406 Attendees Convene in Washington, D.C. for the 21st Annual Compounders on Capitol Hill
The United Voice of Compounders Is Heard!
A special thanks to all the IACP members who participated either in person at Compounders on Capitol Hill, held, June 6-9, 2015 at the Renaissance Washington DC Downtown Hotel, or via our Virtual Hill Day -- your efforts made a HUGE impact. And a fast one as well. One of our key messages to Senators and Congressmen was that the U.S. Food and Drug Administration (FDA's) interpretation of the 2013 Drug Quality & Security Act (DQSA) appears to ignore Congressional intent. Despite repeated invitations from IACP to speak with our CCH conference attendees, everyone at the FDA was again "unavailable" this year to attend and talk to those most impacted by the agency's activities... and that was noticed by Congress.
“Compounding pharmacists went to Washington to speak with their Senator and Congressional representatives about several issues that directly affect their patients,” says IACP President Dale Coker, RPh, FIACP. “We were particularly interested in discussing the Drug Quality and Security Act (DQSA) with our respective representation to ensure access to pharmacy compounding continues. We also emphasized the need for increased communications between the States and FDA as this legislation continues to go into effect.”
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 occurred at a particularly important time for compounding pharmacies across the country and for the patients whom they serve, says IACP Executive Vice President & CEO David G. Miller, RPh. “We 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. There currently are several issues with DQSA that we believe could detrimentally affect patients’ access to the compounded medications they need. We are working closely with our Hill representation, federal regulatory agencies, and state boards of pharmacy to ensure that DQSA is enacted as it was intended by Congress.”
Read more about IACP’s “Fix DQSA” initiative here.
IACP 2015 CCH Asks
IACP and its legislative team have worked tirelessly for the past several months emphasizing that FDA should be implementing DQSA according to congressional intent. This issue was the primary basis of our CCH 2015 Asks.
Issue #1 Support SB 1406 to Make Technical Corrections and Clarifications to the Drug Quality and Security Act
Issue #2 Hold FDA Accountable for Compliance with Congressional Intent in the Implementation of the Drug Quality & Security Act
Issue #3 FDA's Proposed MOU Will Directly Harm Patient Access to Medications
Issue #4 FDA Attempts to Regulate Veterinary Compounding Without Congressional Authority of the Drug Quality & Security Act for Human Compounding to Veterinary Care
CCH 2015 Media Day Update
On Monday, June 8th during CCH 2015, IACP held a media day featuring: IACP President Dale Coker, RPh, FIACP; IACP President-Elect Gary McCrory, RPh, CCN; Vice President Baylor Rice, RPh, FIACP; Board Member Lisa D. Ashworth, BS, PharmD, RPh along with David G. Miller, RPh/IACP EVP/CEO as spokespersons for the association. The following articles are the result of this media effort.
FDA Week - Compounders Seeking Intervention to Stop Proposed MOU - June 8, 2015
Inside Health Policy - Pharmacists Group: FDA Overreaches In Veterinary Compounding Guide - June 11, 2015 (subscription-based publication - for copyright purposes - IACP cannot provide entire story):
Excerpted quote - IACP lists examples in which FDA allegedly has excessively overreached its regulatory authority:
* The guidance applies language in federal human compounding statute to veterinary compounding without authorization from Congress.
* The document also gives outsourcing facilities the ability to prepare veterinary compounds without authorization from Congress, which created the outsourcing facility category to prepare sterile compounds for human use.
* It requires mandatory participation in an adverse event reporting program by pharmacists.
* The guidance establishes an "unreasonable" 14-day supply limits on the amount of medication which can be compounded in anticipation of receiving a prescription.
* FDA mandates specific labeling requirements for pharmacists which are inconsistent with state law.
* The agency mandates specific wording to be included on a prescription by a veterinarian in contradiction to existing state authority over prescribing.
* The guidance interferes in the professional decision making of veterinarians and pharmacists in the use of bulk ingredients to achieve a desired therapeutic outcome.
Inside Health Policy - "IACP Pushes For Congressional Intervention In Office-Use Compounding," June 15, 2015 (subscription-based publication - for copyright purposes - IACP cannot provide entire story):
Excerpted quote - IACP Executive Vice President and CEO David Miller said at the briefing that FDA arbitrarily defined "inordinate quantity" to mean that no more than 30 percent of units compounded per month may be sent to patients in other states. He also noted that FDA did not define what a "unit" is.
The group said FDA's proposal significantly deviates from congressional intent, and says the MOU's proposed requirements for states are unworkable and unduly burdensome, "effectively preventing many States from executing the proposed MOU."
"As written, the proposed MOU will have a direct and deleterious effect on patient access to compound and the business of pharmacies," said IACP.
Washington Examiner - "Congress Wants More Regs on Custom Pharmaceutical," June 9, 2015
Send a Press Release About Your CCH Participation!
Click here for a CCH press release to send after the event, providing a wrap-up on how many attended, and highlights from the conference.
Senator Vitter Introduces SB 1406 - Saving Access to Compounded Medications for Special Needs Patient Act
U.S. Senator David Vitter (R-La.) has introduced legislation to protect and expand access to life-saving compounded medications. Compounded medications are used to treat patients with unique medical conditions that make them resistant to standard medications, such as pediatric cancer patients. Vitter’s legislation, the Saving Access to Compounded Medications for Special Needs Patients Act, would ensure that patients have access to the custom medications they need.
“Compounded medications often go to the most vulnerable patients, like cancer patients and children with special needs. Our children’s health and safety need to be our very top priority, and Louisiana families shouldn’t have to drive to Texas to get life-saving medications,” Vitter said. “FDA overreach is jeopardizing access to these medications, and my legislation would make sure patients and families can get the medicines they need as quickly as possible.”
Please click here to view Senator Vitter's press release.
The Full Report from CCH 2015
Thank you for joining us at IACP’s 21st Annual Compounders on Capitol Hill, June 6-9, 2015! More than 691 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 the fourth annual Virtual Hill Day. Thank you for playing an active role in working to ensure the continued good health of our profession. The future of your practice, your patients’ continued access to compounded meds, and your compounding profession depend in great part upon your participation at this important annual event. Thank you for going to D.C.!
IACP COMP PAC Dinner
On Monday, June 8th, the IACP COMP PAC Dinner hosted the Honorable Charlie Dent, U.S. House of Representatives (R, PA-15) as the keynote speaker. This exclusive event allowed more than 30 members to have a candid and direct dialogue with the Congressman to talk about the future of health care and compounding as well as the current regulatory and legislative issues facing compounding pharmacies. The night raised $25,000, contributing to our yearly goal of $200,000 and making COMP PAC one of the largest political action committees in pharmacy.
Hill Day 2015 at a Glance
Once again this year, IACP worked with Soapbox Consulting, LLC, a D.C.-based company specializing in grassroots advocacy. Soapbox helped to schedule all of IACP’s Member Pharmacist Hill appointments and also conducted a “Being a Good Advocate for Compounding” session. This interactive session provided techniques to successfully convey our position and message to legislators.
The Stats to Date
Although all the debriefing documents are being summarized by our Washington D.C. team, the initial reports from CCH are impressive.
- 176 attendees representing 37 states participated in our annual Hill Day
- 205 face-to-face meetings of which 37 were with the Senator or Congressman
- Attendees met with almost three-quarters of the Senate and more than a third of the US House
In addition to these scheduled meetings, state delegations also called on additional Congressional representatives while they were on the Hill.
IACP’s David G. Miller, RPh, Executive Vice President, and Cynthia Blankenship, Esq., Vice President of Government Affairs, currently are reviewing all of our Hill Day Participants' congressional meeting evaluations and will publish a comprehensive report of action items in an upcoming edition of Capitol Connections.
Picture Perfect - CCH 2015 Photo Gallery
A complete CCH 2015 photo gallery is now available. Click here to view!
Save the Date for CCH 2016!
Save the Date for CCH 2016! June 11-14, 2016 at the Renaissance Washington DC Downtown Hotel!
Thank you to our Exhibitors and Meeting Sponsors!
We would like to thank the following exhibitors for their commitment to Compounders on Capitol Hill: Accreditation Commission for Health Care (ACHC); AirClean Systems; American College of Apothecaries (ACA); Analytical Research Laboratories (ARL); B&B Pharmaceuticals, Inc.; bioMérieux; Blesstia Pharmaceutical; CSI Specialty Group; DYNALABS; Eagle Analytical Services; EMD Millipore Corporation; EXAKT Technologies, Inc.; Fagron Academy; Fagron, Inc.; Freedom Pharmaceuticals, Inc.; Frier Levitt, LLC; Fuji Health Science, Inc.; Genesis Packaging Technologies; Gensco Laboratories, LLC; Germfree Labs, Inc.; Hardy Diagnostics; Health Engineering Systems; Humco Compounding; ICA Health, LLC; International Journal of Pharmaceutical Compounding (IJPC); International Medical Industries, Inc. (IMI); INTERPHEX; KUNESA LLC; Letco Medical; Mar Cor Purification; MEDISCA; National Community Pharmacists Association (NCPA); Onnit Labs; Ortho Molecular Products, Inc.; PCCA; Pharmacy Law Counsel; Pure Encapsulation; Q.I. Medical, Inc.; Regulatory Compliance Associates Inc.; RxCoop, LLC; RXinsider; Storey Marketing; Stratus Pharmaceuticals Inc.; TeleManager Technologies; Topi-CLICK Topical Dosing Applicators; Topi-Pump; U.S. Pharmacopeial Convention.
We would like to thank the following meeting sponsors for their support of Compounders on Capitol Hill: B&B Pharmaceuticals, Inc. (Meeting Tote Bag); Fagron, Inc. (Meeting Syllabus); Freedom Pharmaceuticals, Inc. (Meeting Brochure, Travel Mugs); Humco Compounding (Education Session); INTERPHEX (Education Session); Letco Medical (Welcome Reception, Business Card Holder); MEDISCA (Meeting T-shirt, (3) Education Sessions, Hotel Door Drop); PCCA (Name Badge Holder, Hotel Room Keys, (2) Education Sessions); and Topi-CLICK Topical Dosing Applicators (IACP President Reception, Conference Notepad/Pen Combo;).
We would like to thank the following individual and pharmacy meeting sponsors for their support of Compounders on Capitol Hill: Judicial Sponsor: David Smith, Wildlife Pharmaceuticals, Inc., Windsor, CO; Contributor Sponsor: Eric Clausen, PharmD, MBA, Golden Gate Pharmacy, San Rafael, CA; Ashley Downing, Owner, Vice President, Downing Labs, LLC, Dallas, TX; Debra Elder, Stark Elder Apothecary, Lenexa, KS; Shawn E. Hodges, PharmD, Innovation Compounding, Inc., Kennesaw GA; George W. Warren, RPh, Bay Pharmacy, Inc., Eustis, FL; Charles W. Wilson, Jr., RPh, Owner, Dunwoody Pharmacy, Dunwoody, GA.
To learn more about the exhibitors and meeting sponsors, click here.