A Broken Agency: China And The FDA Safety Gap
6 CommentsBy Ed Silverman // November 2nd, 2008 // 11:10 am
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…
Anne
Gardiner Harris’ essay is very detailed and frightening. However, it is too late for me. My child was killed by an American drug, made in America, and the Bush-deregulated FDA, now championed by a man with gold cufflinks, has only asked for more funds because Congress finally worked up some outrage.
I can see non-Mandarin-speaking FDA staff stumbling around China now, not even able to find the factory they are supposed to inspect. But phrma is not worried, because if the Court rules their way tomorrow, the line item for killed/pay money out will be small.
Anne PME
Thank you for posting this Ed. It is encouraging to see that both sides of the aisle realize the importance of providing FDA oversight and enforcement with adequate resources.
I wish that I could agree that when the FDA finds a problem with a US plant, the field officers recomendations are given weight and/or implemented quickly. Under this administration, legal has more oversight so things can take longer to respond to. Perhaps it would be better to say that corrections may be implemented more quickly.
Hope that you enjoy your Sunday.
Anne
Rich
Anne - these inspections are for manufacturing problems - they don’t deal with the safety of the drug itself (assuming it is properly made). Safety inspections of manufacturing sites will never uncover the fact that a particular drug is dangerous. What they will uncover is companies selling shoe polish compressed into “anti-depression pills,” or diluted milk tainted with melamine (problems impossible for consumers to detect without an array of expensive lab equipment).
In the branded pharma industry serious manufacturing problems have been rare in the last 30 years. When you make $5 per pill it pays to spend the extra ten cents to avoid shutdowns due to inspection issues. In the generics industry manufacturing problems have tended to be more serious due to the extremely narrow margin. However, the recent price pressure has led to branded companies outsourcing much more extensively with large pressure to cut costs.
Sure, if pre-emption doesn’t become the law of the land you’ll have the comfort of being able to sue some major institution out of existance when they kill thousands of people with a tainted drug (fifteen years after the fact most likely by the time appeals run out). Granted, all the folks who profited from the scandal would have cashed out decades before and the people most impacted would be employees working on new drugs who probably were in college when the event happened. One less drug company will just reduce the rate that new medicines are discovered and make drugs more expensive (fewer companies = more negotiating power). With companies being as short-sighted as they are I doubt that the threat of lawsuits is going to make them less likely to release tainted drugs.
Wouldn’t it make more sense to issue licenses to facilities that manufacture sensitive products like food and drugs and require frequent re-inspection to maintain the license? License fees could easily pay for the cost of the necessary inspectors. An inspector would have the power to shut down a plant or bar imports immediately if necessary - rather than waiting until thousands of people have been poisoned and for the courts to sort everything out.
Anne PME
When you get to be a certain age they say that things start to happen. As I understand it, you need better and brighter lighting once you hit a certain age. In anticipation of this (and other undisclosed variables) I had new wall sconces put in over my dining room/workspace/meeting table. I also must confess that I found a set of to die for wall sconces that give off a lot of light and to top it all of, they were on sale!
In this case, the wall sconces seemed like the perfect solution b/c the bathroom lights are on the backside of the wall where the sconces are and the bathroom wall was damaged and needed repair, so putting a few more holes in it before patching things up made sense. I wasn’t sure about permits and codes, so I asked several different people who to contact. All of them gave me the same name. We have this woman named Marge who works in city planning and zoning. Marge makes sure that inspections and enforcement are carried out. If you have a question, you call Marge. She is polite but firm and knows how to get things done. If Marge has a question or concern, Marge calls you and lets you know. If you are smart, you’ll listen to what Marge says because even if you don’t like what she has to say, you know that she is just doing her job.
After reading the recent GAO report on FDA foreign inspection deficits and the Harris essay, It is ironic that Marge’s oversight and enforcement of the permiting and inspection process for my new wall sconces appears to be more rigorous and better organized than FDA’s licensing and inspection of foreign plants. I wish that I could vote to allow Marge to clean house at our state pharmacy board.
Although we’ve lost a large number of them, there are plenty of FDA career employees left who are like Marge…they take pride in their work and in keeping patients safe. I just wish that like Marge, they could pick up the phone and tell Gardner Harris, FDA legal, and certain members of congress what they think we should be doing in the face of outsourcing and globalization, and what they need from us to help them do their job of ensuring and enforcing USFDA standards in foreign countries.
Prabir Basu
The consumers have a right to know in which plant the pill that they are taking has been produced, whether it was inspected by the FDA or not, and what was the quality standard of that plant compared to an equivalent U.S. plant. If the consumers had a choice of buying a drug produced in a plant overseas with a quality rating of say 4 out of 10 and has never been inspected against a plant in the Western world which has been inspected several times with a quality rating of say 8 of 10, the consumer can then make an informed choice of which pill to buy.
Today, the only thing the consumer can trust is that the manufacturing process and the plant is being inspected by the FDA and so they assume that the product is safe. We now know that all the foreign plants do not get inspected by the FDA and even if the Congress provides more funding to the FDA, it is going to take years and a lot of the tax payers’ money to fund the FDA adequately so that they will have enough inspectors to inspect thoroughly all the foreign plants as they do for plants in the US or Europe. Why should the U.S. tax payer subsdise the drug companies so that they can get their products made abroad cheaper while making it unsafe for our consumers? The Congress should pass a law that until and unless the FDA is able to inspect thoroughly a foreign plant and provide a rating for its manufacturing quality, drugs or drug components made in that plant should not be allowed to be sold in the U.S. In addition, a drug company who wants products to be imported from abroad should pay for the cost of inspecting that plant and ensure that products made in that plant are safe. That way, the tax payers do not have to fund the inspection process. In the U.S. if a drug company submits an application for approval of a new drug, the company is not allowed to market the drug in the U.S. until the FDA does a complete inspection of their manufacturing facilities. Why should there be a different standard for foreign manufacturers? We are using tax payer dollars to inspect these foreign plants which could be used at home to invest in research in product development and manufacturing science to make our products cheaper and safer. That is a much better way to spend our tax dollars.
Rick
I often wonder why the US Government does nothing about the situation in China. How many lives will it cost before they act? Then I realized that with China holding over $700 B in US treasuries the government doesn’t have the guts to confront them for fear of China dumping securities and trashing the dollar. Regulatory authorities in the US have gone to sleep and have allowed foreign governments and large corporations rape the American people.