Hello? Anyone out there? I send out a group email and get back scores of automated replies thanking me for my email and telling me when the recipient will be back in the office. I feel like the only person who isn’t at the beach, in the mountains and enjoying these last days of summer. In the event there are other lone souls like myself, I am sending you this week’s Weekly Roundup.
- Meeting on Women and Minorities in Clinical Trials – I have attended dozens and dozens of AdComm meetings and read even more transcripts and viewed recordings of the proceedings. One of the most frequent questions that comes up involves what kind of efforts the drug sponsor undertook to recruit minorities into the clinical trials. The answer is almost invariably the same – advertisements. On this blog, I have often been a proponent of using patients to recruit patients through the use of video and YouTube. Now the FDA has announced a long overdue meeting on the topic called “Dialogues in Diversifying Clinical Trials: Successful Strategies for Engaging Women and Minorities in Clinical Trials.” The agency says that the purpose of this symposium is to facilitate the broader discussion and dissemination of innovative strategies for increasing the recruitment and retention of women and minority subpopulations into clinical trials. The meeting will be held in Washington on September 22 and 23.
- FDA Approves New Melanoma Treatment – This week the agency approved Zelboraf (vemurafenib), a drug to treat patients with late-stage melanoma. According to the FDA’s release “Zelboraf is specifically indicated for the treatment of patients with melanoma whose tumors express a gene mutation called BRAF V600E. The drug has not been studied in patients whose melanoma tests negative for that mutation by an FDA approved diagnostic. Zelboraf is being approved with a first-of-a-kind test called the cobas 4800 BRAF V600 Mutation Test, a companion diagnostic that will help determine if a patient’s melanoma cells have the BRAF V600E mutation. The BRAF protein is normally involved in regulating cell growth, but is mutated in about half of the patients with late-stage melanomas. Zelboraf is a BRAF inhibitor that is able to block the function of the V600E-mutated BRAF protein.” The drug is made by Genentech and the diagnostic companion by Roche Molecular Systems.
- FDA Issues Strategic Plan for Advancing Regulatory Science – And speaking of innovation, the FDA released this week a strategic plan to modernize the science behind the consideration and approval of new medical products. The plan covers 8 priority areas: (1) Modernizing Toxicology to Enhance Product Safety (2) Stimulating Innovation in Clinical Evaluations and Personalized Medicine (3) Supporting New Approaches to Improve Product Manufacturing and Quality (4) Ensuring FDA Readiness to Evaluate Emerging Technologies (5) Harnessing Diverse Data through Information Sciences to Improve Health Outcomes (6) Implementation of a New Prevention-Focused Food Safety System (7) Facilitation of Development of Countermeasures to Protect Security and (8) Strengthening Social and Behavior Sciences to Help People Make Informed Decisions. These priority areas are all indeed important and the sentiment behind the plan is indeed ambitious. But the agency is large and difficult to steer and will be greatly challenged in the coming months by budgetary changes coming to us all. The strategic plan is a great first step, but it is only a first step and clearly the much bigger and arduous task for the FDA is in the implementation.
That’s it from this lonesome cowboy…. Have a good weekend everyone – wherever you are.
The strategic plan is a great first step, but it is only a first step and clearly the much bigger and arduous task for the FDA is in the implementation.