June 9, 2017
Update on USP 797 and FDA Activities Related to Compounding of Patient Specific Allergen Vials for Immunotherapy
Specialty leaders representing physicians from the American Academy of Allergy, Asthma & Immunology, American College of Allergy, Asthma & Immunology, American Academy of Otolaryngic Allergy and the American Academy of Otolaryngology – Head and Neck Surgery, along with the American Medical Association, the American Rhinologic Society and the Allergy and Asthma Network—representing patient concerns—have been actively engaged with the United States Pharmacopeia (USP) and the U.S. Food and Drug Administration (FDA) regarding proposed standards and regulations impacting in-office compounding of allergen extract for immunotherapy.
In follow up to a February 2017 Stakeholder Roundtable on Allergen Immunotherapy, a workgroup has been formed including leadership of the USP Compounding Expert Committee, representatives from the specialty societies and USP staff. This group met on Friday, June 2 for an update on the continuing effort to revise Chapter 797. Discussions included appropriate standards for training of compounding personnel and processes for ensuring sterility in the office setting. The specialty societies reiterated that there is insufficient data to indicate that additional safety equipment or procedures are necessary beyond the current Chapter 797 standards. Representatives of USP stressed the importance of not creating an exception for any group that would appear to require insufficient safety standards compared to those applicable to other compounding settings. All groups agreed to continue working together in pursuit of an approach that will allow for practitioners to continue to provide this life-changing and life-saving evidence-based treatment, while following procedures designed to ensure patient safety.
On Tuesday, June 6 the FDA Center on Drug Evaluation and Research (CDER) Office of Compounding hosted a series of listening sessions with seven different healthcare constituencies regarding compounding practices in different settings. Our specialty societies participated in similar sessions held in June 2016, but it is significant to note that the allergy/immunology and otolaryngology specialties were invited to a separate session from other specialties for the first time this year. This allowed the discussion to focus extensively on concerns related to compounding and administration of allergen immunotherapy. Discussion focused on the 2016 FDA Proposed Guidance on Insanitary Conditions, which the FDA regarded as a follow up to previous regulations and not the precursor to a set of sweeping new requirements on physical facilities. The FDA acknowledged that the implications on a practice such as allergen immunotherapy were not taken into account in its development. Specialty leaders urged an approach that would balance the potential for infectious adverse events, which the FDA admits has not been identified as a problem, with the increased threat of anaphylactic reactions possible if source extract products are not controlled for consistency and patient status in the physician's office.
We will continue to work together and to keep our members apprised as compounding rules and standards are considered and developed.
December 29, 2016
FDA 11th-Hour Guidance on Compounding
As we shared with the Trump transition team and with Congress earlier this month, the AAAAI has been watching for an 11th-hour action from the Food and Drug Administration (FDA) regarding compounding. We have been particularly concerned about any further action on the August 2016 draft guidance entitled “Insanitary Conditions in Compounding Pharmacies” that suggested that state boards of pharmacy should enforce extreme standards on physician offices by, inexplicably, applying them equally to physician offices as to commercial compounding manufacturing facilities.
The FDA issued a final guidance yesterday afternoon on compounding, focused on prescription requirements. While the final guidance does specifically include physician in-office compounding, it does not appear to reflect the overreaching approach taken in the “Insanitary Conditions” document. Yesterday’s finalized guidance on prescription requirements acknowledges that compounding in the physician’s office reflects a physician/patient relationship. It requires that the patient’s individual prescription needs to be documented, with the patient’s name, in the patient’s medical record. While we recommend that you review the document for yourself, we are pleased to tell you that we find it encouraging.
We are hopeful that this finalized guidance reflects an appreciation for the importance of our ability to provide safe and effective patient care by preparing allergen extract in our offices. Meanwhile, we will certainly continue to remain vigilant for any additional 11th-hour FDA regulations, but we are pleased to share with you what we see as an encouraging step from the FDA.
You can read the final guidance, Prescription Requirement Under Section 503A of the Federal Food, Drug and Cosmetic Act, here:
December 16, 2016
Urgent Compounding Communications
The AAAAI Board of Directors sent a letter November 25 to the Trump Transition team to share our concerns about the FDA’s recent draft guidance, “Insanitary Conditions in Compounding Facilities.” Read the letter here.
Although Republican leadership has urged federal agencies to not issue any final regulations in the waning days of 2016, there is no guarantee the FDA will not issue a final guidance. On December 2 we shared our letter with members of Congress, along with a reminder of the letter sent by Senator Casey and colleagues to the Department of Health and Human Services, expressing concern about the draft guidance.
November 23, 2016
Transition Team Letter
AAAAI Keeps Compounding Concerns Before the AMA House of Delegates
The AAAAI submitted a resolution to the recent American Medical Association (AMA) House of Delegates Interim Meeting calling attention to the Food and Drug Administration’s (FDA) recent draft guidance, “Insanitary Conditions in Compounding Facilities.” This draft guidance inexplicably included physician in-office compounding in its definition of compounding facilities, which was inconsistent with any previous FDA action. The resolution called for the FDA to withdraw the draft guidance until the United States Pharmacopeia (USP) completes its revision of USP Chapter 797, which provides standards for sterile compounding.
The AAAAI worked with a number of other specialties to build support for the effort, and significant discussion and testimony were shared in Reference Committee. Ultimately, a final resolution was approved that called for FDA to remove physician in-office compounding, and also ambulatory surgery centers, from their definition of compounding facilities, without specific reference to the draft guidance regarding insanitary conditions. We are very pleased with this outcome and send our deepest thanks to the AAAAI’s AMA voting delegate, Steven G. Tolber, MD, FAAAAI, and alternate delegate and previous longtime delegate, George R. Green, MD, FAAAAI.
We also recognize and thank the American College of Allergy, Asthma & Immunology delegate Alnoor A. Malick, MD, FAAAAI, American Academy of Otolaryngic Allergy delegate Wesley D. Vander Ark, MD, and also Kira A. Geraci-Ciardullo, MD, and Stephen A. Imbeau, MD. Finally, we celebrate the outstanding leadership of AMA House of Delegates Chair, Susan R. Bailey, MD, FAAAAI.
The AAAAI continually works to protect and advance patient access to evidence-based care, including allergen immunotherapy. This practice requires a very personalized approach, as each patient’s allergen extracts are mixed individually, and vials of extract may be modified over the course of treatment to adapt for treatment progress, ongoing symptoms, or changes in the patient’s treatment schedule or overall condition. This makes it necessary that allergists and their staff be able to manage these extracts in the physician’s office, both at the start of treatment and sometimes later in the course of treatment.
In September 2015, the United States Pharmacopeia proposed revisions to its General Chapter 797, which outlines standards for pharmaceutical sterile compounding. The current Chapter 797 sets forth varying requirements for sterile compounding based on risk, with a special exception for allergen extracts. The 2015 proposed revision treats all compounding as equally and inherently dangerous, thereby requiring the same procedures for allergen extract compounding as all other compounded materials, despite the significant difference in potential risk between the administration of allergy shots and other kinds of injections. The response to the proposed revisions has been enormous, and consideration of the comments and their implications have pushed the USP’s timeline for updating Chapter 797 beyond 2017.
In August 2016, the FDA issued a draft guidance titled “Insanitary Conditions at Compounding Facilities,” and specifically includes physicians’ offices. The draft guidance describes a set of conditions for which any compounding should be considered insanitary, and those conditions include any environment that does not utilize the kinds of extraordinary and expensive safety protocols previously only required for higher level risk procedures under the existing Chapter 797.
Although an FDA draft guidance is non-binding and does not carry the weight of law, the draft guidance encourages state regulatory agencies to actively enforce these recommendations under their own state laws, thus superseding existing FDA regulation that requires those engaged in compounding activities to follow current requirements set forth under USP Chapter 797.
The AAAAI and others are actively seeking a reversal of the draft guidance.
Insanitary Conditions at Compounding Facilities - September 2016
FDA Comments, Townhall - June 3, 2016
Multi-Organization Comments Re USP Proposal - January 2016
Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application - May 2015
USP Proposed Compounding Requirements History
Update on Proposed Changes to USP Chapter 797
The United States Pharmacopeia (USP) Compounding Expert Committee is meeting next week, with 90 minutes on the agenda set aside for all issues relevant to Chapter 797. The AAAAI, American College of Allergy, Asthma & Immunology and the American Academy of Otolaryngic Allergy will all be attending. It is expected there will be very little time spent on allergy/immunology concerns, although it is anticipated that USP will acknowledge the deluge of feedback received from the allergy/immunology community. We also anticipate the announcement of a stakeholder meeting to be held later in the fall that will focus on allergy/immunology concerns. The AAAAI will continue to keep you informed and work collaboratively with our members and other organizations to influence this very important issue for our specialty.
AAAAI and Others to Attend USP Compounding Expert Committee Meeting
The United States Pharmacopeia (USP) Compounding Expert Committee will meet September 20, and the AAAAI, the American College of Allergy, Asthma & Immunology and the American Academy of Otolaryngic Allergy are all planning to participate. Chapter 797 has 45 minutes on the agenda, during which the timeline, public comments, and stakeholder meetings to follow up on those comments will be discussed. Because the issues resulting from the 797 proposal impact a wide variety of specialties and concerns, we anticipate that allergy will be a fairly small part of this discussion, even though we have heard that we generated the majority of the comments.
We are currently awaiting details on a stakeholder meeting focused on allergy concerns later in the fall. The AAAAI continues to make working on behalf of the specialty in regards to access to allergen immunotherapy, and collaborating with others to do so, a top priority. We will keep you informed through Practice Matters, eNews and additional email updates.
July 21, 2016
Immunotherapy Safety and United States Pharmacopeia (USP) 797 Update
The AAAAI remains committed to advancing the practice of allergen immunotherapy and continues to fight the Chapter 797 changes proposed by the United States Pharmacopeia (USP). As communicated in June Practice Matters, AAAAI and other organizations participated in a June 3 Food and Drug Administration (FDA) listening session on compounding. Advocacy Chair Andrew W. Murphy, MD, FAAAAI, spoke with USP representatives in person at that meeting to reinforce our concerns. Executive Vice President Thomas B. Casale, MD, FAAAAI, Past President Linda Cox, MD, FAAAAI, Board member Aidan A. Long, MD, FAAAAI, and others also spoke with leaders from USP at the Eastern Allergy conference in Palm Beach, Florida on June 4.
The AAAAI recently submitted comments to the FDA in response to proposed rules about compounding in hospital and health system pharmacies. One proposed rule would allow products compounded by such a pharmacy to only be administered within one mile of the facility. We told FDA this threatens access to allergen immunotherapy for patients seen by staff physicians of healthcare systems who practice in community clinics, some of which are in economically depressed areas where pediatric patients receive allergen immunotherapy for allergic asthma. We reiterated that any proposed change to compounding rules must balance perceived safety risks with patient access to proven, safe and effective medical care. See the AAAAI's comments here.
The AAAAI received support from the American College of Physicians (ACP), which also submitted comments to the FDA in support of patient access to care and safety concerns that necessitate allergen extracts prepared via physician in-office compounding. See the ACP's letter here.
Additional postings from the FDA earlier this week will also be commented on, and outreach to members of Congress and other interested organizations continues as well. While it is difficult to estimate when the USP issue will be resolved, we are extremely confident that USP is much more aware and tuned into the concerns of the A/I community related to the proposed Chapter 797 changes.
June 16, 2016
Immunotherapy Safety and United States Pharmacopeia (USP) 797 Update: Comments Presented to FDA and Casey Letter Delivered to HHS
The AAAAI has been constantly working to advance the practice of allergen immunotherapy, especially in light of proposed changes to policies and procedures regarding sterile compounding. Several notable updates include the AAAAI's attendance at a Food and Drug Administration (FDA) listening session on compounding and the delivery of Senator Bob Casey's letter to Department of Health & Human Services (HHS) Secretary Burwell.
AAAAI Presents Comments at FDA Listening Session on Compounding
Advocacy Chair Andrew Murphy, MD, FAAAAI, attended a June 3 FDA listening session on compounding and presented comments on behalf of the AAAAI. Read the comments here.
The AAAAI was informed of the listening session by colleagues at the American College of Physicians, who the AAAAI has been working with on the compounding issue. After securing an invitation, the AAAAI requested that the American College of Allergy, Asthma and Immunology (ACAAI) and American Academy of Otolaryngic Allergy (AAOA) receive invitations as well. All three groups collaborated and coordinated to ensure a consistent message was being delivered while preserving the unique perspective of each organization. While this was strictly a listening session, the AAAAI had the opportunity to continue strategic discussions with the American Medical Association (AMA), Federation of State Medical Boards (FSMB) and USP after the meeting.
Casey Letter Delivered to HHS Secretary Burwell
At the request of the AAAAI, Senator Bob Casey (D-PA) has sent a letter to HHS Secretary Burwell expressing concern about the USP proposal and the extent to which it could "…significantly reduce access to allergen immunotherapy and increase costs, without any evidence that it would prevent infections that, to date, have not been documented in any patients." A total of 13 Senators signed the letter, and these six Democrats and seven Republicans include some very respected and high-ranking Senators. Read the final version of the letter here.
While circulating the letter, we received the attention of a number of Senators who did not sign on but indicated they planned to schedule calls with the FDA or contacts in Secretary Burwell's office to express their concern. The AAAAI's representation in Washington, DC will circle back to these offices.
Thank you to every AAAAI member who took action by calling their Senators and urging them to sign on to the Casey letter. The AAAAI will continue to keep you updated on our efforts to maintain the current USP standards for compounding allergen immunotherapy extracts.
April 29, 2016
The AAAAI is constantly working to advance the practice of allergen immunotherapy, especially in light of proposed changes to policies and procedures regarding sterile compounding.
FSMB Position Statement Will Not Advance; Further Study Likely to Follow
Jennifer Namazy, MD, FAAAAI, presented testimony on behalf of the AAAAI before the Reference Committee of the Federation of State Medical Boards (FSMB) this morning in San Diego, against a proposed position statement that called for an end to in-office physician sterile compounding. She described and distributed the recent Massachusetts General Hospital/Brigham and Women's Hospital study (in press in JACI) showing no infectious events associated with over 130,000 allergy injections provided by two allergy practices to more than 3,000 patients over 10 years. She also provided a compelling description of her patient, a young man who lives on a ranch in California, for whom immunotherapy for a hymenoptera allergy has been a life-changing therapy.
Dr. Namazy's comments were well received and referenced by others who also gave testimony as to the importance of further study so that restrictions on physician compounding would not result in limiting patient access to guideline-based medical treatment. Read Dr. Namazy's comments here.
Dr. Arthur Hengerer, the Chair-elect of the FSMB, informed the Reference Committee that the FSMB Board of Directors had discussed the issue and, after receiving and reviewing input from numerous state medical boards and input sent directly to the FSMB from many in the allergy/immunology community and a variety of other specialties, recommended withdrawing the draft position statement. The FSMB Board recommended that a study of the issue, as proposed in a resolution offered by the North Carolina Medical Board, should be undertaken to identify more appropriate policy for the FSMB regarding physician compounding. The issue will be heard again tomorrow by the FSMB House of Delegates.
The AAAAI thanks Dr. Namazy and everyone who contacted their state medical boards, and will continue to keep you informed as this process continues. Advocacy on behalf of our patients requires that all A/I physicians stand up and voice their opinions. One person alone cannot solve the myriad of challenges that we face. We believe that a stake-holder engaged, transparent process of discussing ramifications on restrictions on physician compounding for evidence-based care will not only result in a more appropriate position for the FSMB, but may also advance our ongoing advocacy with USP to maintain the current USP standards for compounding allergen immunotherapy extracts.
What's Next? Tell Your Senator to Co-Sign Casey Letter to HHS
At the request of the AAAAI, Senator Bob Casey (D-Pa) is sending a letter to U.S. Department of Health & Human Services (HHS) Secretary Burwell expressing concern about the USP proposal and the extent to which it could "…significantly reduce access to allergen immunotherapy and increase costs, without any evidence that it would prevent infections that, to date, have not been documented in any patients." Senator Casey has asked other Senators to co-sign with him. Click here to read Senator Casey's letter and request to other Senators.
Contact your Senators to ask them to co-sign Senator Casey's letter. Contact information for your two Senators can be found here. It is recommended that you call the office of each of your Senators, ask to speak to the staff person who handles health issues, and ask that the Senator co-signs Senator Casey's letter to Secretary Burwell regarding allergy immunotherapy. Talking points to make the case for signing the letter are available here. If the person has not seen Senator Casey's letter, offer to email it to him/her.
If you prefer to send a letter, it should be faxed (NOT mailed) to the Senator's office using the fax number on the Senator's website. Your letter should be faxed to the attention of the "Health Legislative Assistant."
A less effective—but easy—option is to submit your comments via the email/comment link on your Senator's website. Thank you in advance for helping the AAAAI with this next opportunity for engagement.
April 13, 2016
Immunotherapy Safety and United States Pharmacopeia (USP) 797 Update: A New Study, A Survey & Your State Board
The AAAAI is constantly working to advance the practice of allergen immunotherapy. Important updates you need to know include a new study released this week supporting the safety of immunotherapy administration; an invitation to participate in the updated adverse events survey; and an update on communications with state medical boards regarding in-office compounding.
New Study on Immunotherapy Safety
In an article published by The Journal of Allergy and Clinical Immunology (JACI), researchers from Massachusetts General Hospital have confirmed the safety of current allergen immunotherapy (AIT or allergy shots) practices. In more than 130,000 injections given to over 3,000 patients in a 10 year timeframe, no infectious events related to the allergy injections occurred. We are also sharing this new data with USP in follow up to our previous request that current standards for sterile compounding for allergen immunotherapy remain in effect. Read the article here.
Immunotherapy Adverse Events Survey Now Open
The AAAAI has collaboratively supported the Annual Anaphylaxis Survey for 7 years, and worked with David Bernstein, MD, FAAAAI, and others to update this year's survey to include both SCIT and SLIT. In addition, information will be gathered on infection risk from SCIT injections in response to concerns raised by USP. To participate, contact firstname.lastname@example.org for a special code and a link to the survey.
Federation of State Medical Boards Position Statement on In-Office Compounding
The Federation of State Medical Boards (FSMB) is slated to discuss a position statement at their meeting in San Diego at the end of April that discourages any sterile compounding in physicians' offices. Read the position statement here, which begins on page 7. The AAAAI initiated a multi-specialty effort to defeat this position statement, and signed on to a collaborative letter to all state medical boards. The American Medical Association (AMA) then shared information on this effort with all specialty societies seated in the House of Delegates, suggesting their state level organizations contact their state medical boards if impacted by this position statement.
You can still contact your state medical board to reinforce that this position statement interferes with your ability to provide proven effective, disease modifying SCIT to your patients. (Click here for a sample email that you can send to your state medical board.) If you personally know a member of your state medical board, reach out directly to that person. While the AAAAI and others continue to work on your behalf, nothing is as effective as individual contact.
Remember that you can invite your patients to weigh in on the importance of access to allergen immunotherapy from their perspective. Share the Change.org petition in your office, today and every day.
If you missed the AAAAI's panel discussion on USP 797 at the 2016 Annual Meeting, watch it here. It covers USP's proposed changes to the sterile compounding rules, its potential implications on the allergy/immunology specialty and what the AAAAI has done about the issue.
The AAAAI will continue to provide updates in Practice Matters and eNews; and our thanks for the many calls and emails we continue to receive on these important issues.
march 30, 2016
Watch the USP Panel Video from the 2016 AAAAI Annual Meeting.
February 1, 2016
What You Need to Know about Proposed Changes to USP 797
As previously reported to AAAAI members, the practice of allergen immunotherapy as we know it is at risk. The United States Pharmacopeia (USP) has proposed changes to be required of all sterile compounding, including allergen extract preparation.
These changes include more complicated mixing procedures, significantly shortened timeframes for how long extracts can be used, and add burden to your storage and documentation processes. You can read more about the changes in the draft update of USP Chapter 797 available here, which was open for public comment until January 31. Thank you to everyone who submitted comments to USP during this public comment period and to all who shared the AAAAI’s change.org petition to save patient access to allergen immunotherapy. The response from AAAAI members and their patients was extraordinary.
In addition, the AAAAI collaborated with the American College of Allergy, Asthma & Immunology and its Advocacy Council; the American Rhinologic Society; the American Association of Otolaryngic Allergy; the American Academy of Otolaryngology-Head and Neck Surgery; and the Allergy and Asthma Network to develop comments to send to USP.
You can read our letter here.
The AAAAI will continue to keep you updated on the situation as we learn more.
January 27, 2016
USP Update Could Significantly Change In-House Compounding and Patient Access to Immunotherapy
AAAAI Members Urged to Submit Comments to USP by January 31, 2016
As reported in the December issue of Practice Matters and a special Practice Matters alert emailed to AAAAI members yesterday, the practice of allergen immunotherapy as we know it is at risk. The United States Pharmacopeia (USP) has proposed changes to be required of all sterile compounding, including allergen extract preparation. These changes include more complicated mixing procedures, significantly shortened timeframes for how long extracts can be used, and add burden to your storage and documentation processes. These changes are included in a draft update of the USP Chapter 797, which governs sterile compounding, and which is available for public comment until January 31.
This is a critical issue that the AAAAI and ACAAI have been working together to address. If you have not already submitted comments to USP, you are urged to do so by the January 31 deadline. Keep these details in mind:
• The AAAAI's representation in Washington, DC, and a jointly retained consultant have informed us that having members submit personalized comments will be most effective in getting our voice heard. The AAAAI has compiled a variety of information here, which you can use to help put together your personalized comments to USP. The most important information is in all capital letters.
• The section of the USP document linked here that actually shows the changes USP intends to make to Chapter 797 does not have line numbers, despite the fact that USP is asking commenters to reference line numbers. Members should fill out USP's comment submission template linked here as best as they can. You can mention that the Allergen Extracts as CSPS section on pages 17-18 of the USP document is what we want restored and not deleted.
• Members should absolutely communicate with their patients about these proposed USP changes. If the changes are finalized, it will significantly impact patient access to immunotherapy. If you have patients who will personally attest to an improved quality of life thanks to allergen immunotherapy, please invite them to participate in this public comment period as well.
Click here to go directly to the USP site to read the draft update of USP Chapter 797 and download the comment submission template you must use. If you have any questions, contact the AAAAI at email@example.com.
The AAAAI will continue to update you on this situation.