Remarks at the FDA Federal Partners Meeting May 10, 2018

Speech | In Person

• Speech by: Anna Abram

FDA Federal Partners Meeting
White Oak, MD

(Remarks as prepared for delivery)

Good morning and welcome to FDA.  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 participating in today’s Federal Partners meeting on drug compounding. Partnership and coordination between FDA and our Federal counterparts is essential to improving the quality of compounded drugs and reducing the risks these drugs can pose to patients, while providing access to compounded drugs for patients that need them.  Drug compounding is a significant priority for the agency, and we greatly value your collaboration as we strive to protect the public health.

The tragic fungal meningitis outbreak of 2012, in which over 700 patients were sickened, and over 60 lost their lives after receiving contaminated compounded medicine, was a major catalyst for action.

At the time of the outbreak I was working in the United States Senate for the Senate Health, Education, Labor, and Pensions Committee, and I had the privilege of participating in the bipartisan effort to develop and pass The Drug Quality and Security Act of 2013, or DQSA. This legislation sought to clarify the applicability of existing law on drug compounding, as well as establish a new group of compounders, known as outsourcing facilities, that supply compounded drugs made under a higher production standard than other compounded drugs, oftentimes in large quantities to providers in many states.

FDA is working diligently to implement federal law in a way that appropriately considers the diverse landscape of compounding practitioners and facilities across the country. As others will discuss today, FDA has issued over 20 policy documents on compounding since passage of the DQSA, including three in January of this year, and one in March.  Many of these policy documents were developed to address questions we have received from our regulatory partners and other stakeholders.

And I’m pleased to announce that today we are publishing a new final guidance document in which FDA provides its interpretation of the meaning of the term “facility” in the context of the new outsourcing facility sector. FDA is taking this action to address many questions it has received on this topic, including, for example, questions regarding whether compounding pursuant to patient-specific prescriptions can occur in a separate suite adjacent to, but within the same building as, the outsourcing facility or within the outsourcing facility itself.  FDA hopes that this guidance, like others, helps provide clarity to stakeholders that can help support their internal decision-making regarding current and future plans for their compounding facilities, and that it will help ensure that health care providers and patients know the standards under which the compounded drugs that they purchase are made.

To support its policy work, FDA regularly engages with stakeholders to hear their feedback.  FDA also seeks opportunities to collaborate with other government entities, such as those of you in the room today, as well as state boards of pharmacy.

In the interest of collaboration, I’m pleased to announce that FDA intends to increase its efforts to provide information to state and Federal entities regarding incidents linked to compounded drugs. In the coming months FDA plans to begin to routinely share with states and federal partners, to the extent that we can under our disclosure laws, adverse event reports or complaints involving compounded drugs that are relevant to those states and partners.

Finally, I’m pleased to share that FDA also unveiled today a new website for our compounding program, with a significant amount of new information and educational content. The website provides detailed information on provisions of federal law related to compounding and FDA policies to implement federal law, as well several question and answer documents and other resources organized by topic and by stakeholder.

In January of this year, Commissioner Gottlieb unveiled FDA’s Compounding Policy Priorities Plan and we remain highly focused on advancing these priorities as laid out in that plan.  We are grateful for the opportunity to learn from, and share information with, you as we move forward in these critical public health endeavors.

I know that the next day and a half will be of great value to FDA staff and we hope they will be to you as well.
Thank you for your willingness to engage with us and your shared commitment to patients. We look forward to continued collaboration and partnership in this space.