After months of ever expanding drug recalls, and multiple investigative reports by different media outlets calling into question the safety of the U.S. generic drug supply (see, for example, “America’s Love Affair with Cheap Drugs has a Hidden Cost,” “How a Tainted Heart Drug Made in China Slipped Past the FDA,” and “Culture of ‘Bending Rules’ in India Challenges U.S. Drug Agency” all published earlier this year by Bloomberg, as well as “When Medicine Makes Patients Sicker” published earlier this year by Kaiser Health News) Commissioner Gottlieb and Center Director Woodcock took the unusual step of issuing a press release to refute some of the allegations in these reports.
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. 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.
Apart from the standard statements that we’ve previously heard from FDA, such as the fact that generic drugs are just as safe and effective as their brand drug counterparts, and that FDA continuously analyzes data to ensure the quality and safety of both generic and brand drugs throughout the products’ lifecycle, the press release included some new information.
For example, the agency stated that pharmacovigilance data regarding Atorvastatin (the generic name for Lipitor), which has been in the news lately, indicates that there is no evidence that any single generic version of this drug was more likely to be associated with adverse events than any other, and also that there is no evidence that any Atorvastatin generic drug was more likely to be associated with adverse events than the innovator product. It is instructive that the agency did not make similarly specific assertions regarding any of the other drugs referenced in the recent media reports cited at the top of this posting.
Also, to rebut suggestions in the media that the perceived problems with generics were due to the diminished number of surveillance inspections, the press release seemed to acknowledge the reduced number of inspections while at the same time dismissing its significance due to the agency’s improved targeting of inspections where they are most needed:
“While the numbers of inspections have varied over the past few years, compliance actions, including warning letters, have increased. Warning Letters to human drug manufacturers regulated by the FDA’s Center for Drug Evaluation and Research (CDER) have steadily increased over the past four years. In fact, in FY 2018, CDER issued nearly five times as many warning letters to human drug manufacturers as it did in FY 2015.
19 in FY 2015;
43 in FY 2016;
67 in FY 2017; and
94 in FY 2018.
But it’s important to note that we don’t believe this reflects a growing problem in drug quality. On the contrary, the FDA’s improvements to targeting inspections and in evaluating recommendations for enforcement action mean more attention is being given to higher risk facilities than ever before. By better focusing our inspectional resources on higher risk facilities, we can identify potential quality problems that have the most impact on consumers. Then, we can take appropriate action to address our public health concerns.”
Another FDA statement that we are all familiar with, and that was repeated in the press release, is that drugs manufactured outside the U.S. are required to meet the same standards as drugs made domestically. In addition, the agency added that: “…the FDA labs tested 323 products from around the world – including more than 100 from India – to determine if foreign manufacturers had a higher incidence of product failure. All 323 samples met U.S. market quality standards using testing standards set by the United States Pharmacopeia (USP) or submitted in marketing applications.”
However, what the press release fails to mention is whether the samples from India had, on average, exceeded pharmacopeial standards by as much, or more, as the products manufactured in the U.S. and other first world countries. What also remains unanswered is whether the FDA disagrees with the implication from these recent media reports that, on average, there are more frequent and more significant quality problems with drugs emanating from developing countries than with drugs emanating from the developed world and, if so, what more will FDA be doing to deal with these issues?