FDA’s Auditing Resources Are Mostly Spent for Food Facilities, Not Drugs.
(Thursday, May 6, 2021)
If every time you heard about an FDA audit and you guessed it was about audit of drug manufacturing facilities, you guessed wrong. More than 80% of surveillance audits conducted by the FDA are at food facilities, compared to about 4% at drug facilities. There are many such surprising facts in a report on FDA inspections (commonly called “audits”) released this week by the FDA. While FDA’s inability to audit enough drug facilities has been frequently a topic of criticism, even by the GAO, the fact that the main reason for that is sapping of most audit resources by food facility audits, has never been brought up. Due to the high frequency of food facility audits required by the law, FDA does not have sufficient resources left for the audit of health product facilities. So, it uses risk factors such as novelty of the product, complexity of the manufacturing process, and history of compliance, in deciding whether a drug manufacturing facility needs to be inspected. Last year, using these risk factors, FDA decided that more than 95% of market approval applications do not need FDA audit prior to approval; only 600 out of 13,500 market approval applications were deemed to require pre-approval inspections. While some of the decisions regarding whether to audit may be attributed to the pandemic related issues, the trend of 4 out of 5 audits at food facilities, pre-dates the pandemic. About 54% of audits classified as “mission critical” or “prioritized” by FDA are at food facilities, compared to about 13% for drugs. The requirement for this high frequency of food facility audits was created under the Food Safety Modernization Act (FSMA). And these are very expensive audits. Under FSMA, FDA is required to audit a minimum of 19,200 foreign food facilities regardless of risk to public health; each foreign facility audit costs FDA $24,500, and takes about 3 weeks of travel for the inspectors. Hence, it seems that FDA must cut corners for audits for healthcare products. The pandemic has probably created the perfect conditions for FDA to bring this topic to light. FDA is extremely curtailed in its ability to audit all facilities; domestic and foreign, by the pandemic; FDA does not believe it will be able to conduct any foreign surveillance audits till September of this year at the earliest, perhaps till much later. So, this is perfect time to bring out the skeleton from its closet for all to see. In a sidebar to the report, FDA stated it would like the Congress to “allow the agency to conduct inspections of human and animal food facilities at a more risk-based frequency rather than statutory numbers so it can use it’s inspectional resources for drugs”. One FDA report will barely do much to sway the Congress on its own, but it should give the public, industry, and other stakeholders demanding greater oversight of drugs, fodder to discuss with the politicians they lobby to rethink logistics and logic of food and drug audits.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC