Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary
Compounding Law; Health Care; Awareness of all Types of Compounding Issues;
Pharmacy Benefit Managers (PBMs), Outsourcing Facilities
Food and Drug Administration and Compliance Issues
Remarks for the 50 State Intergovernmental Meeting to Discuss Pharmacy Compounding--September 26, 2017
Remarks of Anna Abram Deputy Commissioner for Policy, Planning, Legislation, and Analysis U.S. Food and Drug Administration 50 State Intergovernmental Meeting to Discuss Pharmacy Compounding Silver Spring, MD
September 26, 2017
Good morning and welcome. I am Anna Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis here at the Food and Drug Administration.
I would like to thank you all for traveling to be with us today to participate in our sixth intergovernmental meeting on drug compounding. Your partnership is essential as we work together to improve the quality of compounded drug products. The coordination between states and the FDA is critical to ensuring strong oversight of compounding in this country. We greatly value our collaborative work with you under our shared commitment to public health.
Protecting the health of patients who receive compounded medicines remains a high priority for FDA. It is also personally important to me having worked to develop and pass the Drug Quality and Security Act during my tenure working for the United States Senate. It was a privilege to participate in that process, which was directly informed by tragic events that adversely impacted patients, but spurred Congress to come together to enact bipartisan legislation that put in place a compounding framework with new safeguards for patients. It is a privilege to serve at FDA and be part of an Agency charged with protecting and promoting the public health—a mission that encompasses all that we do, including implementing the compounding provisions of the Drug Quality and Security Act.
We are working hard to implement this law, which set forth a risk-based framework to meet patients’ needs for compounded drugs by traditional pharmacy compounders and outsourcing facilities when these needs are not being met by FDA-approved drugs. Oversight remains essential, because compounded drugs, while important to patients who need them, pose ongoing and serious risks. Every year, 2017 included, FDA receives adverse event reports linking patient illnesses and deaths to compounded drugs. These harms may be caused by contamination in drugs that need to be sterile because they are entering the bloodstream, the eye, or the spine. They may also be due to drugs that are superpotent. In 2016, for example, three infants received a compounded morphine sulfate preparation at a strength 20-fold greater than that indicated on the prepared label. One infant had to be taken by helicopter to a nearby children’s hospital. Patients and their caregivers often face substantial, daunting challenges in managing the illnesses that they and their loved ones face. Patients, and the parents of our nation’s youngest patients, expect the medicines they take to work.
Because many patients have legitimate needs for compounded drugs, we must work to reduce the risks associated with them. As we develop our policy and oversight program, FDA continually strives to strike a balance between preserving access to compounded drugs for patients who have a medical need for them while protecting patients from the risks associated with compounded drugs that are not made in accordance with applicable quality standards or other requirements.
We must also target our oversight activities to achieve the greatest public health benefit with the resources available to us. Both FDA and the states have limited resources, so it is important we use them wisely. There are pharmacies across the U.S. and the amount of compounding they do varies widely, from “mom and pop” pharmacies that only compound drugs for patients in their local communities to much larger pharmacies that ship compounded drugs nationwide, operating like conventional drug manufacturers. To maximize the public health protection from our combined efforts and resources, we need to work collaboratively to identify the vast majority of community pharmacies that will be, and should be, overseen primarily by the states, and the small minority of much larger pharmacies that are currently being overseen by the states, but should be overseen by FDA because of the higher risk nature of the activities they are engaged in.
With this information in hand, FDA intends to further enhance our risk-based inspection model to prioritize inspections of compounding pharmacies that operate on a larger scale and ship compounded drugs across multiple state lines. Because these pharmacies’ products reach a much greater number of patients who reside in different states, these entities can pose a significant risk to the entire country when they improperly compound drugs. They also often times present unique oversight challenges to state regulators. As a federal regulator with the know-how and tools to assess and address the risks posed by nationwide drug distributors, FDA would like to work with the states in overseeing these compounding operations and potentially encourage these entities to register with FDA as outsourcing facilities. FDA will be looking for your collaboration and partnership in this endeavor going forward.
FDA is also pursuing a number of initiatives to help the outsourcing facility sector, established by Congress under the DQSA, fulfill its intended function to offer a more reliable supply of compounded drugs needed by hospitals, clinics, and other health care providers. It is particularly important that these facilities be able to meet provider needs for office stocks of non-patient-specific compounded drugs, as they are the only compounding entity that may distribute compounded drugs without patient-specific prescriptions under federal law. As many in this room know, almost four years since the passage of the Drug Quality and Security Act, the outsourcing facility sector is maturing. The sector has grown to a size of approximately 75 registrants, and many of them are still adjusting to the applicable quality standards, as well as working through regulatory complexities, such as obtaining state licensure. FDA intends to continue to develop policies, conduct stakeholder outreach, and oversee compliance efforts with the goal of having outsourcing facilities produce compounded drugs that meet the applicable quality standards, as well as work collaboratively with the states to develop state licensure schemes that are appropriate for the outsourcing facilities.
We are also working on a number of other efforts specific to the outsourcing facility sector as it works to meet regulatory standards and fulfill its intended role in the continuum of care for patients.
I’m pleased to announce that today, FDA released a guide for outsourcing facilities that provides a resource on applicable law and policy, and offers clear instructions to outsourcing facilities on issues such as how to submit product reports, how to register with FDA, and how to pay fees.
Also today, FDA began to post outsourcing facility product reports on our website. Each retrospective report describes compounded drugs made by outsourcing facilities in the previous six-month period. Providers will be able to search these reports to identify potential sources of compounded drugs, including those needed for office stock.
FDA is also working to finalize our current good manufacturing practice, or CGMP, guidance for outsourcing facilities. Recognizing the differences between outsourcing facilities and conventional drug manufacturers, the July 2014 draft guidance proposes policies specifically tailored to compounding operations, such as compounding small batches, and describes circumstances under which FDA would not intend to enforce certain CGMP requirements that apply to conventional drug manufacturers. We recognize that our approach to CGMPs cannot be a one-size-fits-all, but instead, risk-based and carefully tailored to the activities these entities engage in, while maintaining the minimum standards necessary to protect patients from the risks of contaminated or otherwise substandard drug products. FDA is carefully considering comments from various stakeholders on the draft guidance, including requests for policies that would provide outsourcing facilities additional flexibilities as we make revisions to this guidance. We are working hard to get this guidance out in the coming months.
And FDA continues to develop policies to implement the Drug Quality and Security Act provisions that place limits on outsourcing facility activities, such as the limitations on making essentially a copy of FDA-approved drugs and the use of bulk drug substances in compounding. FDA is actively working to finalize its policies regarding the law’s restrictions on making copies and to develop the criteria it will use to evaluate clinical need for compounding with bulk drug substances. We want to make sure our implementation of these provisions is appropriately balanced and consistent with the framework set out by the Drug Quality and Security Act whereby compounding pharmacies and outsourcing facilities each play a role in meeting patients’ needs for compounded drugs.
FDA is also pursuing initiatives to support our state partners and make our inspectional activities more transparent, including an educational session for states on how FDA inspects compounding facilities, and processes to give states additional opportunities to directly observe FDA inspections.
Finally, FDA is actively working to revise the draft standard memorandum of understanding between FDA and states to address inordinate interstate distribution of compounded drug products. FDA is committed to considering all of the public comments we have received and developing an MOU that furthers FDA’s public health mission while preventing unnecessary disruption of pharmacies dispensing compounded drugs pursuant to patient-specific prescriptions.
We take seriously our responsibility to implement the Drug Quality and Security Act consistent with the spirit in which it was enacted, to provide access to compounded drugs for patients who need them, and to protect the public health. We have come a long way over the past five years, but there is more work to be done. We are carefully considering all of the feedback we have received in response to the proposals we have put forward in implementing this important law, and we’ll have more to share in the coming months about how we plan to incorporate this important feedback into our implementation of the Drug Quality and Security Act moving forward.
I know that these next two days will be of great value to FDA staff and we hope they will be to you as well. Thank you for your continued willingness to engage with us as we work together to create a seamless and sound framework in the federal and state oversight of drug compounding on behalf of our nation’s patients.