Generic-Drug Failure Prompts FDA to take Action

Generic drugs, non-name brand medications that cost far less than the brand-name, came under greater scrutiny recently after the U.S. Food and Drug Administration (FDA) banned imports of treatments made from two Indian facilities (Ranbaxy Labs and Wockhardy Ltd). The agency was forced to halt sale of generic drugs from these facilities due to drug safety. This spurred fear in the FDA and consumers alike, who are less likely to take generic drugs if they develop a reputation for being dangerous-even if they safe and just as effective. Generic medications make up nearly 80 percent of US prescriptions.

Now, $20 million is being poured in to investigate the safety of generic drug. FDA officials confirmed that at least a dozen academic centers will be involved in a testing program that will run through 2017. This year, the research will focus on heart drugs, ADHD treatments, immunosuppressants, anti-seizure medications and antidepressants.

The agency also said they plan to be more transparent about the way they regulate the $30 billion industry, Bloomberg reports. These efforts being made to assure consumers that proper safety measures are being employed.

“Our vision with setting up a communications team in OGD is to help educate the public about the drugs that fill the majority of prescriptions in the U.S. and help consumers and health-care providers understand that generics approved by the FDA are of high quality, safe, and effective,” said agency spokeswoman Sandy Walsh to Bloomberg.

Kathleen Uhl, acting director of the FDA’s Office of Generic Drugs, said in an interview at the Generic Pharmaceutical Association annual meeting in Orland that the FDA has wanted to test generics for a long time, but “we didn’t have money for that,” Prior to this year, “there was a very small research program — $2 or $3 million each year.”