What GAO Discovered
The COVID-19 pandemic revealed vulnerabilities within the medical provide chain that led to drug shortages. The Meals and Drug Administration (FDA) has highlighted superior manufacturing—progressive applied sciences that enhance product high quality and course of efficiency—as a strategy to improve provide chain resiliency. Nevertheless, on the time of this report, few medicine had been made utilizing superior manufacturing (see determine).
3D printing of medication, an instance of superior manufacturing
FDA has three efforts targeted on growing superior manufacturing for medicine associated to (1) trade engagement, (2) coverage and steering, and (3) analysis. Through the COVID-19 pandemic, FDA leveraged its trade engagement effort to approve two medicine for the therapy of a COVID-19 complication, that are made utilizing superior manufacturing know-how. GAO discovered, nonetheless, that FDA lacks info on the extent to which its trade engagement and coverage and steering efforts encourage adoption of superior manufacturing. It’s because FDA has not documented and finalized efficiency objectives—defining what it expects these efforts to realize and efficiency measures—to commonly assess progress the company is making in attaining these objectives. Taking these steps would assist FDA make knowledgeable program administration choices, together with the allocation of finite assets.
The 15 trade stakeholders GAO interviewed reported that regulatory challenges contributed to uncertainty about when and whether or not a drug manufactured utilizing superior manufacturing will likely be accredited. This uncertainty weakens the enterprise case for, and contributes to sluggish adoption of, superior manufacturing. For instance, based on stakeholders, the unfamiliarly of FDA software overview employees with superior manufacturing might result in delays in approval. FDA has taken steps to deal with regulatory challenges, together with utilizing its trade engagement program to offer alternatives for firms to debate new applied sciences with FDA and its analysis program to familiarize employees with superior applied sciences, akin to by means of a yearly coaching on 3D printing.
Why GAO Did This Research
FDA, a element company throughout the Division of Well being and Human Providers’ (HHS), is chargeable for making certain that medicine marketed within the U.S. are secure and efficient. The company additionally performs a job in supporting manufacturing innovation. GAO has beforehand reported on challenges FDA has confronted in its oversight of the drug provide chain and deficiencies in FDA and different HHS entities’ preparation for and response to public well being emergencies. As such, GAO has designated each as high-risk areas.
The CARES Act features a provision for GAO to report on the federal pandemic response. This report (1) examines FDA’s efforts to assist superior manufacturing, together with in response to the COVID-19 pandemic. As well as, it (2) describes stakeholders’ views on the regulatory challenges to growing the usage of superior manufacturing for medicine and (3) describes FDA actions to deal with challenges to growing the usage of superior manufacturing. For this work, GAO reviewed FDA paperwork, nationwide provide chain resiliency methods, and interviewed FDA and 15 drug trade stakeholders, together with firms with accredited medicine and people searching for approval.
