Two separate Congressional Committees heard testimony this week from FDA officials.  In both hearings the specter of Baxter's contaminated heparin loomed large.  Sadly, two years later the FDA has done nothing to control scofflaws like Baxter Healthcare and SPL from acting responsibly to control supply chains and track their products.
Baxter sourced its heparin in China but failed to control or even understand its supply chain.  Nor did it keep track of where the specific lots of contaminated heparin ended up.
Both of these issues came before Congress this week.

The hearing in the House of Representatives was held before the House Committee on Energy and Commerce. The opening statement of Chairman Henry Waxman deserves wider attention:

  We cannot forget the lessons of the 2007 heparin contamination catastrophe which resulted in numerous severe allergic reactions and the deaths of at least 80 Americans. In that case, the active ingredient was manufactured in China. Thanks to the excellent work of the Subcommittee on Oversight and Investigations in 2008, we know that this is not a unique situation: the U.S. drug supply is increasingly sourced from abroad.
  In order to market a drug in the U.S., FDA must ensure that the drug meets our appropriately high safety standards. So when ingredients or finished drug products are manufactured abroad, FDA needs to expand its reach if the Agency is to meet its responsibilities.
   As heparin illustrated, FDA clearly needs more authorities and more resources to do a better job policing the safety of imported products. But what heparin also demonstrated is that we cannot expect FDA alone to do this job. We need to place a greater onus on all manufacturers to oversee the safety of their own products. ...

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I hope FDA will tell us today about what the Agency believes it needs to protect us from another heparin disaster.

So what did the FDA state?  Joshua M. Sharfstein, M.D., Principal Deputy Commissioner for the FDA provided the agency's testimony.  While the FDA has opened more offices overseas and intends to institute a trace program to identify the location of prescription drugs, these steps appear to me to be more about helping big pharma make more money than patient safety.

Here is what the Pugh Prescription Project had to say about the hearing:

Two years after dozens of Americans lost their lives to contaminated heparin, we are still not able to protect U.S. consumers from many of the risks of pharmaceuticals manufactured in foreign factories. It is time for Congress to take action to better protect health. FDA must be given the tools it needs to protect our drug supply, which enters the home of nearly every American each day. Congress is right to focus on this important issue and today's drug safety hearing is a step in the right direction.

The FDA has received reports of 149 Americans who died after receiving heparin, all of whom suffered one or more symptoms associated with a known contaminant. The deaths occurred over a 17-month period in 2007 and 2008. Heparin, a blood thinner contaminated during manufacture in China, is an example of the movement of pharmaceutical manufacturing to the developing world and the increased risk that American consumers will be exposed to sub-standard and harmful drugs. A 2007 report by the U.S. Government Accountability Office estimated that 80 percent of the active ingredients in U.S. drugs are now made overseas, and that FDA has little ability to inspect foreign manufacturing sites. Health and Human Services Secretary Kathleen Sebelius and FDA Commissioner Margaret Hamburg have both said that the agency needs additional authority and resources to protect Americans.

The Senate hearing was before U.S. Senator Herb Kohl.  Senator Kohl held a hearing on the Food and Drug Administration (FDA) budget and heard testimony from FDA Commissioner Dr. Margaret Hamburg about the agency’s priorities for the next fiscal year. Kohl is the chairman of the Senate Agriculture Appropriations Subcommittee which has jurisdiction over funding for the FDA.
The FDA claimed it plans to provide increased protection for patient safety, increases are proposed to improve the safety of imports and high-risk products, expand partnerships with public and private entities, and to slightly increase FDA’s capacity to review generic drug applications.  The increased costs will come from taxpayers of course.
Why should taxpayers pay the addtional costs to inspect foreign based factories set up overseas by companies like Baxter and SPL who are trying to make more profits by flying under the regulatory radar and using cheap products?  I submit that the costs of inspecting these foreign operations ought to be born by the companies who import these drugs.  Simply impose a tax on imports to finance the costs of inspections overseas.  Taxpayers could continue to fund the costs of domestic inspections.  This would protect U.S. jobs and place the costs where they belong.

Similarly, the FDA and Congress should require each manufacturer to bear the cost of tracking the end use of each product it manufactures.  This is simply good safe distribution practice.  While we will be able to painstakingly prove that the contaminated heparin ultimately was distributed to each of the facilities where so many patients became ill and many died, for purposes of prompt recall and patient safety manufacturers like Baxter ought to be required to trace each lot to the end user.

Labels: Baxter, Baxter Heparin, contaminated heparin, FDA, foreign drugs, Heparin, Waxman.