- Food and Drug Administration chief Scott Gottlieb defended this week the agency's response to the contamination of a class of heart drugs that resulted in widespread recalls, pushing back on questions of whether the regulator missed signs of potential risks.
- In January, the FDA announced it had zeroed in on what it believes was a contributing cause of potentially carcinogenic impurities detected in the raw ingredients used to make valsartan and other similar blood pressure medicines. Earlier changes in the manufacturing process for the drugs, among other factors, appeared to lead to the contamination.
- "I don't think this was a case where we didn't know that the process change was made," Gottlieb said at an event this week at the Brookings Institution in Washington. "I think this was a case where we didn't know this particular impurity could be introduced from the change that had been made."
Contamination of valsartan, and angiotensin II receptor blockers like it, stemmed from a Chinese manufacturer called Zhejiang Huahai Pharmaceutical.
Active pharmaceutical ingredient made by Zhejiang Huahai was found to be contaminated in mid 2018, spurring the FDA and European Medicines Agency to investigate and leading to rolling recalls from generic drugmakers which used the contaminated API.
It turns out, however, that the FDA actually inspected Zhejiang Huahai in 2017, but opted against taking a direct response to data integrity concerns flagged by inspectors.
Those concerns were unrelated to the impurities later detected in valsartan and other API, Gottlieb said Tuesday, noting the impurities are particularly hard to detect.
"After it was detected, I think the world regulatory authorities worked very quickly to test other products within the class," Gottlieb added. "I think the direct response was admirable and efficient."
Yet the FDA chief indicated that the agency could be better positioned to oversee how API manufacturers document process changes, noting forthcoming regulations might help.
"We are going to be promulgating the first real modernization of our GMP regulations in a very long time, looking specifically at the requirements we put on API manufacturers," Gottlieb said at the Brookings event. "Because that is where the vulnerability is, not just with respect to potential risks but also with shortages."
In particular, the FDA aims to impose more requirements on manufacturers to report process changes so regulators can conduct proper evaluations.
That task would fall to the agency's Office of Pharmaceutical Quality, which is staffed with organic chemists capable of reviewing how manufacturing changes alter the final product.
The FDA has put out several GMP-related manufacturing guidances in recent months. An FDA spokesperson said the agency "intends to continue modernizing or clarifying the regulations as needed to harmonize them with other FDA regulations and international cGMP standards."