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FDA Signals A Shift In Strategy For China-Developed Drugs

As western drug companies seek to introduce drugs into the U.S. that were developed in China, the Food and Drug Administration (FDA) is signaling it may not approve. 

Food and Drug regulators in the U.S. are wary of some drugs that have been developed in China, specifically regarding the standard of studies looking at medicines there. They’re also worried that U.S. patients haven’t been part of the studies for those medicines.

This could affect the strategies of some drugmakers in the West, like Eli Lilly and Novartis, which were potentially going to make billions of dollars in sales by transferring drugs from China to America. For example, Lilly was hoping to push out a China-developed lung-cancer immunotherapy and offer it at a lower cost than similar medicines already for sale. 

In a document posted online last week, FDA staff said the data from the clinical trial, which was done solely in China, “are not applicable to the U.S. population and U.S. medical practice.”

On Thursday, FDA advisers voted against supporting the FDA’s approval of the drug from Lilly and its Chinese partner Innovent Biologics.

A report published in the British Medical Journal in 2016 found that more than 80% of clinical trial data put forward for new drug registrations in China were “revealed as fraudulent or substandard by the country’s drug regulator.”

In 2019, the FDA approved a lymphoma treatment that had mainly been tested in China, with some participants in the U.S. That same year, Richard Pazdur, director of the FDA’s cancer-drugs division, spoke at a medical conference and said the FDA would accept Chinese-only drug-study outcomes if the data were “quality.” 

Some experts in the industry considered this wording as providing a go-around for China-tested medicines to be accepted in the U.S. without going through longer trials in America.

As The Daily Wire previously reported, for his part, Pazdur has said his discussion from 2019 has been misconstrued as pushing companies to take specific action.

“When drugs are tested only or primarily in one country such as China, Dr. Pazdur said, it is difficult to assess whether the drug would have the same benefits and safety profile in the U.S. population,” The Wall Street Journal previously noted, adding, “There may be differences between countries in medical care and population that affect how a drug performs, he said.”

Now, the FDA and the advisory panel appear to be more concerned with the lack of diversity of the participants in these types of studies. 

On Thursday, Pazdur spoke about the shift, saying, “Over the past two or three years, this country has experienced tremendous social change.” He said they “clearly heard from all patient groups that they want faces like theirs.” He said, “Single countries submissions is a step backward in achieving the racial diversity that we need in the United States.”

“At a time when the FDA and the industry are trying to increase diversity in clinical trials to ensure they are representative of the patient population to be treated, it makes no sense to move in the opposite direction with this application,” David Mitchell, a committee and founder of Patients for Affordable Drugs, said, per CNBC.

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