FDA Risk Management Tool: Physician Rapid Response Surveys

Physician rapid response surveys of physicians will help FDA make risk management decisions.

The surveys will "obtain data on safety information to support quick turnaround decision-making about potential safety problems or risk management solutions" for drugs, biologics or devices, a notice published April 30 in the Federal Register states.

The surveys will likely be designed to elucidate information on possible product risks that FDA has received through spontaneous adverse event reporting.

In addition to gathering information, the surveys could serve another one of the agency's risk management goals: generating awareness among physicians about potential safety issues with products.

FDA's request for clearance from the White House Office of Management and Budget "covers rapid response surveys for community-based healthcare professionals, general-type medical facilities, specialized medical facilities (those known for cardiac surgery, obstetric/gynecology services, pediatric services, etc.), other healthcare professionals, patients, consumers and risk managers working in medical facilities." The agency also plans to survey manufacturers.

"Participation in these surveys will be voluntary," FDA noted. The agency anticipates that the various centers would conduct a total of 30 surveys a year, with a sample size between 50 and 200 respondents each. The surveys would take about a half-hour to complete.

Once OMB approves the rapid response survey concept, FDA would submit specific surveys that would be quickly reviewed, usually within 10 days. Standard survey requests normally take nine months to be reviewed; FDA was concerned that the information collections would not be relevant by the time they were approved.

The rapid response surveys are based on a program initiated at the Center for Devices & Radiological Health.