Biotech companies now have a new master when it comes to reporting about their clinical trial to U.S. regulators. Health and Human Services Secretary Kathleen Sebelius has punted the sometimes-controversial responsibility for oversight of clinical trial reporting to the FDA. Transparency of clinical data has been a hot topic in the biotech industry in recent years.
According to a posting today in the Federal Register, the FDA, which reports to HHS, now must determine whether there was any required clinical trial information that hasn't been submitted and give the "responsible party" 30 days to get the data into the federal clinical trials registry.
Concern over whether academic and industry researchers are providing everything they should when it comes to their clinical trials, bad reports along with positive, has been percolating in recent years. The $3 billion settlement that GlaxoSmithKline ($GSK) recently paid included the finding that it allegedly failed to report safety data on its controversial diabetes drug Avandia. That included leaving out two studies specifically designed to gauge the drug's safety.
The National Institutes of Health last year issued new rules requiring investigators to detail any financial ties (whether cash or stock) they have with biotech, pharma and medical device companies exceeding $5,000 in value. The federal officials ditched a proposed requirement to post the ties online for public review.
Last month, Democrats in the House proposed changes to the U.S.' clinical trial registry that would impose stronger reporting requirements and mandate that foreign studies meet the same standards as domestic ones if they're conducted for FDA approval.
The Federal Register notice also says the FDA can redelegate the authority.
- here is the Federal Register notice (PDF)
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