Certain pharmaceutical manufacturers and distributors of an investigational drug under an investigational new drug (IND) application must make their policies for evaluating and responding to requests under an expanded access program “public and readily available” by the end of this week pursuant to section 3032 of the 21st Century Cures Act (Cures). Cures, which became effective on December 13, 2016, provided a deadline for making the policies available on the later of: (i) 60 days after the enactment of Cures, or (ii) the first initiation of a phase 2 or phase 3 study with respect to the investigational drug. Therefore, the 60-day deadline expires on Saturday, February 11, 2017, for those manufacturers and distributors who are already conducting a phase 2 or 3 study under an IND. Continue reading
Category Archives: Clinical Trials
Deadline Looms for Pharmaceutical Manufacturers and Distributors to Comply with New Expanded Access Program Reporting Requirements
JAMA: Study Shows “Significant Positive Progress” in Managing Conflicts of Interest Among IRB Members, But More Work Needed
JAMA Internal Medicine published a report this week titled, Industry Relationships Among Academic Institutional Review Board Members: Changes From 2005 Through 2014, which is an update to a similar study conducted in 2005. The study found that although there were no significant changes in the percentage of institutional review board (IRB) members with an industry relationship, the number of respondents who stated that they always disclose industry relationships increased significantly from 54.9% in 2005 to 80.0% in 2014. IRB members also reported a decrease in instances where they felt another IRB member did not properly disclose a financial relationship and pressure from their institution or department to approve a protocol. Nevertheless, there was not a significant change among the number of IRB members who voted on protocols in which they had a conflict of interest, leading the study authors to conclude that additional work is needed to ensure that IRB members are educated on what constitutes a conflict of interest and to deter IRB members from inappropriately voting on protocols in which they have a conflict.
The National Institute of Health (NIH) recently released its final policy related to sharing human and non-human genomic data (GDS Policy). The GDS Policy applies to all NIH-funded research, regardless of the level of funding, that generates large-scale human or non-human genomic data, including the use of the data for subsequent research. The effective date of the GDS Policy is (i) grant applications with due dates on or after January 25, 2015; (ii) contracts submitted on or after January 25, 2015; and (iii) intramural research projects generating genomic data on or after January 25, 2015. In conjunction with the GDS Policy, NIH also released supplemental information regarding the scope of the GDS Policy.
On July 24, 2013, the Pharmaceutical Research and Manufacturers of America (PhRMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) announced joint endorsement of the “Principles for Responsible Clinical Trial Data Sharing: Our Commitment to Patients and Researchers.” These principles applicable to biopharmaceutical companies take effect January 1, 2014.