FDA seeks to ramp up transparency, media outreach

WASHINGTON: As the Food and Drug Administration (FDA) pledges to increase transparency of how it monitors drugs, it has also begun greater public and media outreach.

WASHINGTON: As the Food and Drug Administration (FDA) pledges to increase transparency of how it monitors drugs, it has also begun greater public and media outreach.

The FDA is looking to diffuse internal and external criticism over whether it can adequately monitor drugs post-approval.

The agency, working with the Department of Health and Human Services (HHS), is still determining the type and extent of information to disclose by seeking suggestions from patients and doctors.

"We would like a lot of input, particularly from patient and provider groups," said FDA press officer Brad Stone.

The FDA will launch the initiatives over the next few months with a series of public and media events, Stone noted.

It is making officials such as HHS Secretary Mike Leavitt available to discuss the program, and is sponsoring events with patient and physician groups, he added.

The initiatives include a new independent Drug Safety Oversight Board that will monitor safety issues. Drug risks will be posted on a Drug Watch web page.

In addition, the FDA will prepare information sheets for both doctors and patients on drug risks.

"The office of public affairs as well as the office of external relations will play an important role in making people aware of these initiatives," Stone noted.

The October recall of Merck's arthritis drug Vioxx sparked questions about whether the FDA knew - or should have known - about the painkiller's heart risks, and whether it had adequately informed the public.

Fleishman-Hillard SVP Mark Senak, who counsels clients on bringing drugs to market, noted that the FDA is undergoing a shift in drug approval.

"For the FDA to look better ... they're going to need to crack down on industry," he said, adding that the agency will need to demonstrate that it is raising the bar on safety.

"The truth is, the FDA is much more transparent - as it existed before - than the European model," Senak added. "There's always been a commitment to transparency. I think that agenda's speeded up given these events."

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