PhRMA, BIO criticize FDA's journal guidance

The Pharmaceutical Research and Manufacturers of America and Biotechnology Industry Organization voiced concerns about FDA's June draft guidance on how companies can distribute journal articles that discuss new risk information for approved products.

Both stressed manufacturers' First Amendment rights to distribute truthful, non-misleading information. PhRMA urged FDA to allow dissemination of new information about approved drugs' efficacy as well as risk, using comparable standards of substantiation for both. ...