A Call for More Regulation

 In response to a recall of Heparin by Baxter healthcare, Dr. West at openitstrategies has uncharacteristically called for more regulation in response to the 19 reported deaths associated with another round of tainted products from China.  It may be that regulation is the solution, but I think there are probably adequate regulations in place.  I want to point out what may be a couple of problems that led to this tragedy:

Problem 1:

"But sophisticated tests by Baxter and the FDA, including nuclear magnetic resonance spectroscopy and capillary electrophoresis, showed slight differences."

I have to admit that some of this article reads like the author was shilling for Baxter.  Yes, by some standards these are "sophisticated" tests.  You wouldn't normally do them on your kitchen counter.  But I was doing NMR (nuclear magnetic resonance) in college a very long time ago.  Same with electrophoretic techniques.  Most newer drugs have these sorts of tests as part of their normal battery of tests.  Older drugs that are covered by the U.S. Pharmacopeia often are allowed to have older, less specific tests for identity and purity (two parameters which, as I recall, need to be evaluated for all active ingredients).  What would be nice is if the USP would update the testing standards for these items, and I don't think regulation is necessary for that.  Its been a while since I've been around the USP and worried about the update process.  I think it tends to be more reactive than proactive.  Regardless, the laws (FD&C Act) and regulations (21 CFR 211) require safety and purity.  Sticking with ancient assay techniques is no way to ensure safety.  We know that from not so distant history.  In fact, it is a standard requirement with newer drugs to have limits on unknown impurities - usually detected via things like Chromatography, Electrophoresis, NMR, or combination assays involving Mass Spectroscopy.  Any of these tests, if standard, would have identified the significant contamination levels in the Heparin supply.  At a previous employer, we routinely used Mass Spec as part of the release test for a drug that was still in development.  Owing to the complexity of the manufacturing process, and the ever increasing sensitivity of the tests, we were frequently discovering and identifying new impurities.  I don't see why similar behaviors shouldn't be the norm even for older, more established drugs.  As Joel points out, its not like Baxter doesn't have the profit margin to support some additional testing.

That leads us to Problem 2:

"The news is good for Baxter as a company, says Aaron Vaughn at investment firm Edward Jones.

'Originally, it was a Baxter story. Now, it's become China supplying the U.S. market with goods that are not up to international standards,' he says."

Umm, no.  Quiz time.  Baxter sells a drug on the U.S. Market.  Question:  Who is ultimately responsible, under the FD&C act, for ensuring that the drug is safe, efficacious, and unadulterated?

Class?

Yes!  Baxter.  No ifs, ands or buts.  I don't care who gave them the raw materials, I don't care where they came from.  I don't care if the FDA was asleep at the switch somewhere.  Everybody in the Pharmaceutical Quality business knows that its Baxter's problem.  What kind of agreements did they have with their supplier?  Didn't they need to be informed if the source of the raw materials were being changed?  What sorts of auditing programs were in place to ensure the ongoing quality of the manufacturing process of the raw material (which is really an active ingredient, which enhances the level of scrutiny Baxter should give it)?  These don't need to be regulated because they already are.  The FDA should subject Baxter to a serious inspection, and ask some serious questions.  I think there will be some significant changes at Baxter over this one - but the changes won't be in response to new regulations, they will be in response to the FDA demanding they adhere more to the ones on the books.

As noted above, it is illegal (a felony, actually) to introduce a drug into interstate commerce which is either adulterated or misbranded.  This heparin was clearly adulterated.  Baxter introduced it into interstate commerce.  The story, and the buck, stops there.