|FDA now believes that heparin tainting was deliberate. Source: Zaz Report|
Federal drug regulators proposed Tuesday during a congressional hearing that the contaminant added to heparin, which has been connected to 81 deaths and 785 severe allergic reactions, was added deliberately.
"The FDA's working hypothesis is that this was intentional contamination, but this is not yet proven," Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research, said.
Baxter International knew the FDA never inspected the active pharmaceutical ingredient plant, Changzhou SPL, implicated in manufacturing contaminated batches of heparin leading to adverse events and deaths, according to congressional investigators.
In addition, the investigators said that Baxter did not audit the facility until after marketing heparin sourced from the site for at least two years, David Nelson, senior investigator with the House Oversight and Investigations Subcommittee, reported at the hearing.
The FDA’s inspection found several significant deviations from good manufacturing practices, for which the agency issued a warning letter to Scientific Protein Laboratories (SPL). The facility is majority owned by SPL, which has facilities in China and Waunakee, Wis.
Last month, the FDA confirmed that some of the heparin contained oversulfated chondroitin sulfate, an altered version of chondroitin sulfate typically made from animal cartilage that is used as a dietary supplement.
Oversulfated chondroitin sulfate mimics heparin, which is why it was not detected in routine testing, said Rep. Bart Stupack, D-Mich., chairman of the House Energy and Commerce subcommittee on oversight and investigations, during the hearing on Tuesday.
The FDA said it will continue to investigate Baxter’s supply-chain.
Robert Parkinson, CEO and chairman at Baxter reiterated Stupack’s comments that oversulfated chondroitin sulfate was too close to actual heparin to detect.
David G. Strunce, CEO of SPL, agreed with the assessment of the federal regulators at the hearing: “It seems to us that it's an intentional act.”
As a result of this crisis, Parkinson told Wall Street analysts that the company has “not made a decision whether or not we are going to re-enter [the U.S. market] with heparin,” according to the Chicago Tribune.
The product generates $30 million of Baxter’s more than $11 billion in annual sales.
The committee also heard from families of patients who received contaminated heparin and subsequently died. FDA News reported that one man, Leroy Hubley, lost both his wife and son due to reactions to the contaminated substance. “The FDA and Baxter have not done their job,” he testified. “I want to know what is going to be done to rectify the matter.”
The FDA has instituted a screening process for all imported heparin. Under the program, U.S. companies using imported heparin need to either enter into an agreement with the agency to employ sophisticated identity tests to ensure the products are genuine, or they will be detained at ports of entry.
Speaking at the hearing, Rep. John Dingell, D-Mich., chairman of the House Commerce and Energy Committee was skeptical of the FDA’s assurances that imported heparin is being checked, given the constraints in screening imports. “You folks are more trusting than a kindergarten class,” he said.
Dingell said the FDA was "woefully lacking" in personnel, effective policies and will at the highest level in its regulation related to the heparin scandal. "Our citizens can no longer trust that their food, drugs, or medical devices are safe when the FDA says they are," Dingell noted in his opening remarks.
During the committee hearing, Woodcock told lawmakers that for the FDA to inspect every foreign manufacturing facility every two years, roughly $225 million was needed annually. To inspect domestic sites once every two years would take an additional $100 million.
Stupak and Dingell said they hoped Congress would soon pass legislation that would increase both funding and oversight of the FDA.