The summer has ended. On Capitol Hill, however, the hot air continues to blow and blow hard regarding legislation aimed at reforming health care in the United States. Autumn has arrived and the time has come to plant the mums. I head to the mountains for a much needed respite.
- Dendreon Announces Regulatory Plans for Provenge – Regarding its much anticipated investigational candidate to treat men with prostate cancer – Provenge – Dendreon announced this week that the company is on track to file a BLA amendment to the FDA by the middle of November. In an earlier deliberation in 2007, an Advisory Committee voted in favor of the safety and efficacy of Provenge, but the FDA sent the company a Complete Response Letter asking for more data.
- Institute of Medicine to Examine PreMarket Clearance Process for Devices – In what is surely only to be one of many initiatives aimed at the regulation of devices in the months to come, the FDA announced this week that it is seeking a study from the IOM to review the 510(k) approval process. According to the release, the IOM will convene a committee to review the process and make recommendations whether it is in need of reform, and if so, what kind of reform. The report is due in 2011.
- FDA Enforcement Measures to Increase - At the Food and Drug Law Institute Conference held Monday and Tuesday in Washington, Tom Abrams, Director of DDMAC, stated that he expected FDA enforcement measures to increase and that the agency was resolved to closely regulate and react to marketing measures it deems in violation.
And the video of the week goes to FDA, for a short video that describes for consumers the recall process: