Yesterday the FDA announced that it identified the contaminant found in the recalled Bayer product heparin, a China-made blood thinner derived from pig intestines: oversulfated condroitin sulfate, a chemical that does not occur naturally, CNN reported.
Bayer issued a full-scale recall late last month, after 19 people died and over 700 more suffered from the product’s adverse reactions. The FDA says it’s unclear whether the chemical is directly linked to the heparin deaths and side effects.
The NY Times reported that the Chinese heparin market has been in turmoil over the last year. The Chinese heparin plant under investigation may have used crude heparin from unregulated family workshops. Heparin is made from scraped pig intestines.
The FDA wants you to feel safe now: “Doctors and patients now can be confident that the product on the market has been tested and is safe,” said Janet Woodcock, head of the FDA’s Center for Drug Evaluation and Research. But the market conditions creating the situation haven’t changed and the FDA violated its own policies.
The FDA admitted its violation when it said it failed to inspect the Chinese plant, which sparked a broader discussion of the FDA’s shortcomings in light of foreign drug inspections. Out of 566 Chinese drug plants that export to the U.S., the FDA only inspected 13 last year.
Julie Zawisza, FDA spokeswoman, said the agency was “looking at a number of options in addition to more foreign inspections to increase our presence abroad and our ability to detect problems.” They now say they will open an office in China to conduct audits and inspections.
But for these foreign inspections to occur, some lawmakers like Rep. Bart Stupak (MI) say the agency needs more funding, which may require taking drug company user fees.
Why should the taxpayer pay for these inspections so that you can close a plant here and open it over there to ship it back? It will be sustainable income so that we don’t have to get into these budget battles every year, said Stupak.
While the FDA investigates whether or not the heparin was contaminated intentionally, it’s understandable that heparin users (millions of people) might be nervous about taking the medication.