The heparin pile-on has begun--but this time, the FDA is at the bottom, not the drugmaker. As Baxter analyzes product samples for impurities that might have caused 350 adverse reactions, including four deaths, Congress and other critics are pointing fingers at the watchdog agency. And the FDA itself admits that yes, it violated its own procedures in approving the drug for sale without inspecting the Chinese plant where its active ingredient was made. One key Congressional critic is even asking FDA chief Andrew von Eschenbach to step down.
Baxter, of course, isn't getting off scot free. Its internal investigation is squarely under the media spotlight. So far, the company has found some differences between problem heparin vials and controls, and some of the differing samples did come from China. But so far, said a company spokeswoman, "[I]t's unclear what the impact of these differences is."
Baxter also ID'd the supplier in question, which it had refused to do before. The API maker is Scientific Protein Laboratories, a Wisconsin company that makes bulk heparin at a Chinese factory and at another at HQ. SPL says both plants adhere to the same industry and FDA safeguards. The agency is prepping an inspection team to check out the Chinese plant, and Baxter plans to send its own investigators. But plant personnel know inspectors are coming. "We'll fully cooperate," said a quality-control manager at the Chinese plant.
The big question posed by lawmakers and consumer advocates alike: With most bulk drug ingredients made overseas now--and only 7 percent of foreign plants inspected a year--what else is falling though the cracks? Some even want lawmakers to bar Chinese-made pharma ingredients. "China is fundamentally incapable of safeguarding...safety and efficacy," one business ethicist told Pharmalot.
- check out the Los Angeles Times report
- see more on the FDA angle from the New York Times
- get the news on calls for the FDA boss's resignation in the LA Times
- read the article in the Wall Street Journal
- find the Q&A with an ethicist at Pharmalot