FDA Funding

On March 11 FDA Commissioner Scott Gottlieb provided a statement in the request for new FDA Funding. The full FDA statement is available here. Below is the excerpt concerning funding requested to Strengthen the FDA’s oversight of compounded drugs to help secure patient safety:

The practice of compounding medicine can provide important public health opportunities. The FDA’s compounding program—including implementation of the compounding provisions of the law—is a priority for the agency. We recognize that we must balance the need to preserve access to appropriately compounded drugs for patients who have a medical need for these products with the need to help protect patients from poor quality compounded drugs that could cause harm. Although compounded drugs can serve an important role for certain patients whose medical needs cannot be met by an FDA-approved drug product, it’s important to understand that compounded drug products haven’t undergone FDA premarket review for safety or effectiveness. We’ve taken steps in recent years to advance this goal and we’ve shared priority areas that we’re focusing on in our 2018 Compounding Policy Priorities Plan.

To address both the need for, and safety of, compounded products, the FDA is supporting new policy development for outsourcing facilities, including efforts to improve the quality of outsourcing facilities’ compounded products. We’re also helping address providers’ needs for office stock of compounded medications. In 2020, for example, we’re standing up a Compounding Center of Excellence, to provide training programs on good manufacturing practices for outsourcing facilities, and adding a cadre of inspectors for outsourcing facilities. By engaging with outsourcing facilities and states, we can help the domestic outsourcing facility industry grow and adhere to quality standards to protect patient health, including by finalizing guidance and developing a rule for good manufacturing practices for outsourcing facilities, and evaluating hundreds of nominations for the bulks list.

The Budget provides $76 million for these and additional efforts, an increase of $25 million above the FY 2019 annualized CR level. It will support compounding activities to better inform facility, process and system design; establish a list of bulk drug substances that can be used by outsourcing facilities; increase engagement with industry to promote compliance; and help pharmacies that want to become outsourcing facilities efficiently engage the regulatory process.

We’ve made important progress in recent years on putting forth and implementing more effective compounding policies. As the FDA defines and advances these policies, we’re committed to a framework that closely aligns with our mission to protect consumers and promote opportunities to improve health.