FDA Allows Uninspected China Lab to Sell Cancer Drugs in the US

Always struggling to balance supply and safety, the Food and Drug Administration will allow for cancer drugs from an uninspected lab in China to be sold in Florida. Reports said that the FDA was concerned over supply constraints, something the FDA has said numerous times before regarding drug shortages.

The FDA is allowing the chemotherapy drug cisplatin, made by Qilu Pharmaceutical in China, to be distributed in the U.S. via Apotex Corp. – a Canadian distributor based out of Toronto.

“In these situations, we very carefully assess product quality and require companies to take certain measures to ensure the products are safe for patients,” FDA Commissioner Robert Califf said on this Twitter page on June 2. Just because a lab is registered to sell drugs to the United States, it does not mean that it has passed any recent inspections by the FDA. In this case, Qilu has not seen an FDA inspector in four years.

A Generics Drug “Crisis”

It will take two to four weeks before the Chinese lab can send cisplatin to the U.S., Dr. Lucio N. Gordan, president and managing physician of Florida Cancer Specialists & Research Institute, told the local Naples Daily News on June 7.

Gordan said there needs to be a “permanent solution” to generic drug shortages that have existed for nearly two decades. “We have never had a concerted effort to fix the generic drug crisis before but it has not been as severe,” he said. “This is severe.”

Also this month, the FDA allowed for India-based Intas Pharmaceuticals to continue selling cancer drugs to the United States even after a disastrous inspection late last year that made it onto the pages of The New York Times. That inspection of the Intas lab, which took place beginning in late November 2022, found shredded documents that had details of drug manufacturing practices that the FDA could not verify, so they ultimately slapped an Import Alert on the lab on June 1. Lab records and documentation are an important part of the inspection process. Without proper records, FDA inspectors have no idea if a lab is following Current Good Manufacturing Practices, which are required in order to sell pharmaceutical products in the U.S.

But, due to drug shortages here in the U.S., the FDA is allowing for medications made at that lab to be sold here to this day.

Dr. Karen Knudsen, CEO of the American Cancer Society, said drug shortages highlight a long-standing economic problem in the generics market. “We need it to be financially viable for manufacturing to be able to produce effective, affordable cancer therapies. The fact that we’re sitting here right now talking about this cancer shortage tells us that there are not enough manufacturers to be able to overcome the supply chain issue,” she said.

Cardiologist Harry Lever from Cleveland, OH said he would “never give a patient a drug from an unapproved facility.”

The last time the Intas Pharmaceuticals labs in India was inspected was on Feb. 28, 2020, according to the FDA’s inspections database. Qilu Pharmaceuticals was last inspected in 2018, according to the FDA’s database.

The FDA inspects domestic drug manufacturing labs once every two years, at a minimum. But foreign labs are inspected less.

Many of those labs from India, in particular, have voluntarily recalled drugs over the last year – including everyday medication to control high blood pressure. It is unclear how many labs do not voluntarily recall medication found to be tainted upon in-house inspection, and continue selling to the U.S.

The drug shortage story is becoming more mainstream. On June 7, the Today show did a story about a man who had to stop chemotherapy treatment due to supply.  The drug in question was cisplatin. To help patients often fighting for their lives, the FDA has opted to import drugs from uninspected labs.

“We can’t risk patients’ lives by giving them potentially bad drugs from unapproved manufacturers,” Lever said. “Congress must act quickly to increase production of lifesaving medicines in the U.S. Our country is in a national health care crisis and we can’t afford to be reliant on foreign manufacturers making bad drugs.”