Citing FDA ‘Missteps,’ Congressmen Want Answers To ‘Unsolved Heparin Whodunnit’

Posted on 5th May 2010 by gjohnson in Uncategorized

Dr. Margaret Hamburg, FDA, heparin, heparin contamination, House Energy and Commerce Committee, probe of FDA handling of heparin, Rep. Joe Barton and heparin, Rep. Michael Burgess

Last week The Wall Street Journal leaked the contents of a blistering letter that two congressmen wrote to the Food and Drug Administration over the agency’s handling of a probe into the exact source of contaminated heparin from China, deadly blood thinner that was linked to hundreds of deaths in 2008.

The House Energy and Commerce Committee Republicans put out a press release about the heparin matter last Friday. http://republicans.energycommerce.house.gov/news/PRArticle.aspx?NewsID=7832

And that press release includes a link to a copy of the letter.

U.S. Reps. Joe Barton, R-Texas, ranking member on the House Energy and Commerce Committee, and Michael Burgess, R-Texas, ranking member of the panel’s Oversight and Investigations subcommittee, didn’t mince words with FDA Commissioner Dr. Margaret Hamburg.

The headline on their press release alone was “Barton, Burgess Reveal FDA Missteps in Unsolved Heparin Whodunnit.”

Then in their 10-page letter, the two lawmakers detailed what their investigation into the heparin tragedy has discovered, basically accusing the FDA of dropping the ball when it didn’t follow up on leads linking Chongqing Imperial and other Chinese drug suppliers to lots of contaminated heparin identified during the 2008 recalls.

“We are very troubled by how FDA has handled the investigation to find out who was responsible for the contaminated heparin,” wrote Barton and Burgess. “The staff has learned that FDA has specific and credible information about certain Chinese heparin firms that warrants further investigation as suspect entities responsible for contaminating the heparin supply.”

Barton, an ardent watchdog on the heparin issue, and Burgess asked Hamburg to provide details about the agency’s strategy regarding the unresolved investigation. And they want to know the FDA plans to do when it identifies manufacturers responsible for producing the contaminated blood thinner.

“Unfortunately, the case of who contaminated the heparin remains unsolved,” the letters says of the tainted blood thinner that killed in 2008, resulting in hundreds of lawsuits.

Barton and Burgess want answers to seven questions from Hamburg by the end of May.

Those questions include:

1.    What is FDA’s strategy for solving the question of who caused the contamination of the heparin supply? Please detail the strategy and when it was developed, the names and positions of the FDA officials who developed the strategy, and the names and positions of the FDA officials responsible for implementing the strategy.

2.    To what extent can FDA conduct a traceability investigation of various heparin supply chains in China on its own without the assistance of the Chinese government?

3.    Assuming FDA could solve the case on its own, what would FDA do with this information?

4.    What actions is FDA taking to follow up on the Chongqing Imperial issues raised in this letter?

5.    Does the FDA agree there is a basis to make another request to the Chinese government about the heparin contamination investigation? If not, why not?

6.    Is the FDA willing to cooperate and even share information with the Chinese government in an effort to solve the heparin contamination case? Would FDA be able to do this under current law and under the current agreement with the SFDA (State Food and Drug Administration)? If not, why not?

7.    Does FDA agree that the contamination of the heparin supply is an international issue? If so, why hasn’t the FDA sought international support from the World Health Organization and/or other countries to get more transparency and cooperation from the Chinese government, or to provide assistance to the Chinese government, in the heparin contamination-source investigation?

It looks like Hamburg has her work cut out for her in the next few weeks.