On Thursday, Representatives Henry Waxman (D-Calif.) and Edward Markey (D-Calif.) introduced legislation which would require that pharmaceutical companies and medical device manufacturers disclose more information about the clinical trials they sponsor. The Fair Access to Clinical Trial (FACT) Information Act would require organizations sponsoring research to turn over information both before and after trials. Companies would be required to submit information on outcomes, adverse events and other key data.
Critics have long argued that pharmaceutical companies in particular are highly selective in the information which they make public, a practice which can present a distorted picture of the science underlying much research. Industry backers have countered that information is already made public on a voluntary basis, and that requiring full disclosure would flood the system with data.
- see this press release from the office of Rep. Henry Waxman (pdf)