Congress Will Investigate Digitek Recall And What FDA Knew About Actavis Manufacturing Problems

After Earlier Class 1 Recall Of Digitek, All Acvtavis Drugs Manufactured At Its Little Falls, NJ Plant Were Recalled In August 2008

(Posted by Tom Lamb at DrugInjuryWatch.com)

On October 8, 2008 Representatives John D. Dingell (D-MI), the Chairman of the Committee on Energy and Commerce, and Bart Stupak (D-MI), the Chairman of the Oversight and Investigations Subcommittee, issued a press release, "Dingell, Stupak Again Question Whether FDA Knowingly Allowed Dangerous Drugs to be Sold to U.S. Consumers".

On that same day Reps. Dingell and Stupak sent a letter to FDA Commissioner Andrew C. von Eschenbach to inform him that Congress will investigate the facts giving rise to the Class 1 recall of Digitek in the spring of 2008 as well as the August 1, 2008 recall of all generic drugs manufactured at the Actavis Totowa LLC at its plant in Little Falls, New Jersey (formerly operated by Amide Pharmaceuticals).

From the October 8 press release we get these comments from Reps. Dingell and Stupak:

“Once again our Committee is forced to examine whether FDA can do its job to protect Americans from drugs produced in a manner that threaten the health and lives of American consumers,” said Dingell. “Apparently, companies such as Actiavis and Ranbaxy are allowed to operate and continue to receive approvals to manufacture other drugs long after FDA knew or should have known that their manufacturing operations were out of control and potentially lethal.”

“The Center for Drug Evaluation and Research (CDER) has ignored its mission to protect the public health,” said Stupak. “In case after case, we have seen FDA bend over backward to keep scofflaw companies in business and highly-questionable drugs on the market. A wholesale change in the decision-making apparatus at CDER is clearly needed if Americans are to trust the drugs prescribed by their doctors.”

In their October 8 letter to Dr. von Eschenbach, Reps. Dingell and Stupak revisit the reason for the spring 2008 Digitek recall, and go on to explain the basis for this Congressional investigation of what the FDA knew about Actavis manufacturing problems and when the agency knew it:

That drug was recalled

"due to the possibility that tablets with double the appropriate thickness may
have been commercially released. These tablets may contain twice the
approved level of active ingredient than is appropriate. Digitek is used to treat
heart failure and abnormal heart rhythms .... Death can also result from
excessive Digitalis intake."

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. 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.

Among the items requested by Reps. Dingell and Stupak as part of this investigation by Congress:

...for all FDA-regulated products that Actavis has received approval to sell
into domestic commerce since January 1, 2003, or that Actavis imports into this country from abroad regardless of approval date, please provide:...

3. All documents relating to any "for cause" inspection of the Actavis firm, its
subsidiaries, or its active pharmaceutical ingredient (API) suppliers;...

7. A list of FDA personnel that conducted or reviewed each inspection listed above.

This type of information may help determine the extent, in terms of quantity and time, of the so-called "double-dose" Digitek pill problem, which has remained unclear since Actavis first announced the Digitek recall on April 29, 2008.

According to the October 8 letter to the FDA, the requested documents are to be produced "no later than two weeks after the date of this letter."

We will report further on this Congressional investigation of Digitek, Actavis, and the FDA as we learn more about it.