By Amy Shank, PCCA Director of Government Relations

Nearly 50 PCCA members converged in Washington, D.C., on April 9–10 for our seventh annual ACT Legislative Conference on Capitol Hill. In total, these pharmacists met with nearly 100 lawmakers during Congressional appointments to ask for their support of patient access to compounded medications.

Specifically, PCCA members discussed two recent developments related to pharmacy compounding with their lawmakers, and asked for their support: 

• H.R. 1959, the Preserving Patient Access to Compounded Medications Act of 2019, which is bipartisan legislation that Reps. Morgan Griffith, R-VA, and Henry Cuellar, D-TX, reintroduced in the House of Representatives in March 2019
• A letter to the FDA asking that the agency correct the definition of “distribution” in the reissued Memorandum of Understanding so that it does not include patient-specific dispensing. This bipartisan effort is led by Congressman Peter Welch, D-VT, and Congressman Morgan Griffith, R-VA

Rod Harbin of Wellness Pharmacy and PCCA's Lizzie Harbin along with Ginny Isbell of Madison Drugs 
meeting with Rep. Robert Aderholt, R-AL, during PCCA’s ACT Legislative Conference.

H.R. 1959
Reps. Morgan Griffith, R-VA, and Henry Cuellar, D-TX, first introduced The Preserving Patient Access to Compounded Medications Act to the House of Representatives two years ago. However, all legislation not enacted by December 2018 expired, so Reps. Griffith and Cuellar reintroduced this legislation in March as H.R. 1959. It addresses the FDA's implementation of the 2013 Drug Quality and Security Act, which has resulted in limiting and in some cases denying access to compounded medications for many patients and prescribers.

There are four major components of this legislation:

• It allows office-use compounding consistent with state law
• It clarifies that pharmacies dispensing medication pursuant to a patient-specific prescription are not impacted by the Memorandum of Understanding (MOU). As background, the FDA's current draft proposal to implement the MOU includes an overly broad definition of “distribution” that includes the dispensing of medications across state lines. This is important for pharmacies licensed in more than one state. In states that do not enter into an MOU with the FDA, pharmacies could only send 5% of their prescriptions to patients outside their state, which would severely limit patients’ access. Fixing the definitions would alleviate many potential access barriers
• It clarifies that the definition of an “applicable” United States Pharmacopeia or National Formulary monograph includes both drug and dietary supplement monographs. Currently, the FDA is taking the position that only substances with drug monographs may be included as active ingredients in compounded medication for humans
• It clarifies that during the inspection process, the current records exemption applies to all pharmacies, including compounding pharmacies

What You Can Do
We encourage compounders to contact their Representatives’ offices about this legislation. You can read about how to do that under “Contacting Your Representative” below. When you do, consider these suggestions:

• Explain that this bipartisan legislation (H.R. 1959) was recently introduced
• Explain any current patient access barriers you, your prescribers or your patients are experiencing, and why the legislation would help. For example:
  • The FDA's current prohibition of medications compounded for office use is barring access for your prescribers and patients, but H.R. 1959 addresses this
  • The FDA’s current draft proposal to implement the MOU may significantly limit patients’ ability to receive their compounded medications from pharmacies in other states, but this legislation would alleviate this potential access barrier
  • You can no longer include substances with dietary supplement monographs as active ingredients in compounded medications because the FDA only considers drug substance monographs to be “applicable.” The only exceptions to this are substances on the FDA’s “positive list” of ingredients that can be lawfully compounded, or ingredients in Category 1 of the FDA’s interim list of bulk substances for 503A pharmacies (You can read more about that here)
• Ask the staff member if your Representative will cosponsor the legislation, and thank them for researching the proposal
• Mark your calendar, and make a note to follow up with the staffer about 2–3 weeks after your initial conversation to determine if they need more information

We also encourage compounders to contact their U.S. Senators’ offices and ask them to introduce companion legislation to H.R. 1959. You can call the Congressional switchboard at 202.224.3121, ask them to connect you to your Senator’s office, and then ask to speak with your Senator's heath legislative aide.

Rep. Michael Burgess, R-TX, greets conference attendees for their Congressional appointment during PCCA’s ACT Legislative Conference.

Redefining “Distribution” in the MOU
PCCA members taking part in our ACT Legislative Conference also asked their lawmakers to co-sign a bipartisan letter by Congressman Peter Welch, D-VT, and Congressman Morgan Griffith, R-VA, which asks the FDA to correct the definition of “distribution” in its draft MOU so that it does not include patient-specific dispensing. The letter explains that the FDA’s current definition contradicts industry precedent as well as current law.

Under the current MOU proposed by the FDA, all prescriptions that are dispensed would be counted as being distributed. When the time comes for each state to decide if it will sign the MOU, compounding pharmacies may be limited to sending out only 5% of their compounded prescriptions to patients in other states if their state does not sign the MOU, the letter explains. This could significantly impact many patients who need to receive compounded medication from pharmacies in other states.

What You Can Do
This bipartisan letter is open for other lawmakers to sign, and we encourage compounders and patients to contact their members of congress to do so. You can read about how to do that under “Contacting Your Representative” below. When you do, consider these suggestions:

• Ask them to sign the Welch-Griffith letter to the FDA to maintain patient access to the pharmacy of their choice, no matter where they live
• Explain that the FDA’s current definition of “distribution” in the draft MOU is overly broad and would limit patient access if left in the current form

Your Congressional office can contact either Congressman Welch’s office or Congressman Griffith’s office to sign the letter, or for additional information. Please note that the letter is only open for lawmakers to sign, and not for outside organizations or private companies.

Rep. Jaime Herrera Beutler, R-WA, speaks to ACT Legislative Conference attendees at
the legislative breakfast as they prepare to depart for Congressional appointments on Capitol Hill.

Make Your Voice Heard
At our ACT Legislative Conference in Washington, D.C., Rep. Buddy Carter, R-GA, the only pharmacist currently serving in Congress, and Rep. Jaime Herrera Beutler, R-WA, spoke about the state of compounding issues in Congress, and why making the trip to Washington to educate lawmakers matters. We know that the best advocates for pharmacy compounding and patient access to compounded medications are those who have heard from their constituents, either in Washington, D.C., or at a pharmacy visit in their district. 

Whether or not you were able to join us in Washington, and whether or not you are a PCCA member, we still need your help in contacting your Representatives. Please review the information in this blog post and contact your Congressional Representative’s office now.

Contacting Your Representative
If you are not certain who your Representative is in Congress, don’t worry. You can find them here. Once you find your Representative, you can follow these steps:

1. Call the Congressional switchboard at 202.224.3121
2. Ask to speak with your Congressional Representative's office
3. When they connect you, ask for the Representative’s health legislative aide
4. Discuss these issues with that staff member

Once you’ve connected with your lawmaker, also consider inviting them to tour your pharmacy and discuss these issues in person. It makes a lasting impression, and they will be more informed by seeing your practice firsthand. Lawmakers are back home during the August district work period, and they are in the process of building out their summer schedules now.

PCCA members, keep your eye on the Public Affairs page of the Members-Only Website for updates on these and other legislative issues. For additional information, members can call us at 800.331.2498.

Amy Shank, PCCA’s Director of Government Relations, previously served as Vice President of Capitol Hill Consulting Group (CHCG), where she advised pharmacy, pharmaceutical and university clients on federal legislative priorities. Amy also has over 10 years of experience in the United States Senate. She was the Director of Oversight and Investigations for the Senate Health, Education, Labor and Pensions Committee. She was also a senior policy advisor to the Senate HELP Committee. Amy was a senior analyst for the Chairman of the Senate Budget Committee, former Senator Don Nickles, R-OK, and began her legislative career in his Republican Whip Office as a policy advisor.