The Department of Health and Human Services is passing the unenviable responsibility of keeping CROs and pharmas honest to the FDA, and the agency will now be in charge of making sure clinical trial reporting is accurate and transparent.
As the Federal Register recently disclosed, HHS Secretary Kathleen Sebelius has delegated to the FDA the task of determining whether trial-runners have left out any data in their disclosures and giving them 30 days to rectify any omissions. The law requires outfits that conduct clinical trials to report their results, and the resulting public information is available on the federally operated ClinicalTrials.gov.
Of course, pharmas and CROs haven't always been compliant with transparency regulations, and the FDA will now be in charge of ensuring against events like GlaxoSmithKline's ($GSK) Avandia debacle, in which the company failed to report safety data on the drug.
Some argue that existing regulations don't go far enough to ensure clinical trial honesty. In August, House Democrats introduced a bill 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. However, the Trial and Experimental Studies Transparency Act remains in committee, and it's unclear whether it will garner support in the Republican-controlled House.
Last year, in an effort to increase trial transparency, the National Institutes of Health issued new rules requiring investigators to disclose any financial ties, cash or stock, they have with biotech, pharma and medical device companies exceeding $5,000 in value.
- here's the Federal Register notice (PDF)
- read FierceBiotech's take