Oxygen

ATS Virtual Hill Day on Access to Supplemental Oxygen – Seeking Volunteers

Want to reach out to Congress from the comfort of your own home (or office)? Sign up to participate in the ATS Supplemental Oxygen Access Virtual Hill Week!

The ATS is excited to announce the ATS SOAR Act Virtual Hill Day at the end of July. The event provides an opportunity for us to collectively advocate for critical legislative changes that will benefit Medicare beneficiaries requiring supplemental oxygen.

As background, the Medicare competitive bidding program for durable medical equipment has decimated the supplemental oxygen market. Patients in many areas of the U.S. are unable to access the full range of oxygen equipment, including liquid oxygen, and are forced to use the least expensive oxygen system. Further, competitive bidding has severely limited patient access to respiratory therapists to help with their supplemental oxygen treatment. 

Sens. Bill Cassidy (R-LA), Mark R. Warner (D-VA), and Amy Klobuchar (D-MN) introduced legislation aimed at reforming the Medicare supplemental oxygen benefit to ensure that beneficiaries have access to this effective and essential medical treatment. Companion legislation has been introduced in the House of Representatives by Rep. David Valadao (R-CA), Rep. Julia Brownley (D-CA), Rep. Larry Bucshon (R-IN), and Rep. Adrian Smith (R-NE).

The ATS is organizing a virtual Hill Week – the week of July 22, 2024 – to schedule virtual meetings with Congressional offices to urge them to cosponsor the Supplemental Oxygen Access Reform Act (S.3821/H.R. 7829). This is a pivotal moment to make our voices heard and to support the passage of this important legislation.

We hope you will join this advocacy effort. Register here!

TOBACCO CONTROL

Senate Hearing Puts FDA in the Hot Seat on E-Cigarette Regulations

The Senate Judiciary Committee held a hearing this week to provide oversight of the FDA’s regulation of illegal e-cigarette products. At the hearing, concern was expressed on a bipartisan basis that the FDA was significantly failing to provide any meaningful regulation of the e-cigarette market – effectively putting the health and welfare of U.S. youth at risk. 

Brian King, PhD, director, FDA Center for Tobacco Products, was joined by Arun Rao, deputy assistant attorney general, Consumer Protection, Department of Justice, in testifying on behalf of the Administration. Both witnesses conceded to the need for the federal government to improve efforts to protect youth and crack down on illegal e-cigarette manufacturers and distributors. In defending federal efforts, Dr. King noted that the FDA and the DOJ have recently taken significant steps against illegal e-cigarette makers including warning letters, citation, civil fines and seizure of illegal e-cigarette products. Both Dr. King and Mr. Rao made pointed comments that if Congress were to provide more resources, the FDA and DOJ could more effectively regulate the e-cigarette market.

FDA and DOJ Announce New E-Cigarette Enforcement Effort
In related news, the FDA and the Department of Justice announced earlier this week a multi-agency effort to “combat the illegal distribution and sales of e-cigarettes.” The FDA has approved 23 tobacco-flavored e-cigarette products. To date, the FDA has not approved any flavored e-cigarette products, making the entire flavored e-cigarettes market illegal. 

The multi-agency effort against illegal e-cigarette sales includes the FDA, DOJ, U.S. Postal Inspection Service, Federal Trade Commission, U.S. Marshal Service, and the Bureau of Alcohol, Tobacco, Firearms and Explosives. As outlined in the press release, the multi-agency taskforce will “focus on several topics, including investigating and prosecuting new criminal, civil, seizure and forfeiture actions under the PACT Act; the Federal Food, Drug, and Cosmetic Act (FDCA), as amended by the Family Smoking Prevention and Tobacco Control Act (TCA); and other authorities.

“Violations of these statutes can result in felony convictions and significant criminal fines and civil monetary penalties.”

Hasmeena Kathuria, MD, chair, ATS Tobacco Action Committee, commented on the announcement: “The ATS applauds the creation of the multi-agency taskforce to crackdown on the distribution and sale of illegal e-cigarette products. It is clear, the e-cigarette industry is intentionally, and unfortunately, effectively going after our nation’s youth. It is well past time for the federal government to take action to protect our nation’s youth and remove these illegal products from the market as quickly as possible.” 

ATS Seeks Regulatory Clarity from FDA on Nicotine Analogue Products
In May, the ATS sent a letter to the FDA Commissioner, Robert Calif, MD, and FDA Center for Tobacco Products Director, Brian King, PhD, seeking clarification on whether novel nicotine analogue products fall under the FDA’s authority to regulate tobacco products.

Nicotine analogue molecules are chemically similar to nicotine but are chemically unique from nicotine created by tobacco plants or synthetic nicotine.  Spree Bar is currently selling e-cigarette products in the U.S. that use 6-methyl-nicotine – a nicotine analogue – as the active ingredient in their product. Initial research has shown that methyl-6-nicotine is more addictive and more toxic than nicotine. Spree Bar products are sold in a variety of kid-friendly flavors such as “Blue Razz Ice”, “Strawberry Apple Melon,” and “Strawberry Mango.”

While the agency has not yet formally responded to the ATS letter, senior level staff at the FDA have confirmed that the agency currently does not have the authority to regulate nicotine analogue products as tobacco products. It remains to be seen if the FDA will use its authority over drugs to regulate nicotine analogues.

RESEARCH

ATS Comments on NIAID Strategic Plan

The ATS recently submitted comments in response to the National Institute of Allergy and Infectious Diseases (NIAID) call for public input on their draft of their five-year Strategic Plan. The call for public input sought comments on several NIAID research priorities, including:

Priority 1: Advance foundational research on the immune system, host-pathogen interactions, and pathogen biology.

Priority 2: Apply foundational knowledge of the complex interactions between microbes and the immune system to develop and test medical countermeasures against known infectious diseases (non-HIV/AIDS).

Priority 3: Apply knowledge of HIV/AIDS to reduce HIV incidence through the development of safe and effective prevention, treatment, and cure strategies.

Priority 4: Apply knowledge of basic immunology to develop and enhance intervention strategies for asthma, allergic and immune-mediated diseases, and transplantation.

Priority 5: Support innovative research efforts to prepare for and respond to nationally or internationally significant biological incidents affecting public health.

The ATS’s comments addressed tissue lung transplantation and chronic lung allograft dysfunction and the need for research to: (1) better understand the recipient- and donor-driven risk factors and fundamental mechanisms of CLAD in both adult and pediatric cases, and (2) identify minimally-invasive biomarkers to monitor subject-specific risk for CLAD. The ATS comments also described “…the substantial and significant disparities in the risks for and role of allergic and infectious disease, across numerous populations including those that are recognized minorities.”

BUDGET