China, being the only supplier for many drugs in the United States, has Congress analyzing our country’s drug supply chain of generic pharmaceuticals.
In a recent congressional hearing, the lack of oversight in the Food and Drug Administration was magnified by lawmakers.
“There’s a hidden health crisis in this country that will affect us all,” Rep. Anna Eshoo of California, Chair of the Health Subcommittee, said in the hearing.
“The crippling inadequacy of the American drug supply.”
This hearing was requested after numerous concerns were expressed regarding recalls of Chinese-manufactured medications which were found to contain carcinogenic ingredients.
“In short, we’re overly reliant on China, we cannot trust the supply chains, and our national and economic security demand that we act,” said Michael Wessel, commissioner of the U.S.-China Economic Security Review Commission.
The Food and Drug Administration has been forced to make several recalls in the past few years, including a few heart pressure medications and a heartburn medication called Zantac.
All of these recalls were due to potentially carcinogenic components intruded by Chinese Manufactures who failed to include these components in their reports.
One of the most fundamental components to the generics industry are the APIs-active pharmaceutical ingredients, that make up a crucial part of the drugs that generics share brand-name counterparts with.
Congress is considering legislation that would allow the FDA to be held accountable for the oversight of these manufacturers product of APIs, how much, and how often it is produced.
Janet Woodcock, director of the Center for Drug Evaluation and Research at the FDA is insistent that this occurs so that the manufactures will legally be required to provide all proof of production for APIs.
While there is a financial appeal to international manufacturing in places such as India and China, Woodcock claims the FDA’s advocation to push modernization to the foreign manufacturers including automation will ease costs.
Several concerned lawmakers are hopeful that the low cost doesn’t keep too many manufacturers in international locations. Many specifically addressed Woodcock to address if companies could be convinced to return all manufacturing back to the United States.