Wednesday, August 5, 2015
FDA seeks help from stakeholders on direct electronic source data to EDC
The FDA’s Office of Scientific Investigations has issued a warning letter to Paris-based AB Science, a pharmaceutical company that targets cancer and other diseases with high unmet medical need, for compromising the safety of study participants by failing to properly monitor its clinical trials and ensure investigators follow protocol requirements.
The FDA released a list of eight new conditions that it plans to assess during the next two years as part of its Patient-Focused Drug Development (PFDD) program. The program seeks to inform regulatory decision-making by soliciting patients’ perspectives on their diseases, treatment options and preferred endpoints for experimental therapies.
The U.S. House of Representatives has approved H.R. 6, the 21st Century Cures Act, by a vote of 344-77 and now goes to the U.S. Senate for consideration. This legislation would reauthorize the National Institutes of Health, focus efforts to increase strategic investments and medical research at the NIH and modernize the approval and regulatory process for new drugs, biologics and medical devices at the FDA. On May 21, 2015, the bill passed the House Energy and Commerce Committee by a vote of 51–0.
Last week, academic researcher Dong- Pyou Han was sentenced to four years and nine months in federal prison for falsifying HIV research data. Han also was required to repay $7.2 million in grant funding to the National Institutes of Health (NIH). This sentence is considered extreme given historical precedents for academic research misconduct.
U.S. Representative Billy Long has introduced legislation to update regulations guiding how drug manufacturers communicate product information.
Seeking to force faster disclosure of clinical trial data that helped Gilead Sciences win approval for two blockbuster hepatitis C drugs, two public health advocacy organizations filed a lawsuit against the FDA last month—the latest legal action where researchers and patient advocates have scuffled with drug makers and regulators over access to such information.