U.S. generic drugs are safe and effective, FDA commissioner reiterates

In a rare show of defensiveness, FDA Commissioner Scott Gottlieb, M.D., again turned to Twitter to defend the quality of the U.S. generic drug supply and the agency’s record of keeping consumers safe. 

In a series of tweets Friday evening, Gottlieb pointed out that not only have plant inspections increased in recent years, but that the Center for Drug Evaluation and Research's (CDER) new practice of using data to zero in on the biggest-risk facilities is making the processes better and more efficient.

The stream of tweets came in response to a year-long investigation by Bloomberg that has questioned the agency’s effectiveness in keeping drugs safe as it looks to approve more generics to keep drug prices lower for consumers.

“Recently, there have been reports in the press calling into question the quality of our nation’s drug supply and specifically, asserting that certain generic drugs are of a lesser quality than brand drugs,” Gottlieb and CDER Director Janet Woodcock declared in a joint statement. “Some of these reports claim to be based on data analysis. We believe these interpretations are seriously flawed and do not account for the full picture of our global vigilance over generic drug manufacturing.”

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Gottlieb in his tweets pointed out that in the last four fiscal years, FDA inspections of generic drug manufacturing facilities have increased, while the number of warning letters issued is up nearly five-fold. There were 24 warning letters issued in China last year and 15 in India, two of the countries that produce a large proportion of the generic drugs in the U.S. That compared to 19 warning letters issued in the U.S.

The joint statement said that FDA labs tested 323 products manufactured around the worldincluding more than 100 from Indiato see if foreign manufacturers had a higher incidence of product failure. They said all of the samples met cGMP standards.

It is the second time recently that Gottlieb has responded to the Bloomberg report which pointed to a number of questions including the discovery of probable cancer-causing impurities in blood pressure drugs made in China and India. He earlier took to the Twittersphere to say in addition to more FDA inspections of generic drug plants, preapproval inspections are up as the FDA approves more generic drugs.  He said since existing drugs are typically made in same plants as new generics, inspectors get a more frequent look at the facilities.

“We recognize that the U.S. market for pharmaceuticals has changed dramatically in recent years. In 1990, generic medicines only accounted for 33 percent of retail prescriptions,” the statement reads. “Today, generics account for 90 percent. Supply chains have also expanded globally. This has created new complexities, and new opportunities for novel risks. Our program has evolved to meet these new challenges, and we continue to implement policy measures to address emerging threats.”