The New York Time’s lead story on Valentine’s Day was about India’s drug industry, which probably freaked out a lot of people including lawmakers and regulators. To sum up the article, India exports (including to the U.S.) about $15 billion worth of drugs each year and one in five are counterfeit. And don’t even get us started on China:
American businesses and F.D.A. officials are just as concerned about the quality of drugs coming out of China, but the F.D.A.'s efforts to increase inspections there have so far been frustrated by the Chinese government.
“China is the source of some of the largest counterfeit manufacturing operations that we find globally,” said John P. Clark, Pfizer’s chief security officer, who added that Chinese authorities were cooperative.…
The United States has become so dependent on Chinese imports, however, that the F.D.A. may not be able to do much about the Chinese refusal. The crucial ingredients for nearly all antibiotics, steroids and many other lifesaving drugs are now made exclusively in China.
There is almost no quality control or oversight in these countries, and that’s what keeps the drugs so cheap. And that brings up the issue of generics, which as most people know, are much cheaper than brand-named drugs. Everyone wants to keep it that way. Gee, if only they weren’t fake!
Yesterday in Washington DC, during a briefing for “about 50 congressional staffers and representatives from the White House, the State Department and the FDA,” Preston Mason, a researcher at Brigham & Women’s Hospital in Boston, called the whole generics business “the Wild West.” He said the FDA was failing “to monitor the effectiveness of generics that make up 80 percent of medicines sold in the U.S.” and that “generic heart drugs made by some India-based companies don’t work as they should” which “may be because some companies are cutting corners to save money.”
Mason’s research included 36 different copies of the Lipitor cholesterol pill collected from 15 countries. … Many of the drugs Mason studied “at best didn’t work, and at worst may have had adverse affects on the body,” he said at yesterday’s briefing. The meeting at the Capitol was organized at the request of the speakers to educate lawmakers in hopes of moving toward formal congressional hearings on the topic.
But as might be expected, and unfortunately for everyone concerned about the safety of generic drugs, the next congressional hearing on the topic of generics isn’t to examine this huge problem. Instead, the U.S House of Representatives' Energy and Commerce Committee is holding a hearing on Monday to examine industry “concerns” over a new proposed FDA safety rule. This is a rule that addresses significant regulatory gaps in the agency's current generic drug labeling regulations.
These regulations currently allow a generic drug manufacturer to maintain a label even if it knows that label to be inaccurate and out-of-date. As we have noted before, in addition to raising serious safety concerns, the current regulations have had severe legal consequences for patients harmed as a result of unsafe generic drug labels. So the FDA is proposing to change this rule and kudos to them. Many organizations and the New York Times itself have already implored the agency to implement this common sense rule change. We hope they are listening to the right people. (If you would like to weigh in, March 21 is the deadline.)