Last week has been a bustling one for Toronto-based life sciences company MDS and its pharma services business, but the company could finally see the light at the end of the tunnel.
"With this latest development, the FDA has clarified the path for MDS bioanalytical clients to bring closure to the agency's review of bioanalytical studies conducted at our facilities in St. Laurent and Blainville, Quebec, Canada from January 2000 through December 2004," MDS' spokesperson Catherine Melville told OutSourcing-Pharma.com.
Last Monday, while MDS' president and CEO, Stephen DeFalco said to a JP Morgan healthcare conference in San Francisco that the company had already taken a hit of about CAD$31m (€20.5m) from the regulator's probe of its operations in Quebec, the FDA was getting ready to announce the last - but definitely not least - part of its review.
The agency urged companies that have included bioequivalence tests performed by the pharma services unit of MDS between 2000 and 2004 in their drug applications to repeat or confirm the studies, because it is concerned about their accuracy.
MDS Pharma is a company contracted to perform pharmacokinetic testing services for a number of drug companies. A pharmacokinetic study, which measures the level of drug in a patient's blood, can be part the FDA drug approval process.
The FDA said more than 1,000 brand-name and generic drugs that have been approved or submitted for approval since 2000 may have included MDS data in their applications.
According to the regulator, inspections of two of MDS Pharma Services plants in Quebec found a range of problems with testing procedures, including failure to identify and fix sources of contamination in tests, which measured drug levels in the blood of patients.
MDS' clients have been given six months take one of the three following actions: repeat their bioequivalence studies, or re-analyse their original study samples at a different bioanalytical facility, or independently audit original study results.
"Clients do have study data from the agency's review and we expect that a good number of them will choose the last option to have the original study results audited independently," said Melville.
While this will not result in the removal of any drugs from the market, it could delay approval of pending drug applications.
However, the FDA stressed that the retesting is only a precautionary measure and it also made it clear that it does not have any evidence that there are problems with the quality, purity, or potency of the affected drug products.
The regulator said it has found that MDS studies were included in 140 generic drugs applications that have already been approved and 77 drugs waiting for approval.
Establishing how many brand-name drugs may have used MDS data is more difficult because these products often include 30 or more of these types of tests in their FDA applications. The FDA said it is sending out more than 900 letters to drugmakers related to products approved since 2000, asking them to notify the FDA of any MDS-conducted trials.
In a bid to limit the damage, MDS announced last week that it has decided to end its own retrospective review of the bioanalytical studies to focus on supporting its clients with the independent audits.
"The cost of the FDA review has had an impact on performance in our bioanalytical business and to a lesser extent in our early clinical research business," said Melville.
However, if the outcome of the review is positive, this week could mark the end of years of turmoil for MDS.
The nightmare originally started in July 2003 for MDS when an FDA inspection found problems with 32 out of 5,000 samples at a MDS Pharma Services facility in Montreal.
In February 2005, MDS then agreed to undertake a review of bioequivalence studies which were conducted at the St. Laurent facility from January 2000 through December 2004.
Through the course of this review, MDS has taken numerous corrective actions to meet the FDA's requirements, but thus far "has not yet been able to fully satisfy the FDA", it said in a statement last week.
"While we are disappointed in the time and effort that it has taken to get to this course of action, we believe that it will benefit everyone involved to have a crisp path forward to resolve this issue," said Stephen DeFalco, president and CEO of MDS.
"We will fully support our clients with data and information from their studies to help bring this issue to a rapid and complete resolution."
Now MDS can only hope that it will avoid the worst case scenario - the company could face lawsuits from its former clients which could result in millions of dollars of loss.
But Melville wouldn't comment on that nor would she give an estimation of the costs for retesting.