Summary
Your voice, experience and advocacy for your pharmacy and your patients is needed on Capitol Hill. If you compound personalized medications for patients in need of hormone replacement therapy, we need you at ACT 2024 to address regulatory threats to patient access with Congressional lawmakers in Washington, D.C.
THIS JUST IN — POTENTIAL THREAT HAS EMERGED
The FDA has announced a proposed plan to issue guidance documents "for immediate implementation" — without any comment period. For 10+ years, the FDA has used guidance documents to shape the regulatory pathway for compounders. This looming threat to participatory governance makes it imperative for industry professionals to mobilize and make their dissent heard. By attending ACT, you have an opportunity to confront this concerning issue head-on with legislators. It's a pivotal moment to amplify our voices, as these policy shifts can significantly impact our industry. Please make it your priority to join us this May.
What’s at stake? Commonly compounded hormones.
The National Academies of Sciences, Engineering and Medicine (NASEM) issued a report in 2020 recommending the most commonly compounded hormones be considered for the FDA’s “difficult to compound list.” It is unlawful to compound ingredients on this listing. FDA is reviewing the report and could move to advance the recommendations at any time. Explain how this proposal impacts your practice and your patients.
Your Participation Is Crucial
Regulatory activity in federal agencies is typically stepped up in an election year. Lawmakers regularly weigh in with the FDA on proposed policies of regulated industries. If lawmakers don’t hear from pharmacies in their home districts, they are far less likely to understand how these proposed policies will directly impact the health and well-being of your patients, nor will they understand that your patients typically represent a part of their constituency. Interacting with your lawmakers in Washington, however, can make a difference.
Help Your Patients Maintain Access to Their Medications
More than 80 lawmakers are recently elected to Congress and most are not familiar with pharmacy compounding, let alone how compounded medicines fill the needs of unique patients. Dozens of Congressional members are serving their first term on the House Energy and Commerce Committee or the Appropriations Committee, which oversee FDA policy and the agency’s funding. These lawmakers need to hear from you so they can make balanced and informed decisions when they interact with the agency.
Accept our invitation and register today for the ACT Conference. We’ll schedule your Congressional appointments and provide a half-day briefing session before you head to Capitol Hill for your meetings.
Why Attend ACT?
Accommodations
Pendry Washington DC – The Wharf
655 Water Street SW
Washington, DC 20024
USA
202.843.1111
Click here to book your online reservation.
PCCA Rate: $350/night
Book before April 15, 2024, to get the discounted rate for your hotel stay. Rooms and rates are based on availability. If you miss the hotel cutoff date, you will need to book your room at another nearby hotel unless there are rooms still available.