In yet another example of the inadequacy of federal regulators to protect patient health, the FDA this month issued recommendations for measures to ensure that Heparin, the popular blood-clot prevention drug, was produced safely. While our products liability attorneys applaud the issuance of such recommendations, it is important to note that the agency has finally taken this step four years after the contamination scare which rocked drug users worldwide.
Heparin, a blood thinner derived from pig intestines. The drug was previously produced by Baxter International, Inc., a major U.S. pharmaceutical supplier, but the company sold this portion of its business last year to Hikma Pharmaceuticals Plc.
In the early months of 2008, the FDA first began receiving reports of problems with Heparin, with users reporting serious reactions to the drug. Many users were hospitalized, left on dialysis, and even killed. These problems were traced to the Heparin – and led to a large products liability problem that rocked the international pharmaceutical industry.
The FDA then conducted a probe, and determined that a contaminant was present in some Heparin batches. The contaminant was then traced to certain of Heparin’s active ingredients, which were themselves manufactured in China. Subsequent investigations determined that the contamination with oversulfated chondroitin sulfate (OSCS) “appeared” to be intentional – a move by the Chinese manufacturers to use OSCS as a filler to reduce the costs of production. Hikma asserts that it now uses only materials from the U.S. and Canada in the production of Heparin.
The Heparin problems triggered massive public outcry, and eventually led to congressional hearings about drug products and components manufactured in foreign plants – and the lack of oversight and inspections at those plants.
The FDA posted the draft guidance on its website, stating that it was designed to assist the manufacturers of Heparin’s active ingredients (and the finished product) to avoid contamination. Said FDA Commissioner Margaret Hamburg, “We’re making sure we have systems in place to prevent that particular problem.” In addition to the original contamination, the FDA has also expressed concern about the substitution of cow-based heparin, which could lead to contamination with mad-cow disease.
The draft guidance calls for testing of each shipment of crude heparin, including testing to determine the species origin (to ensure that it is pork-based), and to look for the OSCS. Testing would be done before the manufacture of the drug Heparin from the crude ingredients. The draft guidance also calls for manufacturers to audit their suppliers.
While encouraging, the FDA’s draft guidance is a classic case of “too little, too late.” First, it is phenomenal that the FDA has taken four years to take action on this very serious problem. The draft will now be open for comment for 60 days, at which point the FDA will decide whether to make changes, resulting in additional delays, or issue the guidance in non-draft form.
In addition, the proposed guidance is just that – guidance. Even if adopted, it would simply be a list of recommendations for manufacturers, and would not create any legally-binding, or enforceable, rules or responsibilities.
Our top products liability attorneys are disappointed that FDA action has taken this long, and dismayed that, in the end, the FDA has chosen to issue only “guidance,” without taking any real action to protect consumers. We urge the agency to reconsider, and to make this guidance binding, requiring manufacturers to take these very basic steps to protect U.S. patients and the public.
For a free consultation with an experienced Chicago products liability lawyer at Passen Law Group, call us at (312) 527-4500.