Conflicts of Interest
By Kate Greenwood Cross-Posted at Bill of Health A week ago, the Food and Drug Administration announced the results of a review of the medical literature it conducted in response to “recent reports questioning the safety of prescription and over-the-counter (OTC) pain medicines when used during pregnancy.” The literature, FDA determined, is inconclusive. FDA found […]
By Jordan Paradise This week, the New York Times reported that ophthalmologists who were paid to promote Genentech’s drug Lucentis (ranibizumab) were among the top billers of the drug to federal programs, exceeding the prescribing amounts of more than 75% of their peers. Lucentis, approved in 2006 by the Food and Drug Administration (FDA), is indicated […]
When we think about health care reform, we need to remember that we have been attempting reforms through many avenues of myriad parts of our health system. The IRS revised Form 990 and schedule H in anticipation of the ACA; critics of conflicts of interest have been working on multiple fronts simultaneously. One of the […]
The NIH’s Amended Conflict of Interest Regulations: A New, Weaker Approach to Intellectual Property Interests?
Yesterday, at long last, the National Institutes of Health released the final revisions to its regulations governing financial conflicts of interest on the part of applicants for federal research funds. And there is good news. The rule’s sunshine provisions have not, as was feared, been “gutted.” Grant recipients will have to make their investigators’ financial […]
…After the Horse Has Already Left the Barn: FDA Continues to Postpone Conflicts Review Until Studies Are Complete
On Tuesday, the Food and Drug Administration released a draft guidance on financial disclosure by clinical investigators, targeted at the investigators themselves, at drug and device companies and others who sponsor clinical trials, and at the agency staff who review the disclosures. In the draft guidance, which updates an earlier one, the FDA briefly reviews […]