent, will be the first Black and openly gay Press Secretary. She has served in her current role as principal deputy-press secretary since the beginning of the Biden administration.
New York Prohibits Withholding Transcripts Because of Student Debt
New York Gov. Kathy Hochul (D) signed legislation [ [link removed] ] that prohibits institutions of higher education from withholding transcripts because a student owes an institution a financial debt. Additionally, institutions are prohibited from charging a higher fee or providing less favorable treatment of a transcript request because a student owes a debt. Institutions guilty of violating the law can be charged a fine of up to $500 per violation, and any person injured by an action that violates the new law may bring an action against the violating institution.
Colorado Senate Passes Dental Therapy and Rural Oral Health Workers Education Legislation
The Colorado Senate recently passed a pair of bills that could have an impact on oral health education and oral health workers in their state.
SB 219 [ [link removed] ] would allow dental therapists to practice in the state. If signed into law, the bill would establish requirements to qualify for licensure, as well as requirements for dental therapists to practice under the supervision of a licensed dentist. The bill would require the first 1,000 hours after licensure to be under the direct supervision of a licensed dentist. After 1,000 hours, a licensed dental therapist would be permitted to practice under indirect supervision pursuant to a written agreement between the dental therapist and the dentist. Currently, at least 13 states [ [link removed] ] permit dental therapists to practice statewide or in a limited capacity.
SB 172 [ [link removed] ] would establish the Colorado Rural Health-care Workforce Initiative to expand the number of health care professionals practicing in rural or frontier counties. Under the bill, institutions of higher education would be authorized to establish and operate a health care professionals rural track within any health care professional education program offered by the institution. Rural tracks would be required to set aside seats for students who express an interest in studying and working in a rural or frontier county, and award scholarships to students in the rural track. In order to receive a scholarship, a student must commit to working as a health care professional in a rural or frontier county for two years after completing education and training.
North Carolina Dental Board Debates Deep Sedation Rules
A proposed rule [ [link removed] Notice of Text with 16Q Rules.pdf ] from the North Carolina State Board of Dental Examiners is stirring a lot of interest among oral health professionals and residents in the state. The rule addresses procedures for specified types of sedation and, if adopted, would require the presence of a sedation specialist who is not performing surgical, dental treatment or any other dental assisting tasks during the sedation procedure.
The proposed rule was introduced after the death [ [link removed] ] of a cardiologist who was under sedation during a tooth implant procedure. Many oral surgeons in the state and the North Carolina Dental Society (NCDS) oppose the rule, citing a low number of fatal incidents involving sedation. Oral surgeons and NCDS have also stated that the rule would lead to higher costs and that the supply of appropriate sedation personnel is not great enough to meet the needs in the state.
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
• HRSA Rural Public [ [link removed] ] Health Workforce Training Network Technical Assistance Program
• 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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