Over the past year, MEDISCA’s legislative efforts lead by Aaron Lopez had a positive impact on our customers and the overall industry. We plan to continue having a strong presence on the legislative side, while staying committed to patient care and meeting the highest quality standards for personalized medication.
Here are some of the highlights of what we have done over the last year:
Continuous Presence on Capitol Hill
Speaking with legislators is the cornerstone for bringing about change in Congress. Our commitment to it has been increasing over the past 18 months. We now have a full-time lobbyist on the ground in DC attending hearings, briefings and making visits not only on MEDISCA’s behalf, but also on behalf of the compounders that we serve. We understand that if we want to see change, we must take an active role in making it happen.
Support of HR 2871
This bill by Congressman Griffith highlights most of the issues that we face as an industry. HR 2871 defines congressional intent and leaves little for the FDA to interpret. MEDISCA has been conducting visits on the Hill throughout the year looking for support and asking for legislators to sign on as supporters. We have been very successful at getting the message across and will continue to push appropriate legislation.
Reign in the FDA
One of the greatest ways to influence the FDA is through the power of the purse strings. As an industry, we have come to rely on the Appropriations process to try to reign in the FDA. This year has been no exception. One of the greatest threats we see is the FDA’s unilateral decision to not include dietary supplements as Bulk Drug Substances allowed to be compounded. This year we have pushed for this to be changed and will continue to do so. Several of the appropriators we have been working with have submitted requests to include language in order to reverse the FDA’s policy.
FDA Congressional Oversight
Since the passage of the DQSA, we have felt that the FDA has made several implementations within the compounding industry without truly assessing and understanding the impact. MEDISCA was part of a strong push for the Energy and Commerce Committee (the regulatory committee that oversees compounding) to have the FDA commissioner respond to questions regarding the FDA’s actions. We were also able to request legislators to ask specific questions to the commissioner in order to highlight errors in judgement.
Constant Pressure on the FDA
MEDISCA has taken an active role in the DQSA Coalition to shape the discussion and policy, helping to preserve a pharmacist’s ability to treat patients. MEDISCA’s commitment to the Coalition remains firm and supports IACP’s efforts in leading the discussion.
503A/B Defense of Pharmacists at the FDA’s Pharmacy Compounding Advisory Committee
The FDA has stacked the deck against our industry by placing members on the Advisory Committee that will follow their lead instead of being able to understand the vital role that compounders play in the care of patients. With the addition of Aaron, we have successfully participated in these meetings, having an impact and changing policy.
503B Access to Bulk Drug Substances
Since the announcement of Outsourcing Facilities, MEDISCA has been hard at work trying to service this new compounding resource. However, there has been recent additions and guidance documents that have threatened access that outsourcing facilities have to Bulk Drug Substances. We have led the efforts for access to APIs and have submitted comments to the FDA outlining the dangers that could come from following this new policy. We also participated in the recent all-day event for outsourcing facilities held by the FDA, providing feedback and input.
Recent pushes from the Administration to add tariffs would affect many products that are used in our industry and have the possibility of pricing several compounded products out of the market. Tariff increases are likely to be placed on products from Europe, Mexico, Canada and China. MEDISCA submitted comments and spent three days at the trade hearings pushing for exclusion of medical products and equipment as they are vital to patients in need. We were successful in getting a reprieve and believe the new tariffs will include a carve-out for our products.
State Access to Compounds
States have been taking a hard look on how to control costs. Taking a page out of the PBM playbook, states have been looking at removing compounds from their formularies. We have been involved with discussions to maintain compounds on the formulary, allowing access for those patients whose only relief come from compounded medication.
Inaugural USP Compounding Conference
MEDISCA was asked to participate in USP’s first inaugural compounding conference. With focus on patient safety, we were able to speak to what steps will be taken to ensure quality of our products and the education we provide.