Fact or fiction? Pharmaceutical plants that make prescription drugs have a greater likelihood of being inspected than those making non-prescriptions. FDA drug investigators with increased training find more acts of noncompliance at facilities they inspect. Sites that have changed ownership are more likely to have regulatory problems. If numbers dont lie, these statements are true.Initial findings are finally coming forth from the landmark, number-crunching benchmarking effort undertaken by two researchers, Dr. Jeffrey T. Macher of Georgetown University and Dr. Jackson Nickerson of Washington University. The professors seek to provide statistical understanding of the relationship between FDA regulation and drug company performance, and pinpoint which products and types of manufacturers are likely to draw increased regulatory scrutiny.The pairs work in progress is a comprehensive analysis of two massive data sets. One comprises facts and figures gathered from FDA inspection documentation over a 13-year period, from 1990 to 2003. Under a material transfer agreement with FDA, Macher and Nickerson have collected data from every single site inspection over that periodin total, more than 38,000 inspections of some 3,700 facilities conducted by 783 different drug investigators.The second data set is being assembled from statistics and information gathered from comprehensive Internet-based questionnaires completed by drug firms about their most intimate processes and procedures, and regulatory outcomes, covering 58 facilities. The researchers are working with stragglers, companies that have not yet provided completed questionnaires and statistics, to complete this set.Dr. Macher issued tantalizing tentative findings from the FDA research project at the recent Parenteral Drug Association (PDA) annual meeting in Chicago. He cautioned the audience not to read too much into the numbers just yet, but to begin taking stock of what they might mean for individual firms and the industry as a whole, as well as for FDA.Macher looked at the types of drugs being made at facilities and how they might attract the attention of regulators, and then later lead to compliance or noncompliance issues. Among the tidbits he offered:
- Plants manufacturing prescription drugs have a 13% greater chance of being inspected than those making non-prescription medicines. Once inspected, however, prescription drug facilities are less likely to be found noncompliant.
- Facilities manufacturing antibiotics have a 19% greater chance of being inspected than those making other drugs, while those making vitamins have an 11% greater chance. Antibiotic plants also have a much greater likelihood of being out of compliance, Macher noted.
- Facilities making biologics have a 7% lower chance of being inspected than the average facility.
- Plants that have received an OAI (Official Action Indicated) face a 13% greater likelihood of inspection.
- Investigators who complete FDAs basic drug school have a 7% greater likelihood of detecting noncompliance than they did prior to the school. Completing higher degrees of training (such as courses on sterilization) also increases the likelihood investigators will find compliance issues at a plant. Machers conclusion: training matters.
- Macher also found that investigators who havent done many pharmaceutical plant inspections over the previous 12 months tend to forget their training, and find fewer acts of noncompliance upon returning to drug work. The suggestion, he says, is that investigators benefit from devoting their time wholly to drug investigations, rather than dividing their time between drug, food and device work.
|WARNING LETTER WATCH|
Concept Heidelberg, a GMP consulting and training firm based in Heidelberg, Germany, recently issued its annual analysis of FDA drug-related warning letters issued during the previous year. The report analyzes the 33 letters concerning 21 CFR Part 211, and offers some surprising insight into shifting FDA priorities. (For more information, visit www.concept-heidelberg.de)
Among the findings:
Courtesy of Concept Heidelberg