SAN DIEGO, March 28, 2011 /PRNewswire/ -- By tracking the use and side effects of a medicine, biotechnology companies can help physicians prescribe those medicines more safely and effectively, as proven in a study released today by BIOCOM, the life sciences trade association representing Southern California. Safety First: The Role of Physician Level Data in Supporting Risk Evaluation and Mitigation Strategies (REMS) for Optimal Patient Care—A Case Study documents the use of physician level data by Amylin Pharmaceuticals (a BIOCOM member) in relation to SYMLIN, a life-changing medication for certain people with diabetes. Use of physician level data for SYMLIN is critical in meeting the Food and Drug Administration's risk mitigation requirement. The report outlines how Amylin is using physician level data to:
- Negotiate with the FDA to determine which approaches and tactics were feasible
- Identify physicians skilled in the art of prescribing mealtime insulin—22,000 physicians from a universe of more than 400,000 health professionals who treat type 1 and type 2 diabetes
- Disseminate information and provide support for optimal patient care to selected physicians
- Monitor prescribing patterns on an ongoing basis to identify SYMLIN prescribers outside the original list and provide them with information and support
- Create ongoing dialogue with physicians regarding safety and appropriate use
Despite the benefits, some legislators have proposed measures in several states that would make this drug data unavailable.
"Many pharmaceutical and life science companies use physician level data, which by law cannot identify specific patients, to identify physicians for outreach and education efforts," said Joe Panetta, President and CEO of BIOCOM. "This data allows these companies to deploy resources to physicians in a very targeted manner so that their patients receive the best monitoring and care standard," Panetta said. "This report seeks to inform that conversation by giving a real world example of how a company worked with the FDA to develop a strategy using this information to maintain a high level of safety and efficacy for this drug," he said.
The report can be found at: http://www.biocom.org/?m=sp_view_doc&file=Shared%20Documents/Public%20Policy/MD_level_data_rpt.pdf
About BIOCOM: BIOCOM is the largest regional life science association in the world, representing more than 550 member companies in Southern California. The association focuses on initiatives that positively influence the region's life science community in the development and delivery of innovative products that improve health and quality of life. This includes initiatives in capital formation, public policy, workforce development, group purchasing and member services such as networking events. For more information on BIOCOM or the Southern California biotechnology and medical device community, please visit www.biocom.org.