The agency was unsure how many new drugs might have relied on studies carried out by MDS, according to news accounts, so it asked the manufacturers of every new drug approved between 2000 and 2004 2014 some 900 medicines 2014 to check to see if MDS had conducted any relevant tests.
The FDA made no effort to warn doctors or patients that it now had doubts about the data underlying some of the drugs it had approved. Instead, the agency sounded a public "all clear".
"FDA does not have any evidence that there are problems with the quality, purity, or potency of the affected drug products," the agency said at the time.
MDS Inc., the parent company of MDS Pharma Services, would eventually shut down the two Quebec facilities where the problems occurred. Other parts of the company's drug testing business were sold off piecemeal to various competitors.
At least five senior executives from MDS found a new home at Cetero, including Cetero's chief scientific officer, its vice president in charge of quality assurance, and its head of business development. The chief scientific officer said he was not involved in MDS' Quebec facilities or the Houston lab where Cetero's problems occurred; the others either declined to comment or did not respond to inquiries.
In 2012, Cetero filed for Chapter 11 bankruptcy and emerged with a new name, PRACS Institute, which in turn filed for bankruptcy on March 22 of this year.
From ProPublica.org (find the original story here); reprinted with permission.