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Mar 03, 2008
 |  BioCentury  |  Regulation

Safety first at FDA

Regulation

Safety first at FDA

FDA's new Safety First initiative will focus at least as much attention on postmarket safety as the agency devotes to premarket reviews, and drive regulators to publicize drug safety signals before knowing what they mean and without any clear guidance on how doctors and patients should respond to the information.

As it looks for safety issues more intensely, FDA will uncover more concerns, Janet Woodcock, deputy commissioner and CMO, told reporters after a House hearing on drug safety last week. The agency will also communicate these concerns more rapidly and more frequently, she said.

How the agency communicates about risk will be closely scrutinized, but initial signals from senior agency officials and comments from members of the agency's new Risk Communication Advisory Committee (RCAC) last week suggest the regulators will attempt to portray risk in the context of the benefits provided by a drug or device.

At the same time, the additional work associated with pursuing new safety authorities mandated by the Food and Drug Administration Amendments Act of 2007 (FDAAA) and the new Safety First initiative looks certain to slow the speed at which new drugs are approved, as the agency has given its reviewers the leeway to miss user fee deadlines under the PDUFA IV agreement and to deny meeting requests(see Cover Story).

Defining turf

The basic components of Safety First include clearly delineating the roles of the Office of New Drugs (OND) and the Office of Surveillance and Epidemiology (OSE), creating new safety positions and procedures at OND, and formalizing communications about safety issues.

Disagreements and turf battles between OSE and OND have been highlighted by whistleblowers inside the agency who have been bringing their drug safety disputes to Congress.

According to an internal memo from Woodcock to the staff at the Center for Drug Evaluation and Research (CDER), a Safety First steering committee has given OSE "an expanded role in the resolution of certain drug-related safety issues," as well as "lead regulatory responsibility for areas related to observational epidemiologic studies and medication error prevention, including proprietary name review and review of carton and container labeling and packaging."

OSE will be given additional resources to pursue its remit, according to the memo.

While OSE is being given more authority, Woodcock told reporters, Safety First ensures that assessments of benefits and risks...

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