Chinese Puzzle - Pharmaceutical Executive

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Chinese Puzzle


Pharmaceutical Executive


Inspection: The Impossible Mission

When SFDA announced on March 19 that China was to blame for the heparin contamination, it answered certain outstanding questions for anyone who'd been following the story.

But the most remarkable aspect of the announcement was its very occurrence. Any attempts at a cover-up seemed to have been dropped. Instead, one day after the New York Times beat FDA to the punch by identifying the contaminant and indicating that counterfeiting was the probable cause, the Chinese agency publicly took responsibility. The press conference was attended by a throng of Chinese and foreign reporters—and were even permitted to ask questions! The appearance of transparency was a revelation.

If SFDA scored points for openness late in the game, the US FDA mostly suffered from its own efforts at openness. Perhaps the worst hit came when FDA reported that contrary to its own rules, it had OK'd the Chinese plant without any FDA inspector ever having set foot in it. Agency officials did, in fact, visit a Chinese plant, but it was the wrong one—confusion over the similar-sounding names.

Licensing a factory that it had never inspected—and that now was a key link in a supply chain scandal—put FDA in the stocks. A very public blame game followed. The House Energy and Commerce subcommittee on Oversight and Investigation fired off angry letters and scheduled yet another FDA hearing. The media and the blogosphere piled on, pointing fingers alternately at FDA, Baxter, and the Chinese plant, SPL. However, the New York Times and the Wall Street Journal, in particular, distinguished themselves with aggressive investigations that did far more than any other source to discover the real story. In this context, FDA, Baxter, and SPL said as little as possible—not an approach to inspire confidence.

Suddenly, FDA's capacity to inspect foreign drug firms was a burning issue. Both the General Accounting Office and FDA's Science Committee had issued recent reports on the subject arriving at the same conclusion: The agency was so absurdly short of staff and resources that it had, for example, inspected only 7 percent of the 3,249 foreign drug manufacturers by the end of 2006. At that rate, FDA would need 48 years to inspect each plant just once. Faced with this impossible mission, the agency had developed a risk-based priority list for inspections. Yet priorities were not always clear. Over the past five years, FDA has inspected half of India's 299 plants making drug for US import, compared with about 12 percent of China's.

But in reality, staff and resources are consumed by the mandate to inspect plants as part of the NDA approval process, leaving little capacity for post-approval inspections. "If you haven't been in a plant for the last two or three years, you don't have any clue what's going on," said a congressional source familiar with investigative work into the FDA. "They could be running monster truck rallies on the plant floor, and we wouldn't know about it."

SFDA, meanwhile, moved to wash its hands of accountability. The agency announced that foreign-owned plants manufacturing drug materials for foreign import were entirely responsible for ensuring their legality, quality, and safety. This not-my-problem policy, SFDA claimed, conformed to international practice. But Natasha Leskovsek begs to differ. "It is certainly not prevailing practice for the home government to tolerate the making of unsafe products for export," she says. "By responding this way, SFDA is raising questions about the quality of their manufacturing—and threatening business." Later the agency backpedaled, pledging to help safeguard supply chains, she added.

Sheldon Bradshaw saw SFDA's announcement less as skirting responsibility than as an awkward move to preempt any finger pointing. "The Chinese are very image conscious, particularly with their hosting the Olympics," says Bradshaw. "They were going to pains to point out that this was not their screw-up."


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