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Possible FDA shutdown may affect drug approval for Korean pharma companies
  • By Lee Han-soo
  • Published 2018.12.21 17:29
  • Updated 2018.12.21 17:29
  • comments 0

Korean pharmaceutical companies waiting for approval or applying for a new drug candidate may have to wait, as the U.S. Food and Drug Administration may shut down on Friday.

FDA, along with various other federal government agencies, may shut down if the U.S. President Donald Trump and Congress fail to pass the federal funding bills until midnight on Friday. The possibility of the shutdown comes after the budget fight between the President and Congress regarding Trump’s demand for $5 billion to fund a wall along the U.S.-Mexico border.

The U.S. Senate tried to pass a continuing resolution, a short-term spending bill, without the fund for the wall but was thwarted as Trump announced that he would not sign the bill.

According to press reports from Washington, a shutdown seems likely as Democrats have said they will not vote for additional border funding.

According to the Department of Health and Human Services’ contingency plans, if a shutdown takes place, the FDA will remain operational but the agency’s work speed will slow down as about 7,053 FDA staff, or 41 percent of the total, will be furloughed without pay if the shutdown occurs with only the remaining 10,344 continuing their work.

The contingency plan states that the FDA would be unable to support some routine regulatory and compliance activities.

“This includes some medical products, animal drugs, and most food-related activities. FDA will also suspend routine establishment inspections, cosmetics and nutrition work, and many ongoing research activities,” the plan says.

An expert has already urged pharmaceutical companies to apply for a new application as soon as possible.

“Any drug company that wants to file a new application should do so quickly,” said Steven Grossman, deputy executive director of the Alliance for a Stronger FDA, a nonpartisan advocacy group, to “Stat,” a health-oriented news website. “This is ‘just in case,’ because in the past there was a distinction between product reviews on which fees were paid and those on which fees were not paid at the time of the shutdown.”

Grossman also noted that after the new Congress starts on Jan. 3, all bills from the previous Congress are wiped out and will need to be reintroduced and acted upon, which may take some time.

The possibility of an FDA shutdown has raised uncertainties for local pharmaceutical companies that are currently conducting clinical trials in the U.S.

“Last time the FDA shut down, the company I previously worked for had problems submitting its end of trial declaration and clinical trial summary report to the FDA,” said a spokesperson currently working for a company that is conducting clinical trials for its immunotherapy in the U.S., asking to remain anonymous.

“The shutdown can also affect companies planning to start their clinical trials as they may not be able to report to the FDA that they have finished patient recruitment,” he told Korea Biomedical Review over the phone.

Also, the shutdown may postpone the plans of several pharmaceutical companies that had scheduled to finish their clinical trials by the end of this year or during the start of next year, the official said, “Many local pharmaceutical companies might be embarrassed if the FDA shutdown becomes a reality,” he added.


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