U.S. FDA failed to inspect a Chinese API manufacturer that may be linked to a recent heparin safety scare because the wrong Chinese firm was entered into an agency database, a compliance official said Feb. 18.

Speaking during a press briefing, FDA Center for Drug Research and Evaluation Deputy Director for Compliance Joseph Famulare said that, "When this site was named in the [NDA] application, the firm that was selected and sent to the Office of Compliance for evaluation was not the correct firm."

"It was another firm with a similar name. We therefore evaluated the firm with the similar name, which had an 'in compliance' recent inspection history. Therefore, this particular firm was not put forward for evaluation."

According to Famulare, FDA has since reviewed its internal process and "not discovered any other firms in this category, and to date this is an isolated situation. The wrong firm was put into the database, and therefore this one was not evaluated for inspection."

FDA now has ongoing inspections in the U.S. at both Baxter Healthcare, which manufactures the heparin, and Wisconsin-based Scientific Protein Laboratories, Baxter's API supplier. The agency also has launched a "comprehensive inspection" of SPL's China plant, according to Division of Field Investigations Director Michael Rogers.

At this point, the agency does not "know the cause of the problem," Rogers told reporters.

By policy, FDA is supposed to pre-inspect API manufacturers referenced in an NDA application prior to approval. If the facility was inspected recently by FDA, then the inspection may be referenced in another application without requiring an additional physical inspection, Famulare noted.

He also confirmed that China's State FDA does not generally inspect companies that manufacture ingredients only for export (Also see "Chinese Heparin API Manufacturer Not Inspected By SFDA" - Scrip, 18 February, 2008.).

Competing Heparin Product Could Benefit

FDA said Feb. 11 that it had received roughly 350 adverse event reports since December 2007 related to Baxter's heparin, leading the company to suspend manufacturing of multiple-dose vials of its blood thinner. Baxter supplies roughly half of the heparin to the U.S. market (Also see "U.S. FDA’s Response To Heparin Scare Made With “Alacrity And Sound Judgment” – von Eschenbach" - Scrip, 18 February, 2008.).

One company that could benefit from the safety scare is American Pharmaceutical Partners, the other supplier of heparin to the U.S. market. FDA has advised doctors to switch from Baxter's heparin to APP's heparin, where available.

APP, which also sources its heparin from China, uses a different plant that passed an FDA preapproval inspection, Famulare said during the conference call.

In a Feb. 19 note to investors, Oppenheimer analyst Elliot Wilbur said that he expected to see a near-term revenue boost for APP, but that much of that gain has already been reflected in the company's stock. Wilbur expects APP "to keep some of [Baxter's] current loss heparin business, say 15%-20%, far less than the near best-case scenario implied by the 12% move in shares since the heparin news first broke."

- Joshua Berlin (j.berlin@elsevier.com)

[Editor's note: Look for additional coverage of this developing story in upcoming issues of PharmAsia News.]

U.S. FDA Inspected “Wrong” Heparin API Manufacturer – Compliance Official

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