NEW YORK (AP) The U.N. is trying to make the case for the use of plastic injection equipment in hospitals, but a federal judge on Friday rejected a request to require companies to disclose the extent of the evidence used to test equipment.
The U.C. Berkeley Center for Bioethics said in a court filing that it will sue to block the FDA’s order to disclose any information related to the process, known as “bioethics analysis,” which uses a series of tests to detect whether a particular drug or tissue is a candidate for biotechnology or has been approved.
The FDA says the Bioethicists Analysis Process is designed to “ensure that the public is not misled about whether a drug or a tissue is safe or effective.”
The Berkeley Center argues that the FDA has an important interest in protecting the public from the use and misuse of biotechnology and should not force companies to report their findings.
It also said the FDA is violating the First Amendment by requiring companies to provide information about the “procedure used to determine if a drug is safe, effective or safe to use.”