IACP Presidents' Address: A Look Back, and a Look Forward.

IACP President Baylor Rice, RPh, FIACP
A Conversation with IACP President Baylor Rice

Happy Holidays! Happy New Year! As we near the end of 2017, I'd like to take few moments to review the last year with you. I firmly believe we cannot hope to go forward if we don't take time to review and assess the road travelled. When I became your IACP President last December, I wrote you about all the things I wanted to accomplish during my term. 

Looking back at this list - I am so proud on how much we have accomplished, TOGETHER!  One of the best things we did this year was hire new Executive Vice President Cynthia Blankenship, Esq. In her brief tenure as EVP, Cynthia has brought a burst of high-octane energy into our world. Read her Member Initiatives Progress Report and you will get an idea of just how much has been accomplished! After you read these Member Initiatives, you will understand that we are undergoing a dramatic revitalization at IACP. A transformation that is designed specifically for YOU the member. 

This has been an incredibly busy and productive year for the IACP team as we have continued to work with policymakers at every level of government to advocate for your ability to continue serving your patients and your communities as a compounding pharmacist. Our focus in 2017 has continued to be on the FDA's implementation and enforcement of the Drug Quality and Security Act of 2013 (DQSA) and the negative impact the agency's regulatory policies are having on patient access to critical compounded medications. Many of these efforts are coordinated through the DQSA Coalition, a group IACP has led since 2014 and has grown to more than 35 organizations. The DQSA Coalition includes all the major national pharmacy associations, and also many organizations representing prescribers who rely upon compounded medications in the treatment of their patients. Working with this Coalition, we have all worked diligently to preserve patient access to compounded medications.  Saving Patient Access to Life-Saving Compounded Medications is a Patient-Safety Issue!

I'm confident we can keep this incredible momentum going on the Hill and on a state level because your incoming and returning IACP Board of Directors is a very strong one. Our incoming IACP President Erik Tosh, will ensure IACP continues to implement our strategic plan, keeping IACP a powerful resource and ally for our members, and for our pharmacy compounding profession.

It has been an honor serving as your IACP President! I am so proud of all we have accomplished together. Your involvement and support have enabled us to accomplish so much this year! Please continue to support IACP by renewing your memberships, and encouraging your staff and colleagues to join us. Get involved on our committees. Attend the Educational Conference and Compounders on Capitol Hill (CCH)! And, please consider contributing to IACP's One Fund fundraising efforts so that we can keep moving IACP and pharmacy compounding forward, and most importantly, protect your patients' access to the compounded medications upon which they rely!

Thank you, and have wonderful holidays.

Baylor Rice, RPh, FIACP
A Lookback on IACP's Accomplishments in 2017:
  • Engaged and Attended all FDA and Congressional Events Impacting Compounding: IACP has, separately and through the DQSA Coalition, continued to participate in the limited opportunities presented to stakeholders to provide input directly to the FDA on how their current policies on compounding do not match the real world of medical practice or the needs of patients by attending and submitting comments to all Pharmacy Compounding Advisory Committee (PCAC) meetings, FDA listening sessions, Congressional briefings, and the annual Food and Drug Law Institute on DQSA implementation. IACP reports live from all events and makes sure you know the conclusion of votes and opportunities to further weigh-in.
  • Submitted Comments on all FDA Guidance Impacting Compounding: IACP has submitted comments to all FDA guidance documents that impact compounding and circulate these comments to IACP and Coalition members to help assist on additional comments. We have shared these comments with you to ensure you're aware of our activities, and also urge you to harness this content in your own comments to FDA. 
  • Submitted Comments on all Congressional Action Impacting Compounding: IACP also has worked with the DQSA Coalition to submit Questions for the Record during all hearings impacting Compounding including HHS Secretary Confirmation hearings, drug pricing hearings, HHS/FDA budgetary and appropriations hearings, and hearings on Federal oversight of health care. 
  • Obtained Multiple Congressional Letters: Working with the DQSA Coalition and pharmacy champions in Congress, Congress sent multiple letters to FDA stating clearly Congressional intent. More than 60 bipartisan members signed onto these letters sending a clear message to FDA that the issue of patient access to vital compounding medications is not a partisan issue and that Congress never intended to grant FDA the broad overreach of authority that the Agency has taken in the implementation of office-use, the Memorandum of Understanding (MOU), inspections, the PCAC, and in circumventing formal rulemaking.
  • Tracked all State and Federal Actions Impacting Compounding: IACP drastically has expanded tracking of all State and Federal actions impacting compounding in 2017. This year has witnessed a lot of activity at the state level; and we responded with educational outreach to IACP members and with comments to many State Boards of Pharmacy including recent comments submitted to the Boards in California, Washington, Florida, and Massachusetts. IACP also has significantly increased tracking of all Federal activity impacting compounding by monitoring all Congressional hearings, letters, legislation, amendments, and action reporting to you live during hearings and making sure you know what actions Congress are taking. IACP monitors all media and Agency action regarding compounding, making IACP your one-stop shop for all State and Federal regulatory and legislative action impacting compounding! 
  • Increased Grassroots Efforts: IACP heard from members and patients that a patient advocacy website was needed to provide patients with the opportunity to participate in grassroots efforts to preserve their access to vital compounding medications. IACP responded by creating the Partnership for Personalized Prescriptions (P3) which provides education and advocacy efforts, and continues to grow in size and impact as more patients share their testimonials of the positive impact pharmacy compounding has on their lives and lives of their family members and pets. 
  • Introduced Bipartisan Legislation: The major congressional achievement of 2017 for both IACP and the DQSA Coalition was the introduction of HR2871, the Preserving Patient Access to Compounded Medication Act. This bipartisan legislation, introduced by Representative Morgan Griffith (R-VA) and Representative Henry Cuellar (D-TX) now has 40 bipartisan cosponsors in the House, and would clarify key provisions of the DQSA related to 503A office-use compounding, distributions under the Memorandum of Understanding (MOU), FDA inspection authority, require FDA to conduct formal rulemaking pursuant to the Administrative Procedure Act as opposed to guidance documents, and address the vast concerns with the PCAC.  
  • Obtained Appropriations Report Language Regarding Compounding: Working with the Coalition, IACP continues to work with Congress to include Appropriations Report Language directing FDA to revise their current regulatory policies on pharmacy compounding to better align with the statutory language and congressional intent of the DQSA, and to better protect patient access to critical compounded medications.  
  • Conducted a Congressional Briefing: Working with the Coalition, IACP organized and hosted a hugely successful DQSA Congressional staff briefing that attracted more than 50 congressional staffers to learn firsthand from a panel of prescribers and pharmacists the impact that FDA's policies are having upon patient access to compounded medications. 
IACP President-elect Erik Tosh, BS, RPh, FIACP, FACA
Looking Ahead to 2018 with President-elect Erik Tosh

It is a true honor to serve the Academy as your President in 2018. I look forward to continuing the work of  IACP President Baylor Rice , and appreciate all the work he and the Board have done to protect patient access to compounded preparations. IACP has made significant progress toward this with the introduction of HR2871; but, more needs to be done. Our  Executive Vice President Cynthia Blankenship's  leadership will ensure that we continue to move this legislation forward.

On a personal note, I want to thank the IACP staff for their hard work this year, especially during the additional challenge of running the day-to-day business in the midst of a hurricane. Our staff was personally impacted by the storm; but, still kept IACP operational.  We appreciate all the prayers and outreach from members to help our staff during this difficult time.  

One important takeaway was the need for a disaster readiness review afterwards. From that readiness review, we determined that IACP will need to consider infrastructure upgrades as part of our 2018 strategic plan. This is just one aspect of a detailed plan I will be sharing with you early in the new year. For now, I'm thrilled to provide a glimpse into what 2018 holds for IACP, our profession and patients.
2018: A Year of Opportunity.

The IACP team looks forward to continuing our advocacy efforts in 2018 on your behalf, through direct engagement with the Congress, the FDA and the states, both as your professional association and through the DQSA Coalition, and to continuing to build the P3 grassroots network into a powerful and effective education and advocacy tool for the compounding profession. We urge you to get involved and look forward to working with you in the coming year. 
  • We look forward to another active and productive year in 2018 as we work to build support and momentum for HR2871 and to get a companion bill introduced and moving in the Senate.    
  • We are excited that the House Energy and Commerce Committee has announced intentions to hold an oversight hearing of the Health Subcommittee early next year that will focus on DQSA implementation issues. 
  • We also are pleased our request for meeting between FDA Commissioner Gottlieb and the DQSA Coalition has been granted and we are working to get it scheduled in January.  
While many in the pharmacy profession wring their hands over change or see nothing but problems, I am incredibly proud of  our members who serve as vital problem solvers every day, and see opportunity to improve patients' lives ! 

I look forward to serving you this year, and seeing you at  IACP's Educational Conference, January 24-27, 2018 in Ft. Lauderdale, Florida! Please be sure to buy your tickets to IACP's inaugural  President's Gala as we witness the installation of the  IACP Board of Directors Officers. All proceeds from the Gala will go to  IACP's One Fund! Please join us and learn about the many, exciting initiatives IACP has underway for you! Please keep in touch with IACP and  email us whenever you have a question. 

Wishing you and yours a joyful holiday season, and a Happy New Year!

Erik Tosh, BS, RPh, FIACP, FACA
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