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| Amir Attaran--Courtesy of University of Ottawa |
The FDA reported last week that for about 6 months it has been testing some generic drugs to see how they stack up to the branded products they mimic. That $20 million effort is laudable, but it isn't enough to ensure the generics that fill the medicine cabinets of U.S. consumers are both safe and effective, according to critics of foreign-made pharmaceuticals.
"The rules in this country leave the doors too wide open to medicines in question," Amir Attaran, a law professor at the University of Ottawa, said at a congressional briefing Wednesday, according to Bloomberg. About four dozen congressional staff, FDA, White House and State Department representatives listened to what Attaran and others had to say, Bloomberg reported.
A series of speakers, including researcher Preston Mason with Brigham & Women's Hospital in Boston, said manufacturing problems at many foreign pharma factories leave impurities that render some generics ineffective, if not dangerous. According to documents presented at the briefing, Mason tested dozens of generic versions of Pfizer's ($PFE) cholesterol-lowering drug Lipitor from about 30 manufacturers. His study, published last year, found problems with impurities in many of the foreign-made copies but none in those produced by U.S. firms Mylan ($MYL) and Watson, now Actavis ($ACT).
One of the speakers Wednesday was Dinesh Thakur, a former chemical engineer for Ranbaxy Laboratories. His whistleblower lawsuit led to sanctions against the Indian drugmaker, $500 million in penalties and guilty pleas from the drugmaker for selling adulterated drugs. According to his prepared statement, Thakur told the group that despite the FDA's best efforts, problems will persist until all foreign regulators are more concerned about consumer safety than promoting the commercial interests of their countries. Since its settlement last May, Ranbaxy has had two plants banned by the FDA from shipping products to the U.S. because of ongoing problems. Indian regulators have reported finding no serious problems with the drugmaker.
FDA Commissioner Margaret Hamburg recently returned from a trip to India where she met with regulators and government and industry officials. She said they pledged more collaboration with the agency and agreed to have Indian drug inspectors join FDA inspectors during plant visits to learn what the FDA expects from drugmakers. That would be a mistake, according to an op-ed piece in Forbes this week by Thakur, Attaran and Roger Bates. Giving Indian regulators the FDA "playbook... may inadvertently make it easier for Indian companies to cheat," they said. They suggested Congress levy "severe penalties in the form of trade barriers on any country that repeatedly exports poor quality medicine to America."
Bates is well known for his research into counterfeit and subpar drugs done for the American Enterprise Institute. He suggested at the briefing that Congress consider a market-driven approach to weeding out bad actors. Give doctors and patients more information about where the drugs and ingredients that go in them come from. Then if they worry about the safety and effectiveness, they can refuse to buy them.
- read the Bloomberg story
- see the prepared remarks (PDF)
- here's the op-ed in Forbes