Legal experts question FDA guidance on new risk information

Legal experts contacted by BioCentury questioned whether FDA draft guidance released on Friday will achieve the agency's goal of enabling manufacturers to provide health care practitioners with greater access to emerging risk information. Sidley Austin's Coleen Klasmeier said the guidance limits new information to that appearing in studies and analyses published in peer-reviewed journals and noted that the peer review process is "notoriously long." Richard Samp, chief counsel at the Washington Legal Foundation, noted that FDA could face a First Amendment challenge by limiting what manufacturers "are permitted to say about safety concerns posed by products they manufacture." He noted that unless FDA can show material being distributed is untruthful, the agency has no basis for restricting distribution (see BioCentury Extra, June 6). ...