Congress Probes FDA's Inspection Process of Actavis

October 15, 2008
Patricia Van Arnum
ePT--the Electronic Newsletter of Pharmaceutical Technology

John Dingell (D-MI), chairman of the US House Committee on Energy and Commerce and Bart Stupak (D-MI), chairman of that committee's Subcomittee on Oversight and Investigations, directed a letter to US Food and Drug Administration Commissioner Andrew C. von Eschenbach to request further information regarding FDA's process for inspecting manufacturing facilities of the generic drug manufacturer Actavis following several product recalls by the company.

Washington DC (Oct. 8)-John Dingell (D-MI), chairman of the US House Committee on Energy, and Commerce and Bart Stupak (D-MI), chairman of that committee’s Subcomittee on Oversight and Investigations, directed a letter to US Food and Drug Administration Commissioner Andrew C. von Eschenbach to request further information regarding FDA’s process for inspecting manufacturing facilities of the generic drug manufacturer Actavis following several product recalls by the company. 

In late July, Actavis Totowa LLC, the US subsidiary of the generic drug manufacturer Actavis Group, announced a voluntary recall to the retail level of all drug products manufactured at its Little Falls, New Jersey, facility. The recall was a precautionary, voluntary action following an inspection conducted by the FDA  earlier this year.

That recall was the third recall by Actavis in 2008. In April, Actavis Totowa initiated a Class I nationwide voluntary recall of “Digitek” (digoxin tablets, USP, all strengths) for oral use. That recall was due to the possibility that tablets with double the appropriate thickness may have been commercially released and that the tablets may have contained twice the approved level of active ingredient. 

In March, Actavis’ subsidiary Actavis South Atlantic LLC recalled fentanyl transdermal system CII patches sold in the United States. The recalled patches were manufactured by Corium International (Menlo Park, CA), a contract manufacturer for Actavis. The fentanyl transdermal system patches recalled may have had a fold-over defect that has the potential to cause the patch to leak fentanyl gel. As a precaution, Actavis recalled the products.

In their letter to FDA, Dingell and Stupak called into question FDA’s role in inspecting the company’s facilities and whether it should have allowed the company to continue manufacturing in light of earlier recalls.

“Recalls of this seriousness causes 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,” said the letter. “A more important question is whether FDA permitted additional products from this firm on the market while the agency knew or should have known about the breakdown of manufacturing practices at Activis or its subsidiaries.”

The Congressmen are requesting that FDA provide information and related documents on all FDA-regulated products that Actavis received approval to sell in the United States since January 1, 2003, including any products that the company may be importing to sell in the country. The specific information requested includes the following:

• Preapproval inspection assignments
• Documents that describe the tasks undertaken by FDA investigators during the preapproval inspections, including any Notice of Inspectional Observations (Form 483s) or establishment inspection reports (EIRs)
• Documents relating to “for cause” inspection of Actavis, its subsidiaries, or its suppliers of active pharmaceutical ingredients (APIs).
• A list of all API suppliers and any Form 483s or EIRs, or other documents that would describe the tasks of FDA inspectors of those suppliers
• A list of laboratories performing bioequivalence studies for Actavis
• Any 483, EIR, or other document that would the inspections of those laboratories providing bioequivalence testing
• A list of FDA personnel that conducted or reviewed each inspection.

The Congressmen requested the documents no later than Oct. 22, 2008.