FDA gets new inspection powers with PDUFA

The FDA user fee reauthorization law has been sent to President Obama for his signature. So, what does that mean to drug manufacturers? It gives the FDA more leeway to inspect drug and API plants in foreign countries, with a special emphasis on China. In testimony to Congress this year, Janet Woodcock, the FDA's director of the Center for Drug Evaluation and Research, pointed out that there are now more foreign drugmakers than U.S. drugmakers for it to inspect. The law also will allow drugmakers to hire non-government inspectors to assess whether factories are meeting U.S. quality standards and offer their data to the FDA as support of the companies' manufacturing processes, Manufacturing Net reports. As far as counterfeiting, it reports that the law will increase the maximum penalty to $4 million and 20 years in prison from the current $10,000 and three years in prison. Not making it into the law, however, were provisions for a track-and-trace program that would have allowed companies and the FDA to monitor drugs from manufacture to delivery. The industry wanted to phase in requirements, and so the cost of the program. Story | More