In February 2008, the FDA announced that heparin, a blood thinning agent, was not going to be manufactured voluntarily by its U.S. manufacturer because of serious adverse events. The adverse events were tied by FDA to a contaminant discovered that was found in eleven different nations’ supply of heparin, tied to raw materials from China.
The FDA has been conducting an investigation of the drug, and Congress has been holding hearings over the FDA’s investigation and have delved into questions about how heparin came to cause these adverse events.
On May 12, reports surfaced int eh Wall Street Journal that ran under the headline – "FDA Withholds List of Chinese Manufacturers From Probe" that suggested that the FDA has been withholding information about Chinese manufacturers who develop components of heparin due to confidentiality agreements. While that may be technically true, the FDA has a side of the story not told by the headline.
On Friday, I was fortunate enough to sit down with Deb Autor, Director of Compliance for FDA Center for Drug Evaluation and Research. She has been a frequent spokesperson on the issues related to the heparin issue on the part of FDA. She explained the FDA point of view by answering three direct questions:
- Are there confidentiality agreements that have caused the FDA to fail from sharing information with Congress?
- What does the FDA have under control at this point?
- Is heparin safe now?
I sought this interview because I think that there are times when the agency has gotten beaten up for things it does not deserve and that it has become a political football in many circumstances. I’ve been a critic of the agency from time to time, but there is a story to tell. I thought Eye on FDA could give an opportunity to tell it.
Hope you enjoy the podcast.