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American Dental Education Association

Volume 2, No. 46, March 15, 2022
Biden Administration Unveils Its Test and Treat Initiative

 

The Biden administration released details on its “,” which President Biden previewed in his State of the Union speech on March 1. Under the initiative, individuals could come into a pharmacy, be tested and if they test positive, be given oral treatment. The administration believes that this “one-stop” shop approach will make it easier for individuals to access care.

 

However, the American Medical Association (AMA) is of the plan, calling it “extremely dangerous,” and noting that without a primary physician’s involvement, the patient faces increased risks from possible drug interactions. AMA also notes the need for a physician’s involvement to manage possible negative drug side effects. The AMA has said that it will work with the Biden administration to address their concerns.

House Chairman Introduces Bill to Strengthen the FDA’s Accelerated Drug Approval Process

 

U.S. Rep. Frank Pallone (D-N.J.), Chairman of the U.S. House of Representative’s Energy and Commerce Committee, introduced that calls for modifications to the Accelerated Approval Program. The Accelerated Approval Program allows patients access to innovative new drugs while the manufacturer and the Food and Drug Administration (FDA) conduct additional studies to confirm the product’s clinical benefit.

 

This bill requires the accelerated approval of drugs to automatically expire after a certain period of time for companies that haven’t met post-market clinical benefit requirements, with exceptions. This would ensure that drugs that receive accelerated approval are providing a proven clinical benefit to patients. The bill would also:

  • Codify requirements for manufacturers to conduct post-approval studies on drugs that receive accelerated approval;
  • Require manufacturers to enter into an agreement with FDA on how their studies will be conducted before the agency can grant accelerated approval, which may include details like enrollment targets, milestones and study design;
  • Allow FDA to require studies to be underway at the time of approval; and
  • Require more frequent updates on post-approval studies, including updates on enrollment targets, milestones and study design.

The impetus for this legislation resulted from a which found that half the drugs approved under accelerated approval never had a confirmatory trial done. The FDA’s controversial accelerated approval of Adulhelm, touted as a treatment for Alzheimer’s, is pointed to as an example of the need for better oversight and enforcement of the regulations.

 

This bill will likely be included in a legislative package that will also include the must-pass reauthorization of the Prescription Drug User Fee Act, which is scheduled to be reauthorized this year.

Licensure Bills Sent to Governors in Multiple States

 

Regular readers of the ADEA Advocate may recall a report on licensure bills that was . All of the bills reported on in that article have now passed both chambers of their respective legislatures and have either been signed into law or will be sent to governors in each state. Summaries of each bill can be found below:

  • In Virginia, would allow the Virginia Board of Dentistry to grant a faculty license to a graduate of a foreign dental school without examination, provided the applicant has been granted a certification letter from the dean or program director of an accredited dental program confirming the applicant has clinical competency and clinical experience that meet the credentialing requirements.
  • In Florida, would require candidates for initial licensure as dentists or dental hygienists to demonstrate clinical skills on a manikin rather than a live patient. Specifically, dentists would be required to perform restorations and demonstrate periodontal skills on a manikin that has typodont teeth as approved by the Commission on Dental Competency Assessments (CDCA). Teeth used for restorations would simulate caries, while those used for periodontal skills would simulate calculus. Dental hygienists would be required to demonstrate clinical skills on a manikin that has typodont teeth with simulated dentition and calculus as approved by CDCA.
  • New Mexico’s was signed into law by Gov. Michelle Lujan Grisham (D). This bill will expand the state’s portability laws for number of professions, including those governed by the state’s Board of Dental Health Care. If signed into law, the bill would require the Board to issue an expedited license, without examination, to a dentist or dental hygienist licensed in another licensing jurisdiction if the applicant holds a license that is current and in good standing. The Board would still be granted some discretion, as it would also be required to determine by rule which jurisdictions and foreign countries it will not accept licensed applicants for expedited state licensure. A list of approved and unapproved jurisdictions would be required to be posted on the Board’s website, along with a reason for the disapproval.
Utah Bill Would Allow License by Credentials for Those Licensed Outside of the United States

 

The Utah State Legislature will soon to Gov. Spencer Cox (R) that would allow the state’s Division of Occupation and Professional Licensing (DOPL) to grant a license by credentials to an individual who holds a license that was granted outside of a jurisdiction located in the United States. The bill has passed both chambers of the legislature and if signed into law would allow DOPL to grant a license to anyone who has held a license issued by a jurisdiction outside of the United States if:

  • The person was educated in or obtained relevant experience in a state, district or territory of the United States, or a jurisdiction outside of the United States; and
  • The division determines that the education or experience was substantially similar to the current education or experience requirements for licensure in this state.

The bill also relaxes requirements for individuals who hold a license from other jurisdictions within the United States, as DOPL would be permitted to issue a license:

  • To a person who has at least one year of experience in the jurisdiction where the license was issued, and the division determines the person's education, experience and skills demonstrate competency in the occupation or profession for which the person seeks licensure; or
  • When the division determines that the licensure requirements of the jurisdiction at the time the license was issued were substantially similar to the current licensure requirements of Utah.

While Utah that required DOPL to issue a license to anyone who has held a license granted by another U.S. jurisdiction that is in good standing for at least one year, the state’s still contains language that places additional requirements on dentists and dental hygienists. In addition to meeting the one-year and good standing requirements, individuals applying for reciprocity as dentists must also “document having been successfully engaged in clinical practice as a dentist for not less than 6,000 hours in the five years immediately preceding the date of application for licensure.” Individuals applying for reciprocity as dental hygienists must “document having been successfully engaged in practice as a dental hygienist for not less than 2,000 hours in the two years immediately preceding the date of application for licensure.”
ADEA 2022 VIRTUAL CAPITOL HILL DAY

 

Join us for our 2022 ADEA Virtual Hill Day on April 20 to express your support for the following issues:

  • Protect Funding for the National Institutes of Health (NIH).
  • Preserve Title VII Oral Health Training Programs.
  • Promote across-the-board student loan forgiveness.

Due to the coronavirus, congressional offices are currently closed to the public, but that does not mean you cannot connect with your representatives and senators. Virtually connect with Members of Congress to let them know why protecting funding for NIH, preserving Title VII Oral Health Training Programs and promoting across-the-board student loan forgiveness are important to you. Let your voice be heard!

 

Register by Friday, April 8.
ADEA Advocate will be in Philadelphia next week for Annual Session

 

The ADEA Advocate will be at the . Look us up for an in-person update, see you there! We will resume our normal publication schedule on March 29.

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

  • Provider Relief Fund Reporting
  • HRSA Dental Faculty Loan Repayment
  • ADEA regarding vaccines at the state level
  • ADEA on teledentistry
  • ADEA on the Impact of the COVID-19 Pandemic on U.S. Dental Schools
  • ADEA policy regarding overprescription of antibiotics
  • For a full list of ADEA memos, briefs and letters click .

 

The 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.

 

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American Dental Education Association

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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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