Duval Times

U.S. Senator Marco Rubio (R-FL) and a group of his colleagues have raised concerns about the U.S. Food and Drug Administration's (FDA) standards for foreign drug and medical device production. In a letter addressed to FDA Commissioner Robert Califf, the senators criticized the agency's lax and infrequent inspections of foreign facilities and requested information about plans to increase the frequency of inspections abroad.

According to the letter, the FDA completed only eight inspections of Chinese drug manufacturers and zero inspections of Chinese device manufacturers in 2022. In contrast, the agency conducted 897 inspections of domestic drug manufacturers and 1,706 inspections of domestic device manufacturers during the same period. This discrepancy raises concerns about the safety and quality of drugs and devices imported from foreign countries.

The senators argue that the FDA's current approach puts Americans at risk of drug shortages and endangers their health. They believe that foreign manufacturers should be held to the same high standards as domestic producers in order to ensure the safety of patients and maintain a level playing field for American industry.

One example cited in the letter is the recall of 32 million Chinese syringes by Cardinal Health due to a manufacturing error that could have caused patients to overdose or underdose. Another case involved the recall of valsartan, a drug commonly used for high blood pressure and heart failure, because of contamination from a manufacturing process change in China. These incidents highlight the potential dangers of relying on low-quality and unsafe drugs and devices from abroad.

In light of these concerns, the senators have posed several questions to the FDA Commissioner. They want to know why there were zero inspections of foreign medical device manufacturers in 2022 and how many inspections the FDA plans to conduct in 2023 and 2024. Additionally, they ask how the FDA can guarantee that drugs and devices manufactured overseas meet the same standards as those produced in the U.S. and what steps the agency is taking to increase the number of foreign inspections.

The senators emphasize the importance of ensuring the safety and quality of drugs and devices, regardless of their country of origin. They assert that foreign manufacturers should be subject to the same rigorous standards as domestic producers to protect American patients and prevent unfair competition in the global market.

The FDA has yet to respond to the senators' letter, but they anticipate a prompt response.

To find out more, go to this link: https://www.rubio.senate.gov/rubio-colleagues-question-fda-standards-for-medical-manufacturing-inspections/