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Digitek, Other Generic Drug Recalls Prompt Congressional Probe of Actavis Totowa

Oct 10, 2008 | Parker Waichman Alonso LLP

Actavis Totowa, the company that has recalled a variety of drugs this year, including Digitek tablets and fentanyl patches, has attracted the attention of lawmakers on the House Energy and Commerce Committee.  Chairman John Dingell (D-Mich.) and Oversight and Investigations Subcommittee Chairman Bart Stupak (D-Mich.) have sent a letter to the Food & Drug Administration (FDA) seeking information about the Actavis recalls.

In April 2008, Actavis Totowa recalled Digitek tablets because some of the medication contained twice the active ingredient normally found in Digitek.  According to the FDA, the Digitek defect could cause serious and even fatal reactions in users. The FDA deemed the Digitek recall a Class I recall, its most serious recall.

In August, Actavis issued another recall of all generic drugs made at its Little Falls, N.J. facility.  The recall was prompted by an inspection at the facility which revealed that operations did not meet the FDA's standards for good manufacturing practices.  The Little Falls factory also produced some of the faulty Digitek recalled earlier.  

When the Actavis generic drug recall was announced, the FDA said that products made at the company's other manufacturing facilities were not suspect.  But in a letter to FDA Commissioner Andrew von Eschenbach,  both Dingell and Stupak questioned that assertion.   They note that at least one other Actavis unit, Actavis Atlantic, LLC, had recalled fentanyl pain patches in February 2008 because of a dangerous manufacturing defect.  

Their letter asks von Eschenbach to provide their Committee with all information pertaining to all FDA-regulated products that Actavis has received approval to sell since January 2003, as well as all drugs Actavis imports to the U.S. regardless of approval date. The Congressmen want to know if the FDA was deceived by Actavis when it inspected the company's facilities, or if the agency failed to do adequate inspections.

The House Energy and Commerce Committee is also investigating the FDA's role in another generic drug scandal  involving the Indian drug maker Ranbaxy.  Last month, the FDA banned generic drugs made at to Ranbaxy plants in India.  In addition to the import alert, the FDA said it won’t approve any drug applications that list the two suspect Ranbaxy plants as a source of ingredients.

In February, federal agents raided the US corporate offices of Ranbaxy in New Jersey, as well as a  manufacturing facility in the state.  The raid - and criminal investigation - was prompted, in part, by problems uncovered in FDA inspections a year earlier at the company’s plant in Paonta Sahib, India.  That inspection found inconsistencies in the company’s manufacturing processes and maintenance of data.

In July, US prosecutors filed a motion in federal court in Maryland alleging that Ranbaxy forged documents relating to an investigation into the quality of the company’s drugs sold in the this country.  The investigation is also looking into allegations that Ranbaxy  made weak or adulterated HIV drugs that were given to thousands of AIDS patients in Africa. Prosecutors have accused the company of concealing violations of good manufacturing practice regulations from FDA.

In a letter written to the FDA this July, Dingell and Stupak wrote  that court documents related to the Justice Department probes of Ranbaxy indicated that for 18 months the FDA was aware of problems but “did nothing to remove the suspect products from the market, or even notify the pharmacists in this country”.