A: We’re very familiar with the FDA. Dr. Mike has served on FDA advisory committees for 16 years, chaired an FDA advisory committee and even has shepherded specific drugs through trials. The agency is understaffed, underfunded and overworked. That’s why even though generic drugs make up about 80 percent of all prescriptions in North America, according to the FDA itself, the agency doesn’t have the resources to perform independent clinical studies of generics and lacks the authority to require the industry to conduct such studies. But that’s all about to change.
Recently, the FDA was forced to halt the sale of generic drugs from two Indian facilities (Ranbaxy Labs and Wockhardt Ltd.), citing issues of drug safety. That put a scare into the FDA, consumers, doctors — and the more worthy manufacturers of generics.
They know if generics get a reputation as unreliable or dangerous, no one will want to take any generic, even ones that are completely equivalent, safe and effective. So the manufacturers have bumped up the FDA’s paltry $2 million budget for dealing with generics to $20 million and are sponsoring a testing program. According to Bloomberg News, this will be the first time the FDA has begun a widespread effort to check and evaluate the quality of generics. Starting with generic heart drugs, ADHD treatments, immune suppressants, anti-seizure medicines and antidepressants, Duke University, Johns Hopkins, Brigham & Women’s Hospital and the universities of Florida, Michigan and Maryland will conduct the research into the quality and efficacy of the medications.