Ohio Senator Sherrod Brown struck a blow for victims of dirty Chinese Heparin yesterday in a speech in our nation's capital. Speaking before the Washington International Trade Association and the George Washington University Elliot School for International Relations, Senator Brown decried the importation of cheap drugs:

Our enormous trade deficit has resulted in our nation not only importing goods and services, but also importing the dangerous safety standards of our trading partners.
In Toledo, Ohio, patients died after taking contaminated Heparin to treat their heart conditions. The manufacturer of Heparin had outsourced the making of the drug, and as a result, did not know where the contamination occurred.
The patients in Toledo, or the factory workers in Reynosa, or the meatpackers in Nebraska illustrate that continuing our trade direction is not a ringing endorsement of our trade agenda. Their stories represent a continuation of a policy of broken promises. [Link to full text of speech]

I discussed the Heparin Disaster with Senator Brown last year in Toledo. He clearly heard the concerns of the victims of big pharma. Senator Brown understands that the big corporations like Baxter Healthcare put profits over people.

We have now received about one million pages of documents from Baxter. These documents show that Baxter went to China for its heparin because it could save a few dollars on its raw material costs. Baxter knew the Chinese facility had never been inspected by the FDA. It knew that there were no inspections being performed on the heparin workshops and consolidators.

Baxter showed reckless indifference even after the contamination was brought to light. We are now learning that Baxter was being criticized by the FDA in September of 2008 for an inadequate recall.

The more we learn, the worse the story. We will continue to uncover the unsavory details and fight in the courtroom for the victims. We ask you to all support Senator Brown as he fights for us in the halls of Congress.

Labels: Baxter, FDA, Heparin, Heparin Class Action, heparin lawsuit, Sherrod Brown

According to a recent article in the New York Times, "experts and lawmakers are growing more and more concerned that the nation is far too reliant on medicine from abroad, and they are calling for a law that would require that certain drugs be made or stockpiled in the United States." (Gardiner Harris, The New York Times 01/19/09 “Drug Making’s Move Abroad Stirs Concerns.”)

In recent years, pharmaceutical companies like Baxter (who sold the majority of contaminated heparin that resulted in numerous U.S. deaths), have imported drugs and/or shipped production oversees in order to increase corporate profit and avoid regulation. Of the 1,154 pharmaceutical plants mentioned in generic drug applications to the FDA in 2007, the article reports that only 13 percent were in the United States. Forty-three percent were in China, and 39 percent were in India.

The article further reports that since drug makers often view their supply chains as trade secrets, the true source of a drug’s ingredients can be difficult or impossible to discover. Indeed, the FDA cannot even identify how many foreign entities ship drugs into the U.S.

As a result, and as made clear from the recent heparin contamination, oversees drug production with little or no government oversight, leaves Americans at risk for tainted drugs. We continue to support Ohio Senator Sherrod Brown, (who has held hearings on this issue), and other lawmakers who remain dedicated to ensuring that America’s drug supply is safe.

Labels: Baxter, Baxter Heparin, China, FDA, Heparin, heparin attorney, heparin lawsuit, heparin lawyer, OSCS, Sherrod Brown

This week Ohio Senator Sherrod Brown sent a letter to the FDA challenging them to evaluate the level of outsourcing by U.S. Pharmaceutical companies, and the impact of that outsourcing on Drug Safety. He also asked Pfizer, who admitted outsourcing 17% of their API ("Active Pharmaceutical Ingredient"), to make public how much money they save by doing so. Sherrod Brown Press release and letters.

Now the FDA has announced that it will spend taxpayer money to set up inspection offices in China and India. (Three offices in China this year, followed by offices in India. Story here.) It seems to me that the drug companies that profit from overseas operations and the lax or total absence of controls and inspections should pay for these offices and the cost of inspecting the foreign operations.

Senator Brown is absolutely right to dig into this issue that is so critical to the health and safety of our citizens. As he stated to Janet Woodcock, head of the FDA:

You also asserted that FDA must have the tools to hold drug companies accountable when they outsource. What, in your opinion, is the best means of holding these drug companies accountable? All parties throughout the drug supply chain should be held accountable for the quality and integrity of the products they produce.

I seriously doubt that the current FDA will hold drug companies accountable. But they must do so. And those injured by the failure of the drug companies to perform their duties must be able to obtain full and fair compensation from the drug companies that have failed to provide products that are safe and effective.

Thank you Senator Brown. Please keep challenging the FDA, Pfizer, and the rest of the phamaceutical industry to do their duty. And please give those persons and families who are injured and killed the ability to seek full compensation. It is ridiculous to protect these companies from liability on the basis that the FDA is doing its job.

As we have seen in the Heparin Disaster, and as I pointed out in my blog yesterday, the Chinese operations, subcontractors and joint ventures of these drug companies are flying under the radar of the FDA. Even when the FDA tries to inspect these companies they cannot do so.

Labels: FDA, Heparin, heparin attorney, Heparin Class Action, heparin lawyer, nightline, Pfizer, Sherrod Brown