> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Rubio Questions Decision on Cisplatin Imports
- URL: https://www.fdaweb.com/rubio-questions-decision-on-cisplatin-imports/
- Published: 2023-06-22T12:00:00.000Z
- Updated: 2026-09-14T18:40:35.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154751

Senator **Marco Rubio** has written FDA commissioner **Robert Califf** to question the agency’s decision to temporarily permit the importation of unapproved cisplatin, an important chemotherapy drug in short supply in the U.S., from China’s Qilu Pharmaceutical. “As the FDA works to alleviate these shortages, it must carefully consider the health and safety consequences of foreign drugs it is allowing into the country,” Rubio wrote in the [6/21 letter](https://www.floridadaily.com/marco-rubio-why-is-fda-allowing-an-unproven-chinese-cancer-treatment-to-be-imported/?ref=fdaweb.com). “I am concerned that the FDA’s solution to this problem, so far, is to import more drugs from the \[People’s Republic of China\] PRC, an adversary with a poor health and safety record.”

Rubio said there are many concerns with FDA’s decision. “According to the FDA’s database, the last time the FDA inspected and gave Qilu a passing grade was December 2019 — nearly four years ago, and before the pandemic,” he wrote. “A separate review by the European Medicines Agency (EMA) found 30 deficiencies in Qilu’s production of active pharmaceutical ingredients (APIs) for an antibiotic, resulting in the EMA implementing special measures to oversee production. Despite this previous incident, the FDA has given no indication what specific product quality measures Qilu will have to meet.”

Additionally, Rubio’s letter asked FDA to answer a number of questions. They are:

- What criteria did FDA use to evaluate Qilu as the best and safest manufacturer to import cisplatin?
- When was the most recent date that FDA completed an inspection of Qilu Pharmaceutical facilities?
- Why did FDA decide to import cisplatin from a Chinese company instead of an allied country?
- What other pharmaceutical manufacturers were considered in FDA’s search for an alternative foreign supplier?
- Does the agency intend to request additional foreign manufacturers to temporarily supply the U.S. with cisplatin?
- Does FDA intend to import carboplatin and methotrexate, two other chemotherapy drugs experiencing a shortage, from Qilu Pharmaceutical or other Chinese manufacturers?