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Florida expands lawsuit on release of FDA records related to Canada drug imports

fda
AP
The issue stems from a proposal that the Florida Agency for Health Care Administration submitted in November 2020 to the FDA to import cheaper prescription drugs from Canada for state programs such as Medicaid, the prison system and facilities run by the Department of Children & Families.

The state alleges the federal agency violated the Freedom of Information Act. The revised lawsuit includes allegations that the FDA did not properly respond to a records request submitted in May.

The state filed a revised lawsuit Monday adding to allegations that the U.S. Food and Drug Administration has not properly provided records about Florida’s attempt to get approval for a program to import prescription drugs from Canada.

The filing expanded a lawsuit the state filed in April alleging the federal agency violated the Freedom of Information Act. The revised lawsuit includes allegations that the FDA did not properly respond to a records request submitted in May.

The issue stems from a proposal that the Florida Agency for Health Care Administration submitted in November 2020 to the FDA to import cheaper prescription drugs from Canada for state programs such as Medicaid, the prison system and facilities run by the Department of Children & Families.

At least initially, the state wants to import drugs to treat conditions such as HIV and AIDS, hepatitis C, diabetes and mental illness, according to court documents. The FDA would need to approve the program but has not made a decision.

The state in 2022 filed a lawsuit alleging that the FDA violated a law known as the Administrative Procedure Act and the Freedom of Information Act. It filed a separate Freedom of Information Act lawsuit in April and the revised version of that lawsuit Monday.

The Administrative Procedure Act lawsuit centers on delays in decision-making about the state’s proposed program. In a court filing last week, the FDA reiterated an earlier statement that it expects to issue a decision by Oct. 31.

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