In 2008, adverse affects and deaths linked to Baxter’s blood thinner drug heparin revealed contamination in the heparin supply chain originating from an API manufacturer in China. FDA identified oversulfated chondroitin sulfate (OSCS) in the contaminated heparin. In response to the 2008 heparin situation, the United States Pharmacopeia Convention (USP) has revised the quality standards for heparin. Anita Szajek, PhD, and Tina Morris of USP highlight USP’s revisions to the heparin sodium monograph in the September 2012 issue of PharmTech.

Economically motivated adulteration became a major concern after heparin manufactured by Baxter Healthcare was contaminated with oversulfated chondroitin sulfate. FDA told the Government Accountability Office (GAO) that getting information from industry about potential instances of economic adulteration is crucial to addressing the problem. Companies have been reluctant to share this information, but a GAO report suggests a possible solution. Read more »

Dr. Margaret Hamburg, commissioner of the US Food and Drug Administration, spoke about the growing problem of counterfeit drugs at last Friday’s Counterfeit Drug Interchange Conference in Washington, DC, hosted by the Partnership for Safe Medicines (PSM), a collection of more than 60 non-profit organizations focused on the safety of prescription drugs. Read more »

The US Food and Drug Administration has taken a lot of heat in recent years. Events such as the heparin scandal and the recall of Actavis’s (Morristown, NJ) Digitek product have led critics to call the agency a lax and ineffectual protector of the public health. These comments, which I think are partly justified, finally seem to have spurred FDA into action. Several initiatives seem to show an agency that wants to regain its credibility and shield us from dangerous medications. Read more »

The high-profile case of contaminated heparin last year was reason not only to consider issues relating to supply-chain integrity, but it also reminded us how critical a production process is to the quality of a drug substance. Pharmaceutical-grade heparin, a sulfated glycosaminoglycan, is derived from the mucosal tissues of slaughtered meat animals such as pig intestines, and a synthetic route has been elusive. Researchers at the Rensselaer Polytechnic Institute (RPI) report on a potentially interesting solution that may not only be valuable for producing heparin, but may also be a relevant approach for developing other biopharmaceuticals. Read more »

The US Food and Drug Administration was buffeted by questions and criticism last year after the emergence of contaminated heparin. Lawmakers questioned whether the agency had investigated the problem thoroughly and been forthcoming about its findings. Several of FDA’s recent measures provide reassurance that it is attempting to protect American patients from contaminated drugs produced abroad. Read more »

One of the US Food and Drug Administration’s most important jobs is to provide the public with clear information about drug safety. Representative Joe Barton’s (R-TX) recent letter to the US Government Accountability Office (GAO) raises questions about whether FDA is telling us everything it knows. Read more »

The 2008 PDA/FDA conference opened this morning in Washington, DC, with keynote speaker and CDER’s top dog, Janet Woodcock. The theme of the plenary, “globalization through regulatory harmonization” is a must in today’s pharmaceutical industry.

“Heparin was a wakeup call,” demonstrating that we “need vigilance throughout the supply chain,” she explained. Woodcock added that solving these issues is “going to take a lot of harmonization” given the challenges present. Read more »

Many times innovation thrives in the wake of predicament. Earlier this year, the heparin-contamination issue sorely damaged consumers’ already delicate trust in the pharmaceutical industry but opened opportunities for several researchers to advance safer alternatives. Last week, at least two groups announced promising results toward this objective. Read more »

A second information request by Sen. Sherrod Brown (D-OH) of the Senate Committee on Health, Education, Labor and Pensions (HELP) on the outsourcing practices of a major pharmaceutical company—this time Merck & Co.—is moving the issue of outsourcing into an uncomfortable zone of political expediency versus constructive debate. Read more »