Whistleblowers, inspections, and the drug safety drumbeat
Protecting the public’s health shouldn’t fall to the whistleblowers, an editorial in yesterday’s Boston Globe says, pointing to a $750 million GlaxoSmithKline settlement late last month in which a whistleblower claimed the company had knowingly sold unsafe drugs into the market. As we wrote earlier, it’s a significant settlement for being the first to successfully allege a company knowingly sold unsafe drugs. The Globe concludes that the GSK suit—in which FDA inspectors at the Puerto Rico plant found the contamination problems—shows that this time the system worked: “But beefing up the FDA’s drug-manufacturing inspections should keep drug makers from foisting contaminated medications on the public in the first place — and keep the government from having to share fraud-recovery millions with whistle-blowers.”
Meanwhile, the House Oversight and Government Reform committee has its eye on Puerto Rico too, but on the FDA office there, which was thrown into the spotlight during the Johnson and Johnson “phantom recall” hearing earlier this fall.
“It appears that FDA’s Puerto Rico district office may be having difficulty exercising oversight on the numerous pharmaceutical manufacturing facilities on the island,” committee Chairman Edolphus Towns and Ranking Member Darrell Issa wrote. “We question whether the Puerto Rico district office is adequately staffed to fulfill the agency’s mission of securing the nation’s pharmaceutical supply.”
While the latest GAO report suggests that FDA still isn’t inspecting anywhere close to the number of overseas plants involved in the manufacture of U.S. drugs, it does suggest the FDA has stepped up vigilance and focused resources on the problem—and in a major way (quadrupled funding for foreign inspections indicates more than an incremental shift from the status quo.)
That’s a sharp contrast to the tenor of an interview with J&J CEO William Weldon this week, in which he focused more on the image recovery campaigns his company has planned than fixes to the manufacturing problems that lead to the recall of millions of bottles of product in the last two years. The interview took place less than a month after more Tylenol was recalled for complaints of musty odors.
Whistleblowers, investigations, and stepped up regulation all mean information, and to our mind, the more information, the better. It’s encouraging to see that over, under, or through the ballot-box sound and fury, the drumbeat call for drug safety persists, and maybe it’s just our fondness for the bass line, but we hope it gets stronger.
–Kate Petersen, PostScript blogger