FDA failed to track substandard generic medicines, Congress told
The Food and Drug Administration has failed to track the effectiveness of generics that make up 80 percent of medicines sold in the United States, according to doctors and researchers who told Congress yesterday that new efforts by the FDA still aren’t strong enough.
Generic heart drugs made by some India-based companies don’t work as they should, said Preston Mason, a researcher at Brigham & Women’s Hospital in Boston who has studied the effectiveness of copies of Pfizer’s Lipitor made both in the United States and abroad. That may be because some companies are cutting corners to save money, he said.
“This is the Wild West, the whole generics business,” Mason told about 50 congressional staff and representatives from the White House, the State Department and FDA who attended the congressional briefing yesterday.
Many of the generic drugs studied “at best didn’t work, and at worst may have had adverse affects on the body,” Mason told the group.
The FDA has begun a $20 million generic-drug testing effort working with academic centers. At the same time, Commissioner Margaret Hamburg said during a visit to India this month that the FDA will increase the number of plant inspections it does there. Several said these steps, along with a training program for government regulators in India, aren’t enough to ensure that copycat medicines used in the U.S. are safe.
Speakers urging formal congressional hearings included Amir Attaran, a law professor at the University of Ottawa, and Dinesh Thakur, a former executive at Gurgaon, India-based Ranbaxy Laboratories. Thakur was a whistle-blower in allegations Ranbaxy didn’t provide proper data on drug testing, charges settled by a guilty plea in May.
In 2012, Congress gave the FDA the authority to collect fees from the generics industry, in part, to increase inspections overseas.
Still, Attaran said, “we need more eyes on this in Congress. The rules in this country leave the doors too wide open to medicines in question.” He suggested the FDA focus on the capacity of foreign regulators to meet U.S. standards rather than inspecting as many facilities as possible.
Roger Bate, a researcher on international health policy at the Washington-based American Enterprise Institute, questioned whether more inspections are the best path, or whether doctors and patients should be given more information on where drugs and the ingredients come from so they can offer their own regulation by refusing to use certain products.