Representatives John Dingell and Bart Stupak have written a letter to FDA Commissioner Andrew von Eschenback requesting information relating to the agency’s interactions with Actavis Totowa.
This letter asks some tough questions of the agency, with the Representatives trying to ascertain the competence of the FDA as part of the US House Committee on Energy and Commerce’s probe.
Regarding Actavis the letter says: “Recalls of this seriousness [cause] us to question whether FDA was deceived regarding the current good manufacturing practices (cGMPs) of this company, or did FDA simply fail to conduct adequate and timely inspections of these facilities.
“A more important question is whether FDA permitted additional products from this firm onto the market while the agency knew or should have known about the breakdown of manufacturing practices at Actavis or its subsidiaries.”
The letter was written as a result of a series of recalls by the Icelandic generics manufacturer, Actavis. It cites the recall of fentanyl transdermal patches by an Actavis subsidiary in February and the Digitek manufacturing defect.
This culminated in the recall of all products manufactured at the Little Falls, New Jersey site where Digitek is produced.
The letter to Eschenback questions the FDA’s insistence that the quality of products manufactured at other Actavis facilities was not in doubt. Stupak and Dingell’s doubt in the FDA assertion is based upon the fact that the recalled fentanyl patches were made at a different plant.
A consequence of the Representatives’ unease is that they are seeking extensive documentation from the FDA, covering all Actavis products that have been approved for sale since 1 January 2003. They are also seeking documentation of all Actavis products imported to the US since this date, regardless of when they were approved.
For all products the Representatives are seeking every document that conveys preapproval inspection assignments or that describe the inspector’s tasks and findings. This includes any Notice of Inspectional Observations (form 483s) or Establishment Inspection Reports (EIRs).
The letter also requests a list of all active pharmaceutical ingredient (API) suppliers, with details of what inspections were undertaken and what the findings were.
In addition, a list of laboratories that were used to perform bioequivalence studies, when these tests took place and what the results were is requested. Details of inspections of these laboratories are also sought.
The letter specifically requests documents relating to any “for cause” inspections of Actavis, its subsidiaries or suppliers. “For cause” inspections are usually undertaken in response to a complaint or other tip-off.
Finally, the Representatives request a list of all the FDA personnel that conducted or reviewed any of the inspections relating to Actavis.
The FDA has two weeks to provide the requested documents. A copy of the letter can be found here.