In a recent post, we told you about some of the striking findings in a recent Center for Justice & Democracy report, America’s Unaccountable Generic Drug Industry: How Legal Immunity Could Be Making You Sick. For example, 80% of the drugs Americans take are generic but if we’re hurt by any one of them, there is virtually no way to hold the generic company accountable in court. Moreover, these drugs are much more likely than their brand-name counterparts to be manufactured overseas in factories in India and China, where potentially dirty and dilapidated factories often go uninspected by the FDA.
One huge Indian company, Ranbaxy, has a particularly atrocious record of misconduct. So imagine our surprise when we saw Ranbaxy back in the news. Seems like the FDA found a host of new violations upon inspecting Ranbaxy’s plant in Toansa, Punjab.
As the New York Times points out, Ranbaxy is already prohibited from exporting finished drug products to the United States from any of their main Indian manufacturing plants, because of fraud, forgery, and issues with subpar drugs they’ve sold in the past. However, despite recently pleading guilty to violating the federal drug safety law and making false statements to the FDA, Ranbaxy is still allowed to make and export ingredients to the United States that are then used in drugs manufactured in a Ranbaxy plant here in the United States.
In other words, a company that recently engaged in fraud and unsafe practices is still sending generic drug ingredients from foreign factories to the United States.
The only good news, if the discovery of FDA violations can be considered good news, is that the agency actually inspected the factory at all. As CJ&D noted, the FDA rarely inspects foreign drug manufacturing plants. In 2009, it inspected 11% of them. Not only that but these inspections usually occur only at certain parts of the supply chain. Inspections are typically limited to finished products (which Ranbaxy no longer exports to the US) or active pharmaceutical ingredients. Factories that produce inactive ingredients (which can affect a drug’s absorption into the bloodstream) may never be inspected at all!
In fact, as CJ&D’s report additionally points out, Ranbaxy’s past issues (fabricated data, substation of brand-name drugs for their own generics in bioequivalence studies, skipping steps, backdating data, and forgery), weren’t even discovered by the FDA. Instead, a whistle-blower had to come forward with proof of Ranbaxy’s misconduct; otherwise the FDA may never have learned of them at all. But even now with increased FDA oversight, Ranbaxy doesn’t seem to be changing its practices.
As Avrind Bothra, a pharmaceutical analyst explained to the New York Times about the Punjab factory, which “supplies roughly 70 percent of Ranbaxy’s active pharmaceutical ingredients” to the US market, “’If this plant also comes into F.D.A. issues, it means that the company has not spruced up its quality controls even four years after continued F.D.A. supervision… That raises concerns whether, over all, the company would be able to come out of this F.D.A. scrutiny.’”
Unfortunately, as CJ&D’s report points out, the problem of dangerous overseas generic drugs goes deeper than Ranbaxy. And holding these companies accountable is very difficult. Holding foreign manufacturers accountable in the United States for its dangerous products has always been hard.
One step that could help is passage of the Foreign Manufacturers Legal Accountability Act.This Act would “make it easier for an injured consumer to serve the foreign manufacturer with notice of pending claims, so the consumer can proceed with a lawsuit.”
In the meantime, as the demand for generic drugs rises so is the production of these drugs in foreign manufacturing plants. Lets hope the FDA means it when it says it is increasing overseas inspections so that American consumers don’t have to pay the price by falling ill from an unsafe generic drug.