- NHF members reside in these countries:
A Broken Agency: China And The FDA Safety Gap
By Pharmalot
November 02, 2008
In an essay that takes a top-down view of the agency and its myriad problems protecting the supply of pharmaceuticals, Gardiner Harris of The New York Times reviews the highlights - or lowlights - of the past year or so: the Heparin deaths, the Ranbaxy scandal and the withering criticism from Congress.
And he notes some of the issues bedeviling the FDA as it struggles to cope with the growing role played by Chinese suppliers: antiquated FDA computer systems, an inability among FDA staff to decipher names of Chinese plants, difficult travel conditions for agency inspectors, and, of course, the debate over sufficient FDA funding. For instance, this year, 18.2 million shipments of food, devices, cosmetics and drugs are expected to enter more than 300 US ports, but the FDA had 454 investigators in 2007 - one and a half per port to scrutinize them. Here are a few more key points…
“Last year, generic drug applications to the FDA listed 1,154 plants providing active pharmaceutical ingredients: 43 percent of them were in China, and another 39 percent were in India. Only 13 percent were in the US. Branded drug makers, with their fatter profit margins, resisted buying ingredients from China for years, but with their businesses now suffering, even major drugmakers like AstraZeneca, Bayer, Baxter and Pfizer have announced deals to outsource manufacturing to China…
“Even the FDA staunchest defenders now acknowledge that something is terribly wrong. Among them is Peter Barton Hutt, who served as the agency’s general counsel during the Nixon administration and is widely considered the dean of the FDA bar in Washington…has always defended the F.D.A. No more. ‘This is a fundamentally broken agency,’ Hutt tells him, ‘and it needs to be repaired.’
“To ensure the safety of imported drugs, the FDA relies almost entirely on its own inspections of foreign plants. This was not much of a problem 30 years ago, when most medical products consumed in the US were made here and FDA inspectors could drive around to plants in their district. Most of those plants have since moved abroad, and now decades can pass between inspections. Testifying before Congress in April, Janet Woodcock, who heads the FDA’s drug center, spoke with rare frankness about the ability of the agency to do its job abroad. ‘The FDA of the last century is not configured to regulate this century’s globalized pharmaceutical industry,’ she testified…
“Tim Wells, who was a field investigator and then a compliance officer for 24 years at the F.D.A., now does private audits of drug plants and sees the holes in the agency’s safety net. “A company I recently visited abroad hasn’t been inspected for 10 years,’ he tells him…
“Besides being more frequent, domestic inspections are unannounced and more intense. And when inspectors find dangerous conditions at domestic plants, they generally return promptly to ensure that those conditions get fixed. Not so in foreign plants. In a report released last month, government auditors reported that between 2002 and 2007, FDA inspectors found dangerous conditions in 15 foreign plants. Only one of those plants was reinspected within two years, the auditors found. In every other case, the agency took foreign managers at their word that promised changes were made…
“The record is particularly bad in China. Over the past six years, the FDA has managed to inspect annually an average of just 15 of the 714 Chinese drug plants that export to the US. At its present pace, the FDA would need more than 50 years to visit all of these Chinese plants. By contrast, the FDA inspects domestic drug plants every 2.7 years...
