The FDA has also stepped up its efforts to stem the supply of substandard drugs that is plaguing developing countries in hopes it will also improve the drug supply chain in the U.S. Last month, the agency unveiled a new, handheld technology—developed under the auspices of the President's Malaria Initiative, launched in 2005—that will be tested in Africa to detect counterfeit and ineffective anti-malarials.
FDA Commissioner Dr. Margaret Hamburg said during a news conference that the “FDA hopes the testing will demonstrate the effectiveness of this tool and encourage its wide-scale use to significantly improve the integrity of products that end up on the dinner table or at the bedside of patients in the United States and around the world.”
Despite the FDA's efforts, the Government Accountability Office has expressed concerns that the agency is simply underpowered to keep a close eye on every step of the supply chain. Those foreign inspections reflect only a small fraction of the facilities that are subject to scrutiny. “FDA faces limits on its ability to require foreign establishments to allow it to inspect their facilities,” the GAO noted in a 2011 report, Drug Safety: FDA Faces Challenges Overseeing the Foreign Drug Manufacturing Supply Chain. “Logistical issues preclude the FDA from conducting unannounced inspections, as it does for domestic establishments,” according to the report.
The AEI's Bate says FDA inspections are important, but that they are not the solution. “It's going to come down to companies themselves,” he says. The drug industry also inspects the plants they use to make the active ingredients in pharmaceuticals, but Bate says it's impossible to be perfectly thorough.
Imagine the challenge: multiple suppliers of raw ingredients feed into production of the active and inactive ingredients. To fully keep an eye on the entire supply chain would have to include these suppliers, the facilities where the drug is formulated, and the plant where it is packaged. Checking on them once does not mean they will be in the same condition the next time round, Lukulay says.
“You can't run every test on every chemical because you'd run out of money,” Bate says. He proposes an auditing system that pools resources from companies to form a stronger overall inspection presence abroad. None is planned, according to a spokesman for the Pharmaceutical Research and Manufacturers of America, the drug industry's major trade group.
Meanwhile, the generic drug industry contends that substandard medicines are not a problem for the U.S. market. “There just isn't a substandard issue here” in the U.S., says David Gaugh, senior vice president for sciences and regulatory affairs at the Generic Pharmaceutical Association.
Gaugh points to the rigorous testing criteria required to import drugs for sale in the U.S. But as Lukulay notes in the case of heparin, “just because there are good manufacturing practice audits conducted, there is no fool-proof way to say you can't end up with a bad API supplier.”
Templeton at Geisinger says her group relies on the quality-control measures by manufacturers and “assumes that we're getting good quality products.” But she says it's also incumbent upon doctors and other users to take action when something doesn't appear right.
As much as globalization might introduce risk, Bate says it can't be stopped, nor should it be. “If we stop buying from these countries we'd have many more (drug) shortages than we do and prices would go up a lot,” he says.
Attaran is hopeful that the problem might work itself out over time by companies' refusing to put up with poor-quality products. Ranbaxy quickly evaluated its problems and put in corrective measures to prevent a recurrence. While the company has since renewed selling atorvastatin, “this was a blemish in our overall corporate complexion,” says Chuck Caprariello, a spokesman for the company. Ranbaxy never recovered its previous share of the market.
Baxter never resumed selling heparin and sold the division that made the drug. “Companies will make the calculation,” Attaran says. “Is it worth the damage to one's brand, is it worth the PR nightmare, the settlements to injured persons, to save a little money by sourcing from unreliable locations?”
Kerry Grens is a freelance writer in suburban Chicago. Reach her at [email protected]