- The Food and Drug Administration on Friday defended its oversight of generic drugs imported from abroad, taking the unusual step of publicly refuting recent press reports that questioned whether the agency is effectively detecting and managing risks involving the copycat medicines.
- "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," FDA Commissioner Scott Gottlieb and Center for Drug Evaluation and Research head Janet Woodcock said in a Feb. 22 joint statement. "We believe these interpretations are seriously flawed and do not account for the full picture of our global vigilance over generic drug manufacturing."
- While Gottlieb and Woodcock did not specify which press reports the FDA sought to push back against, the agency likely is referring to a series of articles published by Bloomberg at the end of January. Tweets from Gottlieb at the time referred specifically to the publication and referred to a forthcoming response from the FDA.
A sprawling recall of tainted heart drugs has put the FDA's oversight of the generic drug quality under the microscope.
Over the past year, the U.S. regulator along with the European Medicines Agency have steadily expanded investigation of contaminated active pharmaceutical ingredient contained within generic angiotension II receptor blockers like valsartan, irbesartan and losartan. The contaminants in question, known as nitrosamines, are considered probable human carcinogens.
While the investigations and recalls have spread to encompass more than a half dozen companies, one Chinese manufacturer in particular — Zhejiang Huahai Pharmaceutical — has been at the heart of the problem, responsible for producing API found to be contaminated.
Against that backdrop, Bloomberg in January published a series of articles examining the role played by the FDA in overseeing recalls of valsartan API and questioning whether the agency was able to adequately monitor generic drug manufacturers in India and China.
In the case of Zhejiang Huahai, one of Bloomberg's articles highlighted that an FDA inspection of the drugmaker lead to a recommendation in 2017 to issue a warning letter. Agency managers, however, "overruled" the inspector, according to Bloomberg, allowing the company to attempt to solve the issues on its own.
Gottlieb and Woodcock, in their statement Friday, cautioned against drawing broader conclusions from such examples, noting that 75% of the time experts at FDA headquarters agree with inspection classification recommendations from field investigators.
"While one publicly visible measure of FDA action, it’s important to understand that warning letters are not the FDA’s only course of action with a manufacturer following an inspection," the agency officials wrote.
Spurred by another issue raised by Bloomberg — that Mylan's generic version of Lipitor (atorvastatin) was associated with more side effects than those made by other manufacturers — the FDA conducted a review of adverse event reports from Jan. 1, 2012 through Dec. 31, 2018. Data did not show any evidence that any single generic atorvastatin was more likely to be linked with side effects than another, Gottlieb and Woodcock said.
More broadly, the agency leaders defended the FDA's track record of inspecting generic drug manufacturers, pointing to a risk-based approach to inspections that has channeled resources to priority areas.
Even so, Bloomberg's investigation still highlights the challenge faced by the FDA in attempting to regulate an industry with an increasingly global footprint.
The regulator has had issues staffing offices in India with inspectors, for instance, closing a Mumbai office in 2016 and turning instead to flying U.S.-based investigators out to India. The rise of China in the global supply chain for API and generic drugs has required further resources from the FDA, adding to the burden on the regulator.
Partly in response, the FDA has steadily ramped up its cooperation with EU member state health agencies under a mutual recognition agreement that allows the agencies to rely on each other's inspections, potentially reducing redundant inspections of the same plants.