IACP Successful In Restricting FDA Funds
Thursday, September 11, 2014
Posted by: Dagmar Anderson
A major legislative initiative for IACP this year focused on preventing the FDA from receiving and using federal funds to pursue 503A traditional compounders who are practicing within the bounds of their state pharmacy practice acts. Beginning in March, IACP met with and negotiated language to be included in any 2015 budgets or appropriations bills to accomplish that. With time running out before Congress recesses again before the mid-term election, the Academy turned its efforts to making sure that any Continuing Resolution (CR) that might be enacted to keep the government up and running would include similar language. The CR is essentially a budget that tells the Administration "you have this amount of money to continue doing what you're doing plus some additional money to do these very specific things."
Yesterday, that CR was introduced by the House as HJR 124 and will be voted on this week before moving over to the Senate. Included in that CR is Section 117 which IACP successfully lobbied for on your behalf:
For “Department of Health and Human Services—Food and Drug Administration—Salaries and Expenses”, amounts shall be made available by this joint resolution as if “outsourcing facility fees authorized by 21 U.S.C. 379j-62,” were included after “21 U.S.C. 381,” in the second paragraph under such heading in division A of Public Law 113-76.
This means that the only additional funds which the agency may obtain through fees may be used to establish the programs and procedures necessary to manage the newly created registration category for 503B outsourcing facilities. No funds requested by the agency were included to continue the FDA's actions against traditional 503A compounding pharmacists.
Following the release of the President’s budget earlier this year, FDA released its own FY 2015 budget request detailing how the President’s requested funding of $4.7 billion would be used by FDA in 2015. Out of the $2.6 billion requested for medical product safety, FDA would invest $25 million to “enhance compounding oversight activities in FY2015.” Due to the fact that the registration by outsourcing facilities (OFs) -- a new registration type included in the Drug Quality & Security Act -- is not mandatory, FDA protests in its budget request that it cannot rely upon the fees that OFs might provide. In addition, the DQSA specifically states that fees obtained through the registration of OFs may only be used to oversee OFs. Thus, FDA cannot use these funds to oversee compounding pharmacies that do not choose to register with FDA as an OF.
The FDA Office of Regulatory Affairs had requested almost $7 million in additional funding for field activities including “conducting additional inspections of high-risk human drug compounding pharmacies including sterile compounding facilities that seek to qualify for the exemptions under section 503A and facilities that register as OFs under section 503B.”
Upon the passage of the Drug Quality and Security Act, pharmacists were told that office-use would continue to be governed under State laws. Specifically, there are over six Statements on the Record from the House and Senate stating that FDA does not have jurisdiction to prohibit pharmacies from compounding for office-use (compounding medications for the administration within a doctor’s office, hospital, or other health care setting). FDA’s public statements and response to Congress are that they do not believe that “office use” is permitted.
Part of Compounders on Capitol Hill Efforts
The Academy believes it is appropriate to restrict the FDA’s appropriations for 2015 to prevent the agency from taking enforcement action contrary to Congress’ will. IACP seeks only to limit the agency’s implementation of the Drug Quality & Security Act in those areas which are clearly contradictory to how Congress wished the law to be implemented. During the more than 400 visits to the Hill during our June 2014 Compounders on Capitol Hill meeting, IACP members explained how giving the FDA additional funds without restrictions would further enable the agency to ignore clear Congressional direction.
Those conversations with Senators and Representatives helped us retain the negotiated language which had been developed by IACP's lobbying team. While the restrictive language was much more detailed in the original series of appropriations bills, being able to include a modified version in this very streamlined CR is an enormous victory for compounders and our organization.
When Congress returns from the mid-term elections, IACP will continue to monitor and press for budgetary language that keeps the FDA "on its toes" and sends a clear message that Congress is watching them.