In their latest clash with the FDA over the four-year-old heparin scandal, several Republicans on the House Energy and Commerce Committee have blasted the agency for failing to pursue a pair of so-called workshops in China that allegedly sold tainted supplies that led to more than 80 deaths in the US back in 2007 and 2008 (back story).
In a letter sent yesterday to FDA commish Margaret Hamburg, the congressmen maintain the agency possesses "credible evidence" that at least two Chinese suppliers sold heparin that was contaminated with oversulfated chondroitin sulfate to Scientific Protein Laboratories which, in turn, supplied Baxter Laboratories. Moreover, they charge that the same two Chinese suppliers not only sold contaminated heparin, which is made from pig intestines, to other companies, but continue to supply product that is being imported into the US.
Here is where the fuming begins. Despite this, the congressman maintain they have seen "no indication" that the FDA has issued warning letters or import alerts to Chinese suppliers. Yet, the agency supposedly learned the identity of at least one of the workshops that was linked to the scandal. but has not taken any action to investigate or alert drugmakers not to purchase from these workshops.
"We are trying to understand FDA's enforcement policy regarding Chinese firms implicated by industry sources as suppliers of contaminated heparin," they write, before asking Hamburg why certain steps have not been taken. The letter, which you can read here, was signed by by committee chair Fred Upton and chairman emeritus Joe Barton, who has been railing at the FDA for the past few years.
Earlier this year, FDA official John Taylor told a Pew Health Group conference in Washington, DC, that supply chain issues remain irksome and acknowledged that “another public health crisis like Heparin seems inevitable" (see this). We have asked the FDA for comment and will update you accordingly.
[UPDATE: At 4:30 pm ET, the FDA sent us this: "The FDA will be responding directly to Chairman Upton and the other signatories of the letter regarding the issues they raise; however, it is important to note that we do not believe there is a public health risk related to heparin produced for the US market. We welcome the opportunity for continued dialogue and information sharing with the committee on this matter."]
5 Comments
"We have asked the FDA for comment and will update you accordingly"
...I wouldnt hole my breath on that...
...the real issue is pharma companies with such poor procurement competencies that they can't properly select suppliers and detect adulterated materials when they are delivered to them. Knocking the FDA won't cure that - it's like blaming crime on the police.
Maybe it is a case of two wrongs not making a right?
FDA jusrisdiction in China is more limited. However, pharmacuetical companies should realize this and budget this factor accordingly.
The letter the Republicans at E & C sent also might bring up new questions about whether or not the FDA should have drug recall authority.
Joe Barton has no credibility when it comes to criticizing FDA. In the 1990s, he was part of Newt Gingrich's monkey trials in which astroturf "patient advocacy groups" gave "testimony" about the life-saving drugs that FDA was keeping from them.
All of it collapsed in a puddle of demonstrable misinformation. Upton, from my state, is in the same league.
Whatever the real issues (and FDA funding is certainly one), this appears to be more political horse hockey.