Heparin at the Center of the Storm

July/August 2008, Vol 1, No 6 - FDA Approvals
Mark Senak, JD
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This past April has seen nothing less than a tug of war between Congress and the US Food and Drug Administration (FDA). During April and May, FDA staffers have been on Capitol Hill to offer testimony to Congress no less than 10 times. During the entire duration of 2006, the FDA only offered 12 testimonies. Congressional scrutiny of the agency has obviously increased in the past 2 years.

Although this Capitol Hill activity has involved many issues, the 2 that emerge as the most relevant—safety and funding—are related and were sparked by the problem of contaminated heparin. In fact, during April, matters related to the heparin contamination dominated the attention of Capitol Hill and the FDA.

Beginning in February 2008, Baxter Healthcare Corporation initiated a recall of all of its heparin products because of reports of serious adverse events in patients using that drug. It was found that the blood thinner heparin had been contaminated by inferior products that were used by some manufacturers, and the problem was occurring globally. As many as 81 people died after large injections of the product. Heparin was manufactured by multiple suppliers in China, and it is not known where in the supply chain the contamination may have occurred.1

An arch theme is connected with this episode of a contaminated pharmaceutical product. It must be determined how the contamination occurred (and the FDA and Baxter have offered the theory that the contamination was intentional),2 but the bigger issue involves questions related to the safety of the current system of drug manufacturing, and what can be done in today's real-world system to minimize the risk of drug contamination. On April 29, Dr Woodcock, Director of the Center for Drug Evaluation and Research, told the Subcommittee on Oversight and Investigations Committee on Energy and Commerce, "While the contaminant was first identified in the US, the recall of this product is international in scope. The FDA has notified key regulatory international partners, and we are working closely with our Chinese and European counterparts in the investigation."2

The events surrounding heparin have raised a host of issues for the FDA and paved the way for realizations about the very global nature of drug manufacturing. The heparin incident has made people realize that the components of many—if not most—drugs are produced outside of the United States, where the FDA has a very limited ability to inspect the manufacturing process.

This fact further undermines the argument that drugs cannot be imported because of safety concerns, when, in fact, drugs that are manufactured here are found to be unsafe. Perhaps most important to the heparin issue is the means by which we come to understand the weaknesses in the current system, and this is a metaphor for the fact that our ability to regulate safety is far behind the current trends of globalization—whether concerning food or drugs.

The heparin incidence has been at least partly responsible for a number of hearings on Capitol Hill. The first focus was on why heparin was contaminated, and whether the FDA was doing its job correctly. The secondary focus became one of how to fix the FDA so that the risk from such occurrences is minimized. This led at one point to a heated exchange between Congressman John Dingell, Chair of the House Committee on Energy and Commerce, and FDA Commissioner Andrew C. von Eshenbach during a recent congressional hearing. The commissioner was repeatedly grilled over whether the agency was doing its job correctly, and, more to the point, what funding measures would be needed to ensure that the FDA is in a stronger position when it comes to the inspection of foreign manufacturers.

The fact is, the amount of resources that would be required for the FDA to inspect each and every foreign manufacturer of every component of a medication is quite high. At question—which was unanswered in these hearings and exchanges—is whether it is reasonable to expect the FDA to successfully minimize risk abroad through a program of foreign inspections, or whether there is a greater role for manufacturers in ensuring quality.

In the case of heparin, even if testing had been conducted at the border, it is unlikely that the contamination would have come to light.

There is a need for a deeper inspection and analysis of the heparin contamination issue to determine whether funding for a more aggressive inspection program is in fact going to solve the problem that Congress and the FDA are facing. Heparin contamination is the symptom of a larger problem facing all drug manufacturing today, and unless it is addressed with a more comprehensive approach, history may be poised to repeat itself.
 

References

  1. FDA media briefing on heparin, April 21, 2008. http://www.fda.gov/bbs/transcripts/2008/heparin_transcript_042108.pdf. Accessed May 27, 2008.
  2. Woodcock J. US Food and Drug Administration. Testimonial before Subcommittee on Oversight and Investigations Committee on Energy and Commerce. Ongoing heparin investigation. April 29, 2008. http://www.fda.gov/ola/2008/heparin042908.html. Accessed May 17, 2008.
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