|Center for Drug Evaluation and Research Director Janet Woodcock|
A group of researchers and doctors has been trying to get the attention of Congress for its contention that generic drugs made outside the U.S. are more likely to be tainted and ineffective. But FDA CDER Director Janet Woodcock says the research was flawed and their conclusions faulty.
Woodcock told Bloomberg that methods used in research concluding that foreign-made copies of Pfizer's ($PFE) Lipitor were tainted with impurities "didn't use the proper method to extract the active ingredient" from samples. The end result, she said, was that the methods contaminated the samples. She said a study about to be released by the FDA that looked at copies of heart drugs made in Canada, Slovenia and India using a different approach didn't find contaminants.
The work that had raised the question of effectiveness was done by Preston Mason, a researcher at the Harvard-affiliated Brigham and Women's Hospital in Boston. Mason defended his work against Woodcock's criticism, saying he used a consistent approach on all of the samples and only the foreign-made products showed flaws. If accurate, his research would suggest problems with the FDA's approval of the drugs.
He and others pointed to his research during a congressional briefing last month to suggest that foreign-made generics are not working on patients as they should. Dr. Harry Lever, a cardiologist at the Cleveland Clinic in Ohio, also testified at the briefing before congressional aides and administration officials, saying that his patients did better when switched from foreign-made generics to those produced by U.S.-based drugmakers. But Woodcock waved away his finding as well by saying that there is plenty of research that suggests patients will respond simply to the idea that another drug will work better.
Publicity around the group's contentions as well as FDA actions against Indian drugmakers for failing cGMP standards at some of their plants has ignited a debate in the U.S., particularly around Indian-made generics. India produces 40% of the generic and over-the-counter drugs used in the U.S., second only to Canada. In the last 10 months, the FDA has banned two plants owned by Wockhardt, an Indian plant of Sun Pharmaceutical and two more plants of Ranbaxy Laboratories, India's largest producer of generic drugs. Ranbaxy already had two of its plants under close FDA scrutiny for serious violations dating back more than 5 years.
But it was also Ranbaxy which was allowed to be first to market with a generic of Lipitor. Bloomberg, citing IMS Health statistics, said the company sold more than $1.3 billion worth of its drug in 2012. That was before having to recall 41 lots over the chance the API used to make them may have gotten ground glass in it.
- read the Bloomberg story