FDA’s LDT Rule Puts Pressure On Congress To Act, Cassidy Alleges Rule Is Illegal

FDA on Friday (Sept. 29) unveiled its long-anticipated proposal to assert regulatory jurisdiction over laboratory developed tests, and the move immediately sparked protests from the Senate health committee’s ranking Republican that the agency is overstepping its statutory authority. “The FDA does not have the authority to unilaterally expand its regulatory jurisdiction. We saw during the pandemic how too much government interference and red tape could do more to delay lifesaving care,” said health committee ranking Republican Bill Cassidy (LA) ...