Drug Manufacturer Recklessly Disregards Manufacturing Deficiencies

Case Overview

This case involves a securities class action claim against a US-based drug manufacturer. The claim focuses on the company’s failure to properly convey information pertaining to warning letters issued by the FDA to its shareholders. The company operates manufacturing facilities in California and Taiwan. Apart from what defendants learned from the FDA, it is alleged that they independently knew or recklessly disregarded the fact that the company had significant, pervasive manufacturing and quality control deficiencies. It is also alleged that they had no reasonable basis to assure investors that the company was capable of clearing the warning letter in a timely manner. The expert needed for this case is someone who is intimately familiar with FDA gCMP and NDA policies, and must be able to review documentation related to the plaintiffs’ claims against the manufacturer.

Questions to the FDA Regulations expert and their responses

Please describe your expertise in FDA gCMP and NDA matters.

I have over 25 years of experience in regulatory affairs, drug development, and GMP compliance. My experience was gained in the FDA, pharmaceutical industry, and consulting environments. I have 10 years of experience at the FDA as a researcher, product reviewer, and credentialed inspector. My industry career began at Genzyme Corporation. I’ve held numerous senior and executive positions in regulatory affairs, quality, and biopharmaceutical development at Teva Pharmaceutical Industries, MDS Pharma Services, and Panacea Pharmaceuticals. While in the FDA, I served as a credentialed inspector. I conducted FDA inspections as a product expert along with the FDA District Office. I also conducted solo inspections for product and cGMP compliance. I served as a subject matter expert to FDA Office of Compliance and Office of General Counsel and participated in the issuance of untitled and titled (Warning Letters) letters. In addition, I reviewed responses to enforcement actions and determined suitability and compliance with regulations. I received internal FDA training on laws and regulations governing and interpreting cGMPs. I was responsible for the review of CMC sections of INDs and BLAs and drafted FDA Guidance documents focusing on cGMP and quality. I received numerous awards in the FDA for my work. While in industry, I designed and built GMP Quality Systems, QA and QC groups in companies. My work was both hands-on, such as drafting BPRs and SOPs, and strategic, such as conducting a gap analysis and bringing a quality system into cGMP compliance. My understanding of cGMPs has been validated by these companies successfully passing inspections by the FDA and EMA and receiving GMP compliance certificates through PIC. I have prepared companies for regulatory agency inspections, led companies during these inspections, and prepared acceptable responses to these inspections (issued Form FDA 483s). In my current position as a consultant, I advise clients on FDA compliance matters, conduct cGMP inspections and gap analyses, prepare companies for inspections, and prepare responses to regulatory agency actions. I also draft CMC sections for INDs and NDAs with a strong emphasis on cGMPs.

Have you ever served as an expert witness on a case involving allegations pertaining to gCMP and NDA issues?

I have served as an expert witness in a similar case. I have been deposed 1 time and have been at trial and have testified 1 time. My testimony was on behalf of the plaintiff.

Have you previously audited or consulted pharmaceutical manufacturers on compliance for the above mentioned concerns?

On a regular basis, I audit and consult pharmaceutical manufacturers on manufacturing and quality control deficiencies.

About the expert

This highly qualified expert has over 25 years of experience in regulatory affairs, drug development, and FDA compliance with a focus on biologics, biosimilars, and biologics/device combination products. This expert earned her BS from the University of Maryland, her MS in biotechnology from Johns Hopkins University, and her MBA from Duke. She has 10 years of experience at the FDA/CBER as a researcher, product reviewer, and inspector for biologics. Her industry career began at Genzyme Corporation and she has since held numerous senior and executive positions in industry at Teva Pharmaceutical Industries, MDS Pharma Services, and Panacea Pharmaceuticals. This expert has also published 5 peer-reviewed articles and presented internationally. Currently, this expert is an adjunct professor at a top university as well as the president of an FDA compliance consultancy.