FDA and Heparin Inspections

Posted on 6th March 2009 by gjohnson in Uncategorized

anaphylactic heparin reaction, Baxter, Baxter recall of heparin, drug counterfeiting, FDA recall of Heparin, hemodialysis allergic reactions

Yesterday, I railed against the FDA’s increasing inability to assure that our drug supply is pure. Earlier this week, our blogs quoted a familiar name, Janet Woodcock, about some of those same failings. Woodcock should be a familiar name to those who have followed the Heparin Catastrophe. It was Woodcock who last year testified to Congress about foreign inspections, the in wake of first reports of Heparin deaths.

Last year, Woodcock explained the new and improved approach of the FDA to Congress as follows:

FDA conducted more foreign inspections in Fiscal Year (FY) 2007 than any other in the Agency’s history. For example, in FY 2007, FDA conducted 332 inspections of foreign drug manufacturers, compared to 260 in FY 2004, 266 in FY 2005, and 212 in FY 2006. We plan to conduct 500 in FY 2009. While, inspections are an important component of the Agency’s systematic approach to ensuring the safety of imported medical products, they alone cannot fully address these challenges.

Beyond Our Borders Initiative. The FDA Beyond Our Borders Initiative is a multi-pronged approach to promote and verify compliance of imported food, cosmetics, and medical products with FDA requirements. This Initiative includes increased FDA presence in China, increased FDA inspections, greater sharing and use of foreign competent authority inspection reports and other information, use of third party certification, and increased capacity building with countries that have less developed regulatory systems to ensure product safety.

Foreign Presence. China is one of the largest exporters of drug products for the U.S. market. Recently, FDA and HHS leadership, the Department of State, and the U.S. Ambassador to China committed to establishing an FDA office in China this year. On March 8, 2008, the Department of State approved FDA to place 13 total staff in China (eight FDA personnel and five Foreign Nationals). This staff will be responsible for building closer working relationships with our Chinese counterparts, carrying out inspections, and working with Chinese inspectors to provide training. FDA is in the process of making the necessary arrangements and preparing to hire staff. This effort builds on two recently-signed Memoranda of Agreements (MOA) with two Chinese FDA counterpart agencies that facilitate broader access to Chinese production facilities on an expedited basis. This is a significant step toward ensuring the safety and efficacy of medical products produced for the U.S. market.

FDA’s efforts will build stronger cooperative relationships with counterpart agencies in China, enhance technical cooperation with these agencies, and foster the flow of information between regulatory systems. Having an overseas presence in China will improve our ability to inspect facilities in China and, very importantly, foster greater interactions between FDA staff and Chinese manufacturers to help ensure that products shipped to the U.S. meet FDA standards for safety and manufacturing quality. In addition, FDA is working to establish beneficial collaborations with India, another large exporter of drug products to the U.S.

Well, the Heparin Catastrophe demonstrates how flawed the FDA’s approach has been. Eight American inspectors for all of China? The goal is to increase inspections from 300 to 500? That is like having 500 auditors for the entire IRS. And I wonder how many of those eight people will speak Chinese?

The Congressional hearings told about the horrors of Chinese drug facilities, just in terms of basic things like cleanliness, not even to mention sterility. Hopefully, massive increases in inspections will at least address those concerns. What good is it for doctors to wash their hands if the drugs they give aren’t sterile?

But the biggest problem the FDA faces is purity. While that sounds like the same thing, I refer to the sterility issue as assuring that bacteria or viruses don’t contaminate drugs. By purity, I mean that the drugs are diluted by a substance that is put in there to dilute the drug, by using cutting agents that are being cleverly disguised to look like the real thing, such as with OSCS and Heparin. The problem with the cutting agents that are disguised to look like the real thing is that these compounds are not innocuous like sugar,. They are in fact complex organic compounds that may have very complex and poorly understood consequences.

But just imagine that the cutting agent was as innocuous as sugar. Well, that would be fine if you weren’t giving it to a diabetic. The problem with any cutting agent is you don’t know who will be hypersensitive to it. The FDA can impose all of the stringent trial and research requirements it wants before approving a drug, but if what is actually sold under that label, isn’t pure, it is a disaster.

You are not going to catch clever counterfeiters with inspections. This type of misconduct can only be detected by rigorous and ever more vigilant testing for purity. It may never be practical to catch each new and progressively more clever attempt to dilute the purity of drugs. Which is why we should not allow any drug to be imported. But if that is too protectionist for the free marketers, and our global trading partners, then at a minimum we must ban the importation of drugs used for intravenous or other sterile administration.

As all Baxter does, according to its Chairman Robert Parkinson is, “manufacture products that are injected or infused or inhaled by patients who need them to stay alive,” Baxter should never have imported any part of what it sells. Baxter should begin its reparations for poisoning Americans by leading the U.S. drug industry towards this type of protectionism – protecting the American patient.