Advocacy Council Strike Force takes Capitol Hill by storm – Day 1

Every year, the College Advocacy Council’s (AC) “Strike Force” travels to Washington, D.C. to visit Congress. We coordinate with the Allergy and Asthma Network‘s Capitol Hill day to maximize congressional focus on issues important to members and their patients.

The issues the group discussed included:

  • Efforts by United States Pharmacopeia (USP) and the FDA to impose costly and excessive requirements on A/I physicians who prepare allergen extracts in their offices.
  • Funding for the National Institute of Allergy and Infectious Diseases at the National Institute of Health (NIH).
  • Narrow or skinny managed care organization networks that cherry-pick physicians to exclude those who care for chronic diseases, e.g., difficult to manage asthma or immunodeficiency.

Dr. Blaiss, Dr. Fineman, Dr. Imbeau, Dr. Meadows, and Dr. Sublett
Dr. Imbeau, Dr. Blaiss, Dr. Fineman, Dr. Meadows and Dr. Sublett at the Office of HHS.

This year, AAAAI coordinated their congressional visits to coincide with the College. The entire group met as a show of mutual support and agreed to lobby for these three issues.

The AC leaders made the strategic decision to focus their visits with key policy makers on the compounding issue. Instead of seeking meetings with the offices of the Congress members from the home states of the Strike Force, the group set up meetings with committee staff and Health and Human Services (HHS) officials who are in charge of federal compounding policies and regulations.

So, what happened during day one of our visit?

Robert Aderholt and Dr. Meadows
Rep. Robert Aderholt (R-AL), chair of the House Agriculture Appropriations Subcommittee, and Dr. Meadows.

NIH funding

The day before the Strike Force arrived at Capitol Hill, a bipartisan agreement on federal spending was announced and it included a $2 billion increase in the NIH budget. The Strike Force made a point to thank them for their continued bipartisan support.

Compounding

The Strike Force met with HHS Secretary Tom Price’s principle advisor on FDA policy, and Senate Health, Education, Labor and Pensions (HELP) Committee staff responsible for FDA policy and oversight. They also met with their House counterparts from the Energy and Commerce Committee Health Subcommittee. Although we’ve all heard the reports of unrelenting partisanship in Washington, D.C., the committee staff meetings didn’t reflect this.

The group also met with Rep. Robert Aderholt (R-AL), chair of the House Agriculture Appropriations Subcommittee. While this may seem random, this subcommittee sets the appropriations for the FDA.

All the meetings were important not only because of the information the Strike Force could share, but because of the feedback received. The information presented about the safety and efficacy of in-office preparation of allergy extracts was well-received. Particularly, everyone liked the data from a U.S. military multi-year retrospective analysis on the safety of in-office preparation of allergy extracts.

The group met with several staff and members of Congress who had first-hand experience with immunotherapy. Their personal experiences made them skeptical of the need for more federal regulations around preparing allergy extracts in-office. Sen. Tim Scott (R-SC), a senior member of the Senate HELP and Finance Committees, talked about the care he received growing up from an allergist – even after his family was unable to afford his treatments. This poignant testimonial spoke not only about the value of allergy immunotherapy but also the charity and compassion of an A/I physician. It was a very meaningful moment.

Sen. Scott, Dr. Blaiss, Dr. Imbeau, and Dr. Sublett
Dr. Blaiss, Dr. Sublett, Sen. Tim Scott (R-SC) and Dr. Imbeau.

Finally, in an “only in Washington” experience, the group was heading to their next meeting when they were informed by the Capitol Police that they couldn’t leave the hall they were in. When they asked “why,” they were told Vice President Mike Pence was arriving soon. For security reasons, they couldn’t move. Sure enough, a few minutes later, Pence came walking by with an entourage that included CMS Administrator Seema Verma. The next day we learned that Pence and Verma were headed to a meeting with House leaders to hammer out the final details on the vote to pass the American Health Care Act.

Key takeaways

  1. There is strong, bipartisan support for A/I physicians and ensuring that we can continue to prepare patient-specific allergy extracts in our offices.
  2. We are getting drawn into a larger, more controversial, debate on the safety and efficacy of large compounding pharmacies. And, it seems clear that these large compounding pharmacies are intentionally trying to bring A/I physicians into this debate.
  3. Some physician groups are “fronting” for these large compounding pharmacies. The College needs to be sure that as we work with other physician specialties on the compounding issue, we do not align with these groups.
  4. We’ll continue to work with the FDA and USP to seek a long-term, non-legislative solution.

Rep. Palmer, Dr. Meadows, and Dr. Nsouli
Dr. Meadows, Rep. Gary Palmer (R-AL) and Talal Nsouli, MD, FACAAI

Just prior to traveling to Washington, AC leaders were invited to participate in an allergy-only stakeholder meeting with FDA officials to discuss in-office compounding of allergy extracts. The timing of this invitation and the Strike Force meetings was not coincidental.

The College members who visited Capitol Hill the first day included Michael Blaiss, MD, FACAAI, executive medical director; Stanley Fineman, MD, MBA, FACAAI; Stephen Imbeau, MD, FACAAI, vice chair of the AC; Allen Meadows, MD, FACAAI, chair of the AC; and James Sublett, MD, FACAAI, executive director of advocacy and government affairs of the AC. Seven College members joined the group the next day – Dane McBride, MD, FACAAI; Talal Nsouli, MD, FACAAI, Maeve O’Connor, MD, FACAAI; Erika Gonzalez Reyes, MD, FACAAI; Purvi Parikh, MD; John Seyerle, MD, FACAAI; and James Tracy, MD, FACAAI – some at their own expense. More information on day two next week!

If you have any questions or would like any additional information about the Strike Force meetings, please do not hesitate to contact the AC at AdvocacyCouncil@acaai.org.

James Sublett, MD
Executive Director of Advocacy and Governmental Affairs
Advocacy Council of ACAAI

Allen Meadows, MD
Chair
Advocacy Council of ACAAI

Extracts