Washington, DCIt's a hangover of sorts from the Heparin Contamination scare of three years ago. That's when tainted heparin was traced back to the unsanitary production of pure heparin via unregulated sweatshops in China and the introduction of a mystery contaminant. But what of the checks and balances that would help to catch a problem and stop it dead in its tracks before it gets to market?
Heparin marketed by Baxter and found to be tainted was processed by Scientific Protein Laboratories (SPL) of Wisconsin. As part of an ongoing investigation by the US Food and Drug Administration (FDA) into the Heparin recall, the federal drug regulator undertook an inspection this past September that identified various failures of and deviations from good manufacturing practices (GMP).
That inspection, reported FDA Week on February 4, resulted in the issuance of a warning letter that took aim at SPL's alleged delayed investigation into contaminated lots of heparin which served as the foundation for many headlines starting in 2008 and beyond. This most recent warning letter from the FDA, dated January 20 of this year, also questions the company's response to the September 2010 inspection by the agency.
A warning letter is an official notification from the FDA that the regulator has concerns. In this case, the FDA took SPL to task for failing to evaluate the GMPs of laboratories under contract with SPL with regard to processing the raw materials that ultimately go into Heparin Injections.
While the FDA acknowledged that SPL updated its procedures used to verify the qualifications of its contractors, the agency nonetheless found the company wanting.
"We are concerned about your firm's fundamental understanding of what is required by your Quality Unit and the regulatory expectations for a firm that enters into agreements with contract testing laboratories," according to an FDA Week summary of the letter. "Although you have agreements with other firms that may delineate specific responsibilities to each party, you are ultimately responsible for the quality of your products and the reliability of test results."
There was also some concern with regard to the timeliness of SPL's own investigation into the matter at hand. "The manner in which you addressed this problem is very worrisome with respect to the timeliness of the investigation, the identification of all potentially affected drugs, and implementing appropriate actions to resolve these issues," according to FDA Week, quoting contents of the letter. "Be advised that your firm has the responsibility to ensure the quality, safety, and integrity of its drugs."
In 2008 Heparin IV patients were beginning to experience adverse reactions—some serious—that had not been seen previously. Beyond the allegedly deplorable conditions in the mom-and-pop shacks in China where pure heparin is fashioned from the intestines of swine, there appeared a contaminant that was apparently used in a supposed effort to achieve more value for the supplier at the potential risk of the patient. The contaminant was not caught by the regular series of checks and balances normally in place along the pharmacy pipeline.
In a statement, SPL indicated that it had already resolved many of the issues in the January 20 warning letter and would continue to cooperate with the FDA. The statement said it was not aware of any adverse health issues or events associated with recently recalled Heparin injection.
While the FDA was harsh on SPL, the FDA itself has not put its best face forward either according to bipartisan members of the Energy and Commerce Committee, having expressed concern over the FDA's response to the crisis. Health advocates are hoping for the introduction of a bipartisan bill in an effort to ensure no one is ever again sickened by Heparin IV drip.
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