The Food and Drug Administration approved Qilu Pharmaceuticals from Shandong, China, to sell the generic oncology drug cisplatin, along with fellow chemotherapy drug carboplatin, in an effort to avoid more shortages in the U.S.
The Food and Drug Administration approved Qilu Pharmaceuticals from Shandong, China, to sell the generic oncology drug cisplatin, along with fellow chemotherapy drug carboplatin, in an effort to avoid more shortages in the U.S. There is an ongoing shortage of critical cancer drugs in the U.S. Due to decades of offshoring pharmaceutical manufacturing, and predatory tactics and and subsidies by foreign governments, the U.S. does not produce enough of a supply of these drugs at home. Recently, that has led the FDA to look to unapproved Asian labs to fill growing gaps in domestic critical medicine supplies.
“We’ve taken steps for temporary importation of certain foreign-approved versions of cisplatin products from FDA-registered facilities and used regulatory discretion for continued supply of other cisplatin and carboplatin products to help meet patient needs,” FDA Commissioner Dr. Robert Califf said.
Qilu received permission from the FDA in May. The scarcity of cisplatin in the U.S. was noted by the FDA in November following problems at India’s Intas Pharmaceuticals, a lab that has received numerous red flag reports over the last year and is reportedly responsible for nearly half of critical oncology medication used by cancer patients.
There are currently more than 130 drug formulations in short supply domestically, according to the FDA.
Cancer drug shortages have been exacerbated by offshoring of generic drugs. Now, patients and cancer doctors are often left to search for substitutes. Sometimes the FDA allows for imports of drugs from labs that have even received import restrictions or warning letters by inspectors following lackluster visits to foreign labs. Patients and doctors are then left to choose between no medication, or one that has not been inspected, or comes from a lab that has run afoul of the FDA’s current good manufacturing practices required to sell drugs in the United States.
Anthony Sardella, Chair, API Innovation Center, Adjunct Lecturer & Senior Research Advisor, Center for Analytics & Business Insights, told the House Commerce Committee in May that 25% of generic drugs over the last 26 months were made in facilities that have received FDA warning letters.
A National Comprehensive Cancer Network survey, published in May, found that 93% of 27 cancer treatment centers surveyed are low on carboplatin, whereas 70% reported a cisplatin shortage.
Qilu is one of China’s leading, global pharmaceutical companies. It focuses on the development, manufacturing and marketing of generic drugs and active pharmaceutical ingredients(APIs) primarily for use in oncology, cerebrovascular and cardiovascular medicines; anti-infection medication, along with psychiatric drugs.
The company also works as a contract manufacturer for U.S. labs. In 2021, Sesen Labs in Cambridge, Mass., signed a deal with Qilu to make one of its cancer drugs, selling under the trademark name of Vicineum.
In 2022, Pfizer sued two former Chinese lab technicians for IP theft. They employees later created a company called Regor Therapeutics, which counts Qilu as one of its investors. The case is still in the discovery phase.
The U.S. is the world’s leading pharmaceuticals market and is one of the leading sources of the U.S. trade deficit with Europe and India.
We are a group of doctors, patients, health care industry experts, and advocates fighting to ensure all generic medicines are safe, affordable, and always available. Unsafe generic drugs from foreign manufacturers in China and India have been sold in the U.S that have been contaminated with carcinogens and fake ingredients, fall apart when tested, and don’t work as they should. We are fighting back to ensure all generic medicines are safe, affordable, and always available. We want every American to be able to trust the generics they take—every pill, every vial, every time.