FDA policing researchers enough?

Not to be outdone by Democrats calling for pharma-related investigations by the Government Accountability Office, two Republican Congressmen are asking the GAO to probe the FDA's methods for disciplining researchers who break drug-trial rules. Rep. Joe Barton and John Shimkus wrote a letter to the government auditor, saying that FDA oversight of trials needs to be reviewed.

Barton alleged in a statement that the FDA "has waited months and sometimes years to take action against doctors who lied about their work" and suggests that the agency should use its authority to disqualify any "liars" from participating in drug studies. The two men also want the GAO to determine whether the FDA does enough to identify researchers "whose practices or conduct may compromise" trial data.

- see the item at Pharmalot

Suggested Articles

Bayer's new Vitrakvi for tumors with NTRK gene fusions is meeting skepticism in England and Germany, where cost watchdogs on Friday rejected it.

Hengrui's Sun Piaoyang is stepping down as chairman, but he'll retain control of the pharma major he's headed for 30 years—and made a fortune…

Astellas tapped Adaptimmune to develop T-cell therapies. Ireland hit Takeda with an unexpected Shire tax bill. PD-1 med Tyvyt hit its goal in NSCLC.