Government probes FDA actions in Actavis recalls
The House Energy and Commerce Committee is investigating alleged FDA shortcomings to request more information about Actavis recalls, including withdrawal of all products from its Little Falls, N.J. plant.
In August, Actavis Totowa, a Morristown, N.J., manufacturing division of pharma company Actavis Group, recalled more than 60 generic drug products from hospitals and pharmacies that were manufactured at its Little Falls plant, following recommendations from an FDA inspection early this year.
Also, Actavis Totowa initiated a separate Class I voluntary recall of all lots of its heart failure treatment Digitek in May, as a precautionary measure, since the tablets might have contained twice the approved level of the active ingredient.
Committee Chairman John Dingell, D-Mich., and Oversight and Investigations Subcommittee Chairman Bart Stupak, D-Mich., sent the FDA Commissioner Andrew von Eschenbach a letter requesting related documents.
“Recalls of this seriousness causes us to question whether FDA was deceived regarding the current good manufacturing practices of this company, or did FDA simply fail to conduct adequate and timely inspections of these facilities,” according to the letter.
Dingell and Stupak also questioned whether the “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.”
To advance in their probe, Congressmen have requested a series of documents from the FDA, relating to its correspondence with the company.
In August, Actavis Totowa, a Morristown, N.J., manufacturing division of pharma company Actavis Group, recalled more than 60 generic drug products from hospitals and pharmacies that were manufactured at its Little Falls plant, following recommendations from an FDA inspection early this year.
Also, Actavis Totowa initiated a separate Class I voluntary recall of all lots of its heart failure treatment Digitek in May, as a precautionary measure, since the tablets might have contained twice the approved level of the active ingredient.
Committee Chairman John Dingell, D-Mich., and Oversight and Investigations Subcommittee Chairman Bart Stupak, D-Mich., sent the FDA Commissioner Andrew von Eschenbach a letter requesting related documents.
“Recalls of this seriousness causes us to question whether FDA was deceived regarding the current good manufacturing practices of this company, or did FDA simply fail to conduct adequate and timely inspections of these facilities,” according to the letter.
Dingell and Stupak also questioned whether the “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.”
To advance in their probe, Congressmen have requested a series of documents from the FDA, relating to its correspondence with the company.