Van Hollen, Colleagues Urge FDA to Provide Answers on Coronavirus Impact on Inspections, Employees

Today, U.S. Senator Chris Van Hollen (D-Md.) and Senators Patty Murray (D-Wash.), Sherrod Brown (D-Ohio), Ben Cardin (D-Md.), and Mazie Hirono (D-Hawaii) wrote a letter to the U.S. Food and Drug Administration (FDA) Commissioner Stephen Hahn seeking information on the FDA’s plans for inspections in China, in light of the coronavirus outbreak. The FDA conducts a number of inspections in China to ensure the quality and safety of food, pharmaceuticals, and medical devices entering the United States. While inspections are currently suspended, should they resume, FDA’s compliance and inspection personnel would be sent to China to conduct them. The Senators are requesting the FDA provide information on the agency’s plans for resuming inspections and protecting the health and safety of its workers, many of whom are Maryland constituents.

In their letter the Senators say, “We write today to request information about your agency’s plans for FDA inspections in China in light of the outbreak of a new coronavirus, COVID-19, first identified in Wuhan City, Hubei Province, China, and the serious potential health risk the outbreak could pose to FDA’s compliance and inspection personnel. Additionally, we strongly urge you to establish open lines of communication with your workers and their union representatives now, as you make plans to resume inspections in China. FDA employees deserve a seat at the table as agency leadership has discussions and develops policies related to inspections in China.”

They continue, “As you know, FDA’s workers, including its compliance and inspection personnel, play a critical role in carrying out the agency’s mission to protect the public health. FDA’s compliance and inspection personnel are on the front lines ensuring that our food is safe and properly labeled and that our pharmaceuticals and medical devices are safe and effective. Inspection activities in China have been suspended but pose a potential risk to FDA workers when activities resume.”

The Senators close the letter requesting a number of answers regarding plans around inspections and communications with FDA employees on these plans. The full text of the letter can be seen here and below.

Dear Commissioner Hahn,

We write today to request information about your agency’s plans for FDA inspections in China in light of the outbreak of a new coronavirus, COVID-19, first identified in Wuhan City, Hubei Province, China, and the serious potential health risk the outbreak could pose to FDA’s compliance and inspection personnel. Additionally, we strongly urge you to establish open lines of communication with your workers and their union representatives now, as you make plans to resume inspections in China. FDA employees deserve a seat at the table as agency leadership has discussions and develops policies related to inspections in China.

As you know, FDA’s workers, including its compliance and inspection personnel, play a critical role in carrying out the agency’s mission to protect the public health. FDA’s compliance and inspection personnel are on the front lines ensuring that our food is safe and properly labeled and that our pharmaceuticals and medical devices are safe and effective. Inspection activities in China have been suspended but pose a potential risk to FDA workers when activities resume.

The FDA must protect the health and safety of its workers while carrying out its important mission. In order to better understand your agency’s plans around future inspections and efforts to protect the health and safety of your workers in China, we ask that you provide responses to the below questions by March 13, 2020:

1. Are there any near-term plans to resume sending any FDA employees, including compliance or inspection personnel, to China?
1. If yes, when does FDA plan to resume sending those employees and when does it plan to resume inspections? Please detail the scope and frequency of inspections that will be resumed.
2. FDA has stated that inspection-related travel to China that is deemed to be mission-critical will be assessed on a “case-by-case basis.”[1] Does FDA have any established protocol for those decisions? If so, please provide details on that protocol.
3. How much notice does FDA plan to give compliance and inspection personnel before resuming inspections in China? Has FDA done any work, on its own or in coordination with the Centers for Disease Control and Prevention (CDC), the Occupational Safety and Health Administration (OSHA), or any other agency, to begin developing health and safety protocols for FDA inspectors once inspections in China resume?
1. If yes, please detail this work.
2. If no, please detail why such work has not been initiated and when FDA plans to begin this work.
4. How is FDA communicating information and/or policies related to inspections in China to its workers and/or union representatives? Please provide any such communications (including written and electronic communications), the date of the communication, how the communication was distributed, and to whom it was distributed.

Thank you in advance for your attention to this important matter. We look forward to hearing from you.

Sincerely,

[1] FDA Statement, FDA’s Actions in Response to 2019 Novel Coronavirus at Home and Abroad (Feb. 14, 2020), available at https://www.fda.gov/news-events/press-announcements/fdas-actions-response-2019-novel-coronavirus-home-and-abroad.