The FDA has gone easy on the leader of a clinic who allegedly submitted fake data in a drug trial. Physician Daniel Berger will continue his HIV drug trial work, but it will now be under the eye of an outside medical monitor.
The FDA had threatened to disqualify Berger from conducting trials. In similar cases in which it has sidestepped disqualification, the regulator placed limits either on the number of trials doctors can conduct, or on the number of patients they can enroll, reports the Chicago Tribune. Berger was saddled with neither; however, he is now required to submit annual reports to the regulator for the next three years.
In contrast to the light touch it used on Berger, the FDA is taking a much tougher stance on drugmakers who commit manufacturing violations. The agency is issuing more warning letters and is threatening executive prosecutions for repeat offenders.
Drug developers are receiving warning letters, too. Pfizer, as reported in April, got one for a second incident of excessive dosing in an antipsychotic drug trial. The drug giant cited inadequate training after the first incident. But a year later, the excessive doses were being given again.
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