1 in 5 FDA scientists had drug concerns

WASHINGTON – Almost one-fifth of Food and Drug Administration scientists surveyed two years ago as part of an official review said that they had been pressured to recommend approval of a new drug despite reservations about its safety, effectiveness or quality.

The survey of almost 400 scientists also found that a majority had significant doubts about the adequacy of federal programs to monitor prescription drugs once they are on the market, and that more than a third were not particularly confident of the agency’s ability to assess the safety of a drug.

The results of the survey, conducted by the Health and Human Services Department’s inspector general, appear to support some portions of the controversial Senate testimony last month by FDA safety officer David Graham. The 20-year agency veteran told senators that the FDA was unable to keep some unsafe drugs off the market, and that scientists who dissented about drug safety and effectiveness were sometimes pressured and intimidated.

In the survey, 63 of 360 respondents – 18 percent – said they had been “pressured to approve or recommend approval for a (new drug application) despite reservations about the safety, efficacy, or quality of the drug.”