Heparin Products the Target of Deliberate Adulteration, Says Baxter CEO

Baxter’s heparin products appear to have been the target of a deliberate adulteration scheme, Baxter (Deerfield, IL) CEO Robert L. Parkinson said on April 29, 2008, in testimony before the US House of Representatives’ Committee on Energy and Commerce, Subcommittee on Oversight and Investigations.

Parkinson described the heparin situation as “a global and industry-wide crisis, with a root cause that was so novel and so insidious as to avoid the quality systems of a multitude of companies and the oversight of the world’s most sophisticated drug regulatory agencies.”

Parkinson then outlined the steps Baxter was taking in the hopes to avoid similar situations in the future, including convening a group of scientists whose purpose is to consider all the methods counterfeiters could use to threaten the supply chain. He suggested that the FDA take similar actions as well, to think about threats proactively.

In separate testimony, David G. Strunce, president and CEO of SPL (Waunakee, WI), the majority interest holder of Baxter’s active pharmaceutical ingredient (API) provider, Changzhou SPL (Changzhou, China), stated that because the contaminant, oversulfated chondroitin sulfate, has been found throughout the world, independent of the Changzhou SPL supply chain, the contamination must have occurred upstream of the API manufacturers.

Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, also testified, and agreed with Parkinson that the contamination was probably intentional, although the FDA has yet to prove it. She stated that although the FDA has acknowledged that it did not inspect Changzhou SPL, inspection of that one firm would not have prevented the problem because the heparin contamination is not limited to product from Changzhou SPL alone.

Woodcock also outlined the FDA’s plans for preventing a similar situation from happening again. She said that FDA Commissioner Andrew von Eschenbach has made upgrading the agency’s information technology (IT) systems a top priority. The FDA also has signed a Memorandum of Agreement with China. Under the agreement, all Chinese producers of items covered under the agreement for export to the US must register with Chinese authorities and the Chinese must adopt quality-assurance electronic tracking methods for certain products. The two countries also agreed to timely information sharing with regard to certain inspectional failures at drug manufacturing facilities and shipments of products that may be dangerous. The Chinese will also facilitate and expedite inspections by FDA investigators of Chinese drug plants.

A week earlier, on April 22, 2008, FDA Commissioner von Eschenbach also testified before the Subcommittee about the FDA’s plans for improving the way it ensures the safety of medicinal products that included foreign products. He said that the FDA needs to move from being a “gate-keeper” to being a stronger, more comprehensive import safety authority.

Althought the FDA conducted more foreign drug inspections in 2007 than ever before, foreign inspections are expensive and challenging, he said, because of travel costs, the need for translators, and in some cases, the need for foreign government authorization to enter the country.

The agency is attempting to deal with these challenges, he said, through the “Beyond Our Borders” initiative, which includes increased collaboration with foreign regulators such as through sharing foreign inspection reports. The FDA is also pursuing expanded use of third-party certification to verify compliance with US safety standards
The FDA already has committed to establishing an FDA office in China, where it hopes to have an established presence by the end of 2008. The agency recently has begun talks with Indian officials as well about collaboration in that country.

Von Eschenbach also described plans to improve its IT systems to support inspectional and other safety efforts. Ultimately, however, US manufacturers are accountable for ensuring the safety of foreign-manufactured ingredients, and must examine and test all ingredients before using them in their drug products.