The fight for affordable immunotherapy continues

We’ve been busy lately – stomping out harmful legislation in states, meeting with people in leadership roles to address our concerns in person, and finding out the facts so we know what to do next to ensure affordable immunotherapy for our patients. So what exactly is the latest we’ve been up to?

We’re fighting new, proposed resolutions

The Federation of State Medical Board's (FSMB) House of Delegates Meeting is April 30. They will be considering a resolution with potential implications for compounding in physician offices. The FSMB resolution (statement #4 in this link) calls for physicians to discontinue any practice of sterile compounding done in physician offices. Allen Meadows, MD, Chair of the advocacy council, met with FSMB leadership this weekend; they understand our concerns. It is likely that the resolution will be referred to committee for additional stakeholder input.

We ask that you to contact your state medical society, medical board and their representative to FSMB expressing your concern.

Key points you will want to communicate about immunotherapy and current compounding regulations for allergists include:

  • It’s a proven therapy for asthma, allergic rhinitis, and allergic conjunctivitis.
  • Modifies the immune system and offers the possibility of a cure.
  • Safe preparation for more than 100 years.
  • Sterile extracts are used in compounding.
  • Extracts are considered biologics and should come within the jurisdiction of the Board of Medicine, not the Board of Pharmacy.

Please ask your delegate to support the plan to refer to committee.

Offer the following language to replace their proposed language:

“Sterile preparations of allergen extracts prepared by or under the supervision of specially trained physicians for their individual patients and delivered by subcutaneous injection have a long track record of safety and sterility. We believe physicians that prepare or supervise preparation of allergen extracts for their patients should follow aseptic technique and the protocols developed by the specialty and set forth in applicable published practice parameters.”

You can find the address of your local FSMB by googling Federation of State Medical Board – (insert your state) or by contacting your state medical association.

View the letter the Advocacy Council sent to FSMB.

We’re partnering to help patients

The Advocacy Council has partnered with the Alliance for Patient Access on the topic of respiratory therapy. AfPA is a patient advocacy organization whose members are health care providers focused on policy advocacy. They focus on patient access issues, so patients can get what their doctors prescribe. This partnership can dramatically increase our advocacy footprint. Allen Meadows, MD, FACAAI, chair of the Advocacy Council, was part of the work group who authored a white paper on Improving Access to Respiratory Care, and is quoted in the paper advocating for patient access to affordable immunotherapy. The white paper discusses how the new, possible revisions to USP 797 could have a dramatic effect both on patients and the health care system.

We’re getting the facts

The Advocacy Council has found no evidence the companies from whom allergists purchase allergy products, or who sell SLIT products, are behind this entire compounding issue; in fact, they have been supportive. Reliable sources have indicated to us that these regulations are being promoted by the large compounding companies. These large compounding pharmacies are the companies who were most affected by the Congressional legislation passed two years ago. 

We know you understand efforts such as these are time consuming and expensive. Many of your colleagues realize the graveness of the situation and are supporting the Advocacy Council's efforts through donations to DASH.  Support the defense - for the future of our patients and our specialty. 

Advocacy Issue: 
Extracts