The agency announced proposed research studies on how healthcare providers and patients understand drug promotional materials.
On March 12, 2018, FDA announced it was proposing research studies to be conducted by the Office of Prescription Drug Promotion to gain information on how risk and benefit information is understood by healthcare providers and patients. This research will be used to help the agency develop guidelines on disclosure of risk information in advertising.
FDA also published a notice in the Federal Registerabout the purpose and role of social science in prescription drug promotion policy. A proposed study on the Utilization of Adequate Provision among Low to Non-Internet Users will “evaluate methods for how certain consumers can gain access to the full approved drug package labeling to help ensure that they are well-informed about a drug’s risks and benefits,” according to the agency.
"The FDA has prioritized a robust social and behavioral science research program to help us understand how people make decisions about the products we regulate. This includes research surrounding how patients and health care providers understand prescription drug benefit and risk information in promotional materials. This research has provided key information to inform our policies related to the proper regulation of prescription drug advertising,” said FDA Commissioner Scott Gottlieb, MD, in a press release. “Most recently, our research on how drug risks are presented in TV ads suggested that a more targeted presentation of risks may lead to better retention of the potential side effects that consumers should weigh as they consider their treatment decisions. As a result, we’ve been exploring new guidelines that would recommend more focused disclosure of risk information in TV ads, to better emphasize potential side effects that are severe, serious and actionable. I’m committed to continuing to invest in this critical research to help ensure we’re making informed, science-based decisions. To achieve these goals, we recently announced several additional research projects that can help us understand other important aspects of promotional communications. This includes the effectiveness of disclosures, communications aimed at health care providers and consumer understanding of the accelerated drug approval process."
Source: FDA
Trump Directs FDA, EPA to Reduce Regulatory Barriers to Domestic Pharma Manufacturing
May 7th 2025The White House is instructing FDA to increase fees for and inspections of foreign drug manufacturing plants and reduce the time required to approve such sites that will be newly constructed in the US.
New Cancer Research and Treatment Center in Development in London
May 1st 2025Aviva Capital Partners and developer Socius are investing £1 billion in a 12-acre site to be located at the London Cancer Hub next to The Institute of Cancer Research, London and The Royal Marsden NHS Foundation Trust’s Sutton site.
Regeneron Treatment for Multiple Myeloma Gets Conditional Marketing Approval from EC
April 29th 2025The indication is specific to patients who have received at least three prior therapies, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.