June 5, 2023 03:08 PM EDT PharmaFDA+ManufacturingFDA to import...

June 5, 2023 03:08 PM EDT PharmaFDA+Manufacturing

FDA to import versions of common cancer drug to alleviate shortage

The FDA is hoping its latest solution will stave off the continued shortage of cisplatin, a key drug used in treating several types of cancer.

Beginning tomorrow, orders can be placed for cisplatin shipments from China-based Qilu Pharmaceutical Co., which worked in coordination with the FDA and generic drugmaker Apotex to try to help with the shortage.

FDA Commissioner Robert Califf said on Friday that the agency began the process to import certain “foreign-approved versions” of cisplatin from FDA-registered facilities. According to a document, Qilu has started the “temporary importation” of cisplatin into the US even though the injection from Qilu is marketed and manufactured in China and is not approved by the FDA.

But Califf was adamant in his post that in situations requiring importation, the agency will “carefully assess product quality” and require the manufacturers to ensure the products are safe.

In these situations, we very carefully assess product quality and require companies to take certain measures to ensure the products are safe for patients.

However, no details as to the physical amounts or what steps Qilu is taking to comply with the FDA were immediately available. Endpoints News did reach out to Qilu but did not receive a response by press time.

The cisplatin shortage has been weighing on the FDA. Last week, Richard Pazdur, director of the FDA’s Oncology Center of Excellence, told The Cancer Letter that to restore the cisplatin supply the FDA is offering assistance to manufacturers to boost production and look at the temporary importation.

The importation of the drug is being met as a positive step by experts, but further steps do need to be taken to resolve the situation.

Erin Fox, an adjunct professor in the College of Pharmacy at the University of Utah, and an expert on drug shortages, emailed Endpoints that this move from the FDA is “good news” and will hopefully help. However, she noted that it is unknown if the amount being imported will make up the difference that Accord Healthcare, the US branch of Indian manufacturer Intas Pharmaceuticals, is not supplying.

Manufacturers such as Teva Pharmaceuticals, Hikma Pharmaceuticals, and Fresenius Kabi are all reporting a spike in demand, according to the FDA’s shortage list.

But Intas’ products, which include cisplatin and carboplatin, along with other cancer drugs such as methotrexate and fluorouracil, have recently been put under an import alert from the FDA until the company’s site in Taluka, India comes back into compliance with the FDA.

“Another unknown is if payers will cover this product since most cisplatin is given in the outpatient infusion setting. Overall though, this is better than not having more cisplatin! I’m hopeful if people start seeing the supplies come in it will remove some of the pressure on carboplatin,” Fox said.

The American Society of Health-System Pharmacists is also in support of the FDA’s efforts of importation as well.

“While importation may help ease supply, it is unlikely to entirely solve the problem, underscoring the need for policymakers to take immediate action to address the critical risk posed by drug shortages. Practitioners using the imported products need to pay extra attention to the labels and barcodes for the imported products, which may differ from the FDA-approved versions,” a spokesperson emailed to Endpoints.

Bipartisan lawmakers pressure FDA on common chemotherapies now in shortage

The FDA has been under pressure from lawmakers on both sides of the aisle over the shortages. Sen. Dick Durbin (D-IL) penned a letter to Califf last week expressing his concern and the action that he plans to take.

As a result of nationwide shortages of critical cancer drugs, providers are struggling to supply medications to even their sickest patients—denying or delaying care for others.

“I urge FDA to take immediate action to alleviate the burden on patients and providers caused by shortages of critical cancer drugs. The agency should use its authority to allow for the safe importation of these drugs from other countries, work with manufacturers to extend expiration dates if safe and appropriate on existing supplies of the drugs, regularly provide clear and timely updates to providers on expected timelines for additional supply, and ensure expedited inspections and reviews to assist in resolving this shortage,” the letter says.

FDA to import versions of common cancer drug to alleviate shortage

FDA to import versions of common cancer drug to alleviate shortage The FDA is hoping its latest solution will stave off the continued shortage of cisplatin, a key drug used in tre...