Compounders on Capitol Hill (CCH)
A History of Affecting Change
For 19 consecutive years, IACP members have traveled to Washington, D.C., for a legislative conference—Compounders on Capitol Hill. This effort has resulted in tremendous strides over the past 19 years in educating Senators and Representatives about the compounding profession. Compounding has gone from being a little-known practice to having a strong and steady presence in Washington. Compounding pharmacists are now recognized as an important voice and included in important and strategic meetings throughout the capitol as well as at the state level.
More than 515 community pharmacists, pharmacy technicians and pharmacy students either traveled to Washington, D.C., to meet with their federal House and Senate delegations in face-to-face meetings or sent in letters as part of a virtual campaign as part of IACP's Compounders on Capitol Hill this year. “Compounding pharmacists came to Washington to speak with their Senator and Congressional representatives about several specific issues that directly affect their patients,” says IACP President Wade Siefert, RPh. “We are particularly concerned that the new Senate legislation (S.959) as currently written could impede our patients’ access to pharmacy compounding. We are working closely with our respective state representation, and the Senate HELP Committee to resolve issues with the proposed legislation.” IACP continues to educate patients, prescribers, pharmacists, patient advocacy groups, congressional offices, regulatory agencies, state pharmacy associations and state pharmacy boards about the vital importance of continued access to compounded medications.
“These visits to Congress came at a particularly critical time for compounding pharmacies across the country and for the patients whom they serve. Our IACP members are mindful of the terrible tragedy that occurred last year with the New England Compounding Center meningitis outbreak. We never want to see another situation like this, again,” said IACP Executive Vice President & CEO David G. Miller, RPh. “We also believe it’s vital that patients and practitioners continue to have access to compounded medications prepared by licensed pharmacists who are following the necessary guidelines and who are helping patients and practitioners with personalized medication solutions each and every day.”
Among the group traveling to D.C. were 100 first-time participants in the Compounders on Capitol Hill legislative conference. Pharmacists and pharmacist technicians gathered in our nation’s capital from 41 states as well as Ontario, Canada. States represented included: Alabama, Arizona, Arkansas, California, Colorado, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin.
More than 300 community pharmacists and pharmacy technicians from across the United States traveled to Washington, D.C., to meet with their federal House and Senate delegations as part of the International Academy of Compounding Pharmacists (IACP) 2012 Compounders on Capitol Hill 18th annual conference and legislative event held, June 23-26, 2012. In addition to talking to Congress about the importance of having access to personalized medicines, IACP Members specifically addressed the importance of complete Medicare, Medicaid and other prescription insurance coverage for all compounded preparations. “Compounding pharmacists came to Washington to talk with Congressmen and Senators about several specific issues that directly affect their patients,” says IACP President Scott Karolchyk, RPh, FIACP. “We are particularly concerned that Medicare and Medicaid beneficiaries are denied coverage for all compounds due to a statutory ‘glitch’ that requires our members to only use certain forms of medicines to make the personalized prescriptions that those individuals need. For pharmacists, this is an issue of science and professional judgment. For our patients, it’s an issue of affordability.” “IACP is continuing to educate patients, prescribers, pharmacists, patient advocacy groups, congressional offices, state pharmacy associations, state pharmacy boards and Medicaid divisions about the vital importance of continued access to compounded medications. These visits to Congress came at a particularly critical time for compounding pharmacies across the country and for the patients whom they serve. Every pharmacist, pharmacist technician and prescriber who joined us on Capitol Hill this year and those patients and prescribers who have called and written their members of Congress were vital to ensuring that our voices continue to be heard,” says IACP Executive Vice President & CEO David G. Miller, RPh.
The International Academy of Compounding Pharmacists (IACP) held its 17th Annual Meeting & Compounders on Capitol Hill in Washington, D.C. on June 11-14, 2011. Some of our profession’s most active pharmacists gathered in our nation’s Capitol to take the voice of compounding to the Hill! And go to the Hill they did! Perhaps not in recent history have compounding pharmacists had such clear and critical issues to discuss with their legislative contacts – many of whom were newly elected. IACP Member Pharmacists brought four vital issues to their respective state representatives, including: 1) seeking a technical correction to Public Law 111-443 1128H(f)(8) to remove the words, “preparation” and “compounding” for what defines a “manufacturer”; 2) requesting a statutory change to provide coverage for compounded medicines prepared with active pharmaceutical ingredients for all Medicare and Medicaid enrollees; 3) asking Congress to require the FDA to reissue a revised veterinary compounding Compliance Policy Guideline; and 4) seeking a clarification to the DEA’s policy prohibiting dispensing of a controlled substance to a prescriber for the purposes of administering that medicine to a patient. New in 2011 – IACP worked with Washington, D.C.-based Soapbox Consulting, specializing in grassroots advocacy to help schedule Hill appointments and conduct, “Being a Successful State & Federal Advocate” educational sessions.
“Never doubt that a small group of thoughtful, committed citizens can change the world.”
That famous quote from Margaret Mead was in clear evidence during IACP’s 2010 CCH event. IACP Members participated in 238 appointments with Congressmen, Senators and their staff to bring the needs of compounding pharmacists’ front and center to our national representatives. There was no doubt that IACP Members were in Washington, D.C. determined to, indeed, “change the world.”
During those meetings, IACP Members sought to:
- Schedule U.S. Senate oversight hearings into the FDA’s policy on compounding from active pharmaceutical ingredients;
- Demand an explanation of FDA’s regulatory policies on compounding from bulk products that aren’t part of the AMDUCA statute enacted in 1994;
- Ask why the FDA has failed to act on their promise to reconsider the veterinary compounding CPG that was adopted without public review or comment in 2003;
- Revise the language in the physician's "sunshine" provisions of the health care reform bill (Budget Reconciliation H.R. 4872) that mistakenly defines the practice of pharmacy compounding as “manufacturing”;
- Pass an amendment to the Controlled Substances Act to eliminate restrictions on delivering controlled substances for use in intrathecal devices.
IACP’s Annual Meeting & Compounders on Capitol Hill was held in June in Washington, D.C. There were 380 people in attendance from the U.S. and abroad. CCH attendees were well received on Capitol Hill and it was readily apparent the level of familiarity that staff and legislators had with compounding issues. Compounders attended more than 250 meetings with legislators during the conference.
The goal of CCH 2009 was to educate Members of Congress about the many services and patient types served by compounding pharmacists. The focus of the Hill discussions was to demonstrate how compounding is an integral component of contemporary pharmacy practice. IACP used CCH 2009 as an opportunity to build support for compounding and to highlight the role that compounding pharmacies play in the broader health care system.
The 14th IACP Annual Meeting & Compounders on Capitol Hill was a runaway success! More than 340 attendees traveled to Washington, D.C., to object to FDA’s estriol policy and encourage representatives to sign on to the estriol resolution. IACP scheduled 300 appointments for pharmacists and their members of Congress. The results proved positive and productive—a Senate sponsor for our resolution (S. Con. Res. 88) was secured as well as numerous co-sponsors in the House (H. Con. Res. 342). Other successes included Rx Mixer Brings on Heroes & Heroines, which grossed nearly $150,000 for the IACP Foundation’s research and education initiatives. Ninety attendees supported COMP-PAC by attending the second annual PAC luncheon and raising more than $14,000, where the Honorable Steve Symms, former U.S. Senator from Idaho, entertained the audience with his insider perspective of Capitol Hill.
In 2007, IACP hosted its most successful Annual Meeting & Compounders on Capitol Hill in the history of the organization. Not only were there more attendees than ever before—404 to be exact— but the number of companies that exhibited was also a significant jump from previous years, with 30 companies participating. Perhaps the most exciting milestone of the Annual Meeting was the overwhelming success of Compounders on Capitol Hill. Of more than 285 Congressional offices visited, the overwhelming majority indicated that they had heard from patient and prescriber members of Patients and Professionals for Customized Care (P2C2) about the importance of compounding, and many Hill offices commented on the impact of P2C2. IACP hosted an inaugural PAC luncheon, which raised $16,700 to directly benefit IACP’s political action committee. And of course, the IACP Foundation’s Rx Mixer Visits Woodstock was a huge accomplishment in raising money to fund research and education initiatives that benefit the compounding profession.
The 2006 IACP Annual Meeting & Compounders on Capitol Hill was one of our largest meetings with roughly 300 attendees. IACP continued to offer excellent continuing education programming on quality, marketing, public affairs issues and more. The Rx Mixer grossed more than $127,000 for IACP Foundation with more than $15,000 dedicated for immediate funding for research. Pharmacists took to the Hill to talk to their Members of Congress about FDA Citizen Petitions filed by pharmaceutical companies to restrict the availability of BHRT and other compounded medications. Pharmacists circulated a model letter, which numerous Members of Congress sent to FDA to ensure that FDA did not unduly restrict access to compounded medications by supporting the recommendations of the Citizen Petitions.
In 2004, IACP members took to the Hill objecting to FDA’s veterinary compounding CPG. As a result of that meeting, FDA publicly agreed to revise its compounding CPGs. However, June 2005 arrived with no action by the FDA. Thus, at CCH 2005, Compounders visited the Hill highlighting FDA’s failure to fulfill its promises and asking Congress to hold FDA accountable to revising and reissuing the promised CPGs. In total, 82 Congressmen and 26 Senators signed letters that requested FDA to explain to Congress the delay in revising the CPGs and to reissue the CPGs promptly. In addition, 5 Congressmen and Senators sent individual letters bringing our grand total to 113 total supports an unprecedented success! IACP also offered two days of continuing education to over 300 compounding pharmacists, which was a resounding success. Continuing education topics covered quality assurance, testing of compounded medications, legal issues relating to compounding and marketing your practice.
During IACP’s 10th annual meeting, compounders took the fight for animal compounding rights to D.C. Thanks to attendee dedication and persistence, IACP was able to secure support from 48 Representatives and 18 Senators who signed on to our respective House and Senate letters regarding the rescission of FDA’s Veterinary Compliance Policy Guide (CPG). In addition, Senators Corzine (NJ), Cornyn (TX), and Nelson (FL), along with Representatives Boozman (AR-3), Franks (MA-4), and Tiberi (OH-12) sent their own copy of the letter. Continuing education involved updates on accreditation, USP and a visit from Small Business Administration National Ombudsman Michael Barrera.
IACP’s 9th Annual Meeting and Compounders on Capitol Hill was once again a success thanks to all of our dedicated members. More than 120 Congressmen and 80 Senators received the compounding message this year. Because of the amount of attendees, we were able to demonstrate strength in numbers on Capitol Hill to garner support for H.R. 2232, which would clarify application of the 1987 Prescription Drug Marketing Act (PDMA). We had nine legislators agree to co-sponsor this bill before the meeting was even over. IACP once again offered two days of continuing education that included how to avoid pharmacy compounding errors, marketing tips, media training and much more.
Compounding pharmacists once again stormed the Hill in 2002 to garner support for H.R. 68 and S.1132, bills that offered relief from the proposed stringent Prescription Drug Marketing Act regulations. Pharmacists met great success this year, adding more than forty names to the cosponsor list for the bills. IACP once again welcomed representatives from leading pharmacy organizations to offer their insight on how the U.S. Supreme Court’s decision to strike down Section 503A would affect the practice of pharmacy. In addition to offering members access to their elected Representatives, IACP expanded its programming to include invaluable continuing education and offered participants access to vendors dedicated to meeting the needs of compounding pharmacists.
FDA issues a final rule implementing the Prescription Drug Marketing Act (PDMA) that could greatly reduce the number of active ingredients available for compounding pharmacists. More than 230 participants returned to Capitol Hill to secure support for H.R. 68, a bill designed to fix the PDMA regulations. As a result of the Hill visits, 20 new co-sponsors were added to H.R. 68 and a Senate Bill (S.1132) was introduced. In addition, a panel of organizations including USP, FDA, NABP, APhA, ASHP, NCPA, and PhRMA participated in IACP's Professional Connection Luncheon to address the future of regulatory environment for compounding in light of an Appellate Court decision that ruled the compounding section of the FDAMA is unconstitutional.
In March 2000, more than 100 compounding pharmacists convened in Washington, D.C. for IACP’s annual event, Compounders on Capitol Hill, to educate legislators about the issues affecting compounding pharmacists and how a compounding pharmacist promotes the health of patients. One of the issues that IACP pharmacists communicated to legislators was the regulation of Internet pharmacy. Now legislation has been introduced addressing health care in this new arena.
Our education of Congress continued. "Compounders on Capitol Hill" in 1999 discussed the FDA's draft MOU, a particularly troubling example of "overreach" by the FDA. We urged the Senators and Representatives to notify the agency of their concerns with the arbitrary limits on dispensing compounded prescriptions. Within days of our lobbying, a discussion about the draft MOU took place on the Senate floor. Also, numerous Congressional letters were sent to FDA expressing concerns about the draft MOU. At a Senate hearing in October, in response to a question by Senator Tim Hutchinson (R-AR), the FDA Administrator admitted that the FDA had "missed the mark" on the MOU and would be revisiting the issue.
Having been successful in passing the bill, 100 pharmacists met for the 1998 "Compounders on Capitol Hill" to thank their Senators and Representatives for passing the legislation and to ask them to closely monitor FDA's implementation of the law. As a result of these meetings on the Hill, more than 60 Members of Congress sent letters to the FDA regarding the compounding provisions of the law, specifically addressing their concerns about the FDA Pharmacy Compounding Advisory Committee and the Memorandum of Understanding (MOU).
With Representative Brewster's retirement from Congress, compounding pharmacists enlisted Representative Richard Burr (R-NC) and Senator Tim Hutchinson (R-AR) to take the lead on the compounding legislation. Representative Burr introduced compounding legislation (H.R. 1060) in the House. For the first time, IACP gained a vocal supporter in the Senate. Senator Hutchinson was able to add language similar to H.R. 1060 in the broad Senate FDA reform package. With legislation being considered in both the House and Senate, more than 100 "Compounders on Capitol Hill" heeded Representative Burr's challenge that we continue to stand up for our rights and redouble our efforts to educate more Members of Congress. The Washington lobbying efforts, in tandem with the thousands of "grassroots" letters, faxes and phone calls, paid off -- compounding preservation was passed and signed into law as part of the Food and Drug Administration Act of 1997 (FDAMA).
In 1996, we witnessed sweeping FDA reform legislation introduced in the House of Representatives, with Representative Brewster's compounding legislation an important element of the package. More than 100 IACP members attended the second "Compounders on Capitol Hill," encouraging their members of Congress to co-sponsor the Brewster Bill and urging them to pass FDA reform legislation. Because of these meetings, the number of co-sponsors shot up to 141. Although Congress did not pass the legislation in 1996, two years worth of IACP members' efforts with lawmakers had created broad awareness of the compounding issue and laid the ground work for passage in the next Congress.
The Food and Drug Administration (FDA) challenged compounding pharmacists' right to compound prescriptions. As a result, the profession began the process of asking Congress to enact legislation to protect our right to compound. The first ever "Compounders on Capitol Hill" took place in Washington with more than 100 pharmacists, from 30 states, answering this "call to action." Our mission -- educate Members of Congress about our profession and the need for them to co-sponsor legislation to preserve our profession. Representative Bill Brewster (D-OK), a pharmacist, introduced The Pharmacy Compounding Preservation Act (H.R. 598) and by the end of 1995, thanks to the visibility of compounding pharmacists, the bill had attracted more than 70 co-sponsors.