Is Origin Information for APIs Good for the Pharmaceutical Industry?
A recent Wall Street Journal blog post, “The Problem with Drug Provenance,” broached an interesting debate on whether the origin of ingredients in a drug should be listed as part of the drug’s product information.
The public and industry discourse on monitoring the safety of pharmaceutical ingredients is high following the case of contaminated heparin from China (see ePT story, “FDA Clarifies its Role in Heparin Investigation”). The heparin incident was the latest in a series of developments in which the US Food and Drug Administration’s ability and resources to effectively enforce good manufacturing practices from foreign drug-manufacturing facilities has been put into question.
Industry groups such as the Synthetic Organic Chemical Manufacturers Association and the European Fine Chemicals Group, which represent batch, custom, and fine chemical manufacturers, have been vocal critics over what they say is uneven and infrequent inspections by US and European regulatory authorities of foreign producers of pharmaceutical ingredients (see ePT story, “EFCG and SOCMA Urge More Inspections of Foreign API Makers”).
More funding to increase the number and frequency of foreign inspections is an obvious solution, but a difficult one given continual budgetary limitations of FDA and European national regulatory agencies.
Instead, would greater transparency in the pharmaceutical supply chain be the answer? As with any consumer product, the country of origin in which the product is manufactured is identified. Should the same practice be followed with active pharmaceutical ingredients (APIs)?
More than 80% of the APIs that go into drugs come from abroad, and India and China account for almost half of those imports, according to testimony from Rep. Bart Stupak (D-MI), chairman of the House Subcommittee on Oversight and Investigations, who spoke on the issue last November. He said that India’s pharmaceutical imports into the US increased 2400% from 1996 to 2006, making it the fastest-growing drug importer, and China has doubled its pharmaceutical exports to the US over the last five years (see ePT story, “Congress Focuses on FDA Inspections of Foreign Drug Facilities”).
There is no substitute for inspecting drug-manufacturing facilities, but until regulatory practices can be aligned with manufacturing activity, let consumers decide if the origin of APIs affects their purchasing decisions. Public disclosure may be the greatest equalizer in this debate and obligate pharmaceutical companies to reevaluate their supply chain.
We can have two or more opinions on any subject. It is comes down to “how I can make money.” SOCMA and EFCG have complained about Indian and Chinese companies but their members have NOW started to own facilities in the countries where they have complained that FDA has not done inspections.
Interestingly Major Pharmaceuticals have no problem and/or concern in getting products from China and India. Since they are responsible Corporate Citizens, everyone would expect they are behaving responsibly. However, in the case of Heparin, it did not happen. Greed took over and adulteration happened. I looked at the NMR posted by FDA and there are differences between good and bad. Someone at Baxter dropped the ball. We expect FDA to cure all the manufacturing ills. My question is where is Corporate responsibility, what happened.
Anything goes wrong, FDA get the blame. They are short of money and people. May be they should do the same thing FAA has done with American Airlines. We have inefficient processes run by 100 year old processes that are being monitored for quality (quality by analysis), we are lucky we have not had many more casualties. I am sure having the RIGHT process to deliver Quality by Design, much of the complaining would disappear.
This appears to be another simplistic approach to a complex problem and I see minimal value in listing Country of Origin since this can add no real substance to knowledge of actual manufacturing site quality. Ultimately it is responsibility of Sponsor Company to assure supply chain when they make those choices so must work with and build trust to get the quality desired and there have been way too many high profile failures. Major Pharma does source from China and India but think is with concerns and (hopefully) appropriate control systems.
There is a bit of an uneven playing field (although shrinking fast) however is there tolerance for passing along premium prices when can get adequate quality at a dramatically lower cost. The big push against high prices flows back on limited resources at companies and FDA. There is need for improvements and focus should be on root causes not less relevant label displays.
In terms of Baxter Heparin my reading suggest NMR was not a routine test on material (since is very uncommon to use NMR in QC environment) so looks bad only after the fact. The crime appears sophisticated in using a close analog (which had to be prepared synthetically?) that would not be detected by normal means so would slip through to increase bulk weight. Sabotage is hard to account for in any normal situation.