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FDA Changes Tune On Approving China-Developed Drugs

Last updated on February 10, 2022

Regulators in the United States are wary of some drugs that have been developed in China and could reportedly put off approving dozens of medicines.

This move could mostly affect the strategies of drugmakers in the West, such as Eli Lilly and Novartis, which were potentially going to make billions of dollars in sales by transferring these drugs from China to America, The Wall Street Journal reported.

For example, Lilly was reportedly hoping to push out a China-developed lung-cancer immunotherapy and offer it at a lower cost than similar medicines that are already for sale.

But the U.S. Food and Drug Administration (FDA) might hold back on approval, jeopardizing the plan. On Thursday, FDA advisers are going to look at proof for the drug from Lilly and its Chinese partner Innovent Biologics.

The advisory committee is anticipated to vote on whether or not to recommend that the FDA approve the medicine and talk about if its Chinese clinical trial outcomes can apply to people in the U.S.

As Biopharma Dive reported, “[o]n Tuesday, the FDA posted briefing documents for the Thursday meeting that showed its staff to be highly skeptical of Lilly’s and Innovent’s drug.”

The drug application being considered is the use of the drug with chemotherapy in certain patients, but “the study was run entirely in China and chemotherapy is no longer the bar to clear in lung cancer, two factors that appear to be influencing the FDA’s thinking. The agency is expected to make a decision by March,” the outlet noted.

Authorities at the FDA reportedly note that they are worried about the standard of studies looking at medicines developed in China. They are also worried that U.S. patients haven’t been part of the studies for these medicines.

“We have nothing against drugs being developed in China,” said Richard Pazdur, director of the FDA’s cancer-drugs division. “Our issue is, are those results generalizable to the U.S. population?”

Executives in the pharmaceutical industry and analysts have also reportedly noted that this change in approach could end up causing postponements or entire rejections by the FDA of attempts to transfer an increasing amount of drugs to patients in America.

Some experts have said that Chinese biotech organizations and their partners in the West might need to carry out more testing of their potential new medicines in U.S. patients.

A few years ago, the tune was different. In 2019, the FDA approved “Brukinsa, a lymphoma treatment from BeiGene Ltd., that had been primarily tested in China. Most subjects in the clinical studies that led to the approval were in China, but some were in the U.S.,” the Journal noted.

That year, Pazdur 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 Pazdur’s wording as providing a type of go-around for China-tested medicines to be accepted in the United States without going through longer trials in America.

“Now that path appears to be closing,” Bernstein analyst Ronny Gal said in an interview with the Journal. He said Pazdur’s recent discussion came to “a clear change in tone at the FDA, from encouraging this to discouraging this.”

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 Journal noted, adding, “There may be differences between countries in medical care and population that affect how a drug performs, he said.”

Pazdur also noted that the FDA is more easily able to welcome China-only clinical information for diseases that are not as widespread in the U.S. as they are in Asia. He also stated that he was worried the Chinese studies utilized study designs that are no longer current and don’t specifically show if the medicine developed in China is as effective as similar medicines recently approved in the U.S.

“He also expressed concern about the integrity of data generated by drug studies in China,” the outlet added.

The Journal noted how 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 “fraudulent or substandard by the country’s drug regulator.”

“The elephant in the room is obviously, what is the quality of the data that is coming from these foreign countries?” Pazdur said.

China has also been on the U.S. radar in the past several months due to its human rights abuses alongside its hosting of the 2022 Winter Olympic Games.

However, another major factor affecting the United States and China is China’s apparent inability to carry out its end of a trade deal with the U.S.

On Monday, U.S. authorities called for “concrete action” from the country to follow through on “its commitment to purchase $200 billion in additional U.S. goods and services in 2020 and 2021 under the ‘Phase 1’ trade deal signed by former President Donald Trump,” per Reuters.

Through the month of November, China had reportedly only achieved around 60% of the goal, per trade data put together by Peterson Institute for International Economics senior fellow Chad Bown, according to Reuters.

Brown also reported, “In the end, China bought only 57 percent of the US exports it had committed to purchase under the agreement,” which Brown claimed is “not even enough to reach its import levels from before the trade war. Put differently, China bought none of the additional $200 billion of exports Trump’s deal had promised.”

One of the U.S. officials reportedly said, per Reuters, “Because we inherited this deal, we engaged the (People’s Republic of China) on its purchase commitment shortfalls, both to fight for U.S. farmers, ranchers and manufacturers and give China the opportunity to follow through on its commitments. But our patience is wearing thin.”

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