MDS agreed in
February 2005 to undertake a review of bioequivalence studies that were conducted
at our Ville St. Laurent, Quebec facility during the five-year period from January 2000
through December 2004. This action was in response to FDA inspections that raised issues
about how the studies were conducted. In
2006, the review was expanded to include our
Blainville, Quebec site. Through the course of the review, MDS has taken numerous
corrective actions to meet the FDA’s requirements.
On January 10, 2007 the FDA began to directly notify sponsors of some concerns
with the bioanalytical studies conducted at the facilities and in the timeframe noted
above. Letters were sent to sponsors of pending and approved generic applications related to pending and approved generic drugs included in
the Five-Year Review timeframe and conducted at St. Laurent and Blainville. Those sponsors
have been informed that they can address FDA concerns about the accuracy and validity of
their studies by taking one of the following three actions:
- Repeat their studies, or
- Re-analyze their original study samples, or
- Independently audit original study results.
The FDA recommends that these actions occur within a six-month timeframe from the date of the letter.
The FDA also sent similar communication to all innovators who submitted New Drug Applications
during this period to identify any studies conducted at the St. Laurent or Blainville
bioanalytical laboratories during this period.
The FDA has stated it is taking this action “as a precautionary measure to ensure that
data submitted to the Agency and used in making approval decisions is of the highest
quality.” At the same time, the FDA made clear that its adverse event surveillance
monitoring program “has not detected any signals or any evidence that any of the drugs
involved pose a safety risk or that there has been any impact on efficacy. FDA does not
have any evidence that there are problems with the quality, purity, or potency of the
affected drug products.”
The Five-Year Review and FDA action relate only to the St. Laurent and Blainville
bioanalytical business. It does not relate to the other business conducted at those
sites, the bioanalytical work conducted at the Lincoln, Sittingbourne and Zurich, or
any of MDS Pharma Services other lines of business.
With this latest development, the FDA has clarified the path for MDS Pharma Services
bioanalysis clients to bring closure to the agency’s review of bioanalytical studies
conducted at our facilities in St. Laurent and Blainville, Quebec, from January 2000
through December 2004. As a result, MDS Pharma Services has ended the retrospective Five-Year
Review and turned our efforts and resources to supporting our clients as they comply
with these new requirements.
