On March 31 2017, FDAnews Drug Daily Bulletin reported that “EMA Requests Suspending Sales of Hundreds of Drugs Due to Flawed Data from Indian CRO…The EMA is recommending that the European Commission suspend the sales of more than 300 generic drug formulations that were approved from flawed bioequivalence studies conducted at two of Micro Therapeutic Research Labs’ facilities in India. The EMA is calling for the suspension of sales after inspections of the two facilities by Austrian and Dutch authorities showed that — between June 2012 and June 2016 — the company mispresented study data and failed to manage data and documentation appropriately”. The full story, reported by EMA in a March 24, 2017 Press Release may be found here.
Recently, we posted a paper entitled, “A drug development overview of pharmacokinetic principles related to ANDA/505(b)(2) submissions” which concludes as follows: “Many of us recall the incident during the first decade of the 21st century when, after several inspections of a well-known CRO, FDA called into question PK data spanning a four-year period, including multiple approvals. In doing so, FDA issued over a thousand notifications to companies with both pending and approved applications, noting that significant concerns about the validity of the results of the studies in support of marketing applications existed. As such, options offered by FDA included, repeat of the BE studies, re-assay of study samples at a different bioanalytical facility, or scientific audit by a qualified independent expert, knowledgeable in the area of BE studies and bioanalytical data. PDG® conducted a number of those scientific audits and has designed a multitude of BA/BE studies for a variety of applications.”
Please feel free to contact us if you are concerned that your BA/BE data may be in question.