Earlier this week Grassley, who since 2007 has twice filed legislation seeking to “beef up” the FDA’s foreign inspection operation, sent a letter to the federal agency seeking a progress report on improvements to inspections.
Here is the senator’s press release on the matter, and the full text of his letter.
http://www.iowapolitics.com/index.iml?Article=185684
In seeking a follow-up, Grassley is essentially trying to hold the FDA’s feet to the fire for commitments it made when Baxter International temporarily suspended production of its blood thinner heparin in 2008 because of adverse reactions.
“My letter today follows up on oversight I did at that time because requirements the FDA already had in place then were not met by the FDA, and the drug company itself didn’t have a system to check the quality of upstream providers of the drug components,” Grassley said in statement. “In fact, pharmaceutical companies aren’t required to have those checks in place.”
That is terrifying information for anyone who takes medication in this country.
“I will continue asking the FDA for information and working to hold the federal agency accountable in its work to protect the safety of the drugs in our medicine cabinets,” Grassley said.
His proposed legislation calls for the enhanced enforcement for quality and safety violations. But the bills, which Grassley had introduced with the late Sen. Ted Kennedy (D-Mass), hasn’t been passed by Congress.
As many of our readers will know, Grassley is one of the chief Republican obstacles to the passage of health care reform. The irony of that contrasted against his outrage with Heparin is a bit much.
Grassley’s press release noted that China is one of the largest exporters of pharmaceutical products to the United States. Following questions raised by him others in 2007 and 2008 about the inadequate foreign inspections, the FDA has opened an office in China to facilitate inspections.
Dow Jones wrote a story on Grassley’s call for answers and an update from the FDA.
http://www.nasdaq.com/aspx/stock-market-news-story.aspx?storyid=201002161801dowjonesdjonline000426&title;=sengrassley-asks-fda-about-monitoring-of-drugs-made-abroad
That article says that 80 deaths were blamed on contaminated heparin, a blood thinner, from China. Based on the number of wrongful death claims that have been filed against Baxter, that number may be seriously understated. The contaminant, oversulfated chondroitin sulfate, OSCS, was in the heparin that Baxter received from is supplier Chanzghou SPL. Chanzghou SPL is a subsidiary of a Wisconsin company, SPL.
Grassley wants the FDA to answer his letter by March 2.
Don’t expect too much. While Grassley’s position is laudable, more should be done by Congress to get a full accounting of just how many people Baxter and SPL killed.
Congress should be publicly asking these questions of all of the heparin players, not just the FDA:
- How many wrongful death claims has Baxter received?
- How many doses of the contaminated heparin were actually given to people?
- Why didn’t Baxter react more quickly when it learned of the deaths?
- Why didn’t Baxter have some type of tracking system on its products so that when it learned of the contamination, it could quickly pull all of the tainted product from its shelf?
- Why wasn’t the FDA and Baxter more concerned about the risk of counterfeiting drugs?
