A group of researchers in Boston has taken the FDA to task for what it says is a set of policies that leaves drug safety data hidden in shrouds when it should be widely publicized. They called on the agency to create a new process that would push data out into the public so that analysts can review the data and help physicians determine the safest way to prescribe drugs. Safety data can be released on the FDA's website, they say, while proprietary chemical data on composition and efficacy can be kept secret to protect a drug developer's IP rights.
"Balanced against the need to protect companies' investments in drug development, however, is the risk that withholding this information can frustrate evaluation of drug safety," the authors wrote.
- read the report on the safety initiative from The Boston Globe