In an attempt to counter-balance calls from consumers, physicians and scientists that the FDA open up its books and let the sun shine on its oversight of clinical trials, flagging devices and drugs for safety reasons and airing dissenting opinions, the national medical device industry council said any “confidential, commercial and trade secret information” submitted to the federal watchdog should be kept under lock and key.
The testimonials were part of a public meeting in Washington, D.C., the FDA held on transparency.
While agreeing in principle that the agency’s decision-making process should be as open as possible AdvaMed vice president of regulatory affairs Janet Trunzo said the information the public now has access to is mostly adequate and any further opening of the books should be done carefully.
“We believe that under current law, the proprietary information submitted to the agency is adequately protected from disclosure and any legislative or regulatory undertakings to create greater transparency must respect the controls currently in place,” Trunzo said in a statement (attached below).
AdvaMed is still working on “detailed recommendations,” which it plans to release soon, she added.
The meetings are part of an effort to answer growing demand for more information about how the FDA conducts its business. It’s faced criticism over its ties to industry and that it hasn’t reacted quickly enough to safety issues with food, durgs and devices.