April 29, 2024
The Honorable Mike Johnson
Speaker
U.S. House of Representatives
H-232
U.S. Capitol
Washington, D.C. 20515

The Honorable Hakeem Jeffries
Minority Leader
U.S. House of Representatives
H-204
U.S. Capitol
Washington, D.C. 20515

The Honorable Charles Schumer
Majority Leader
U.S. Senate
S-221
U.S. Capitol
Washington, D.C. 20510
The Honorable Mitch McConnell
Minority Leader
U.S. Senate
S-230
U.S. Capitol
Washington, D.C. 20510

RE: Please prioritize drug shortages in the 118th Congress

Dear Speaker Johnson, Majority Leader Schumer as well as Minority Leaders McConnell andJeffries:

On behalf of the American Association of Oral and Maxillofacial Surgeons (AAOMS), which
represents more 9,000 oral and maxillofacial surgeons (OMSs) in the United States, I urge you
to pass legislation to address the nation’s ongoing drug shortages before the 118th Congress
adjourns.

OMSs are surgically and medically trained dental specialists who treat conditions, defects,injuries and esthetic aspects of the mouth, teeth, jaws, neck and face. After earning a dental
degree from an accredited four-year dental school, OMSs complete a minimum of four years of
hospital-based oral and maxillofacial surgery residency training, which includes rotations insuch areas as general surgery, anesthesia, and clinical research.

As the surgical branch of dentistry – and the bridge to medical colleagues – OMSs provide vital
services that are urgent, emergent and outpatient in nature. Most OMS offices function as small,independent operatories with OMSs who diagnose and treat conditions related to themaxillofacial complex. They provide office-based sedation and anesthesia on a daily basis topatients who would otherwise not tolerate treatment outside a hospital operating room.

OMSs are particularly prone to pharmaceutical shortages given their unique skillset and largely
independent practice status. OMSs need access to pharmacologics but have experienced
shortages of anesthetics, analgesics, antibiotics, antiemetics, emergency medications (e.g.
epinephrine, ephedrine, glycopyrrolate, atropine, adenosine) and saline, just to name a few.
When such medications are unavailable – or available at significantly elevated prices, as is
typical during shortage periods – OMSs cannot offer the same high level of care to patients,
significantly impacting the healthcare system.

As you are aware, drug shortages are due to many factors, including regulatory issues with theFDA, manufacturing delays, production quality concerns, shipping issues (both domestic andinternational), company mergers and lack of profitability to produce. Reduced access to thesevital pharmaceuticals has a significant impact on patient care, as alternative drugs may be more
expensive or produce other untoward side effects.

Despite past congressional action, the number of ongoing and active shortages has reached a
new all-time high. 1 Therefore, Congress needs to prioritize the passage of additional legislativesolutions.

While a number of bills have been introduced in the 118th Congress to address drug shortages,
AAOMS particularly supports the RAPID Reserve Act (S 2510/HR 6802). This bipartisan billseeks to incentivize American-based generic drug manufacturers to increase domestic
production, build reserves for potential health crises, and boost production capacity to prevent
shortages. The bill is endorsed by the American Hospital Association and the American Societyof Health-System Pharmacists, among others.
AAOMS also supports other proposed legislative measures to alleviate or prevent shortages,
including: establishing a comprehensive database to track the entire pharmaceutical supply
chain (S 2364/HR 6992); requiring manufacturers to notify the FDA of heightened demand for
crucial medicines that could lead to shortages (S 2362/HR 3008); implementing
reimbursement models to incentivize the production of generic injectables and extending
expiration dates for life-saving medications (S 2586).
AAOMS also requests consideration of these other potential solutions:••

Require enhanced coordination between the Department of Health and Human
Services and the Department of Justice to increase production quotas and remove
regulations that make it difficult for manufacturers to adapt to market shifts.

Mandate a congressional study on the impact of establishing a nonprofit entity to assist
office-based professionals in securing pharmacologics during shortages, similar toCivica Rx, which is currently serving several hospital systems. Civica Rx identifies drugs
that have been on shortage lists in the past, or that have had substantial price increases
because of the competitive marketplace dynamic and manufactures those drugs tooffset market inadequacies.

1 American Society of Health-System Pharmacists. https://www.ashp.org/drug-shortages/shortage-resources/drug-shortages-statistics?loginreturnUrl=SSOCheckOnly. Accessed April 2024.

Patients should not have to wait any longer for access to life-saving medications and those thatenable providers to deliver optimal care. Please contact Jeanne Tuerk, AAOMS Director ofGovernment Affairs with any questions at 800-822-6637, ext. 4321 or jtuerk@aaoms.org.
Sincerely,

Mark A. Egbert, DDS, FACSAAOMS President