Happy Independence Day for America. This week also so Canada Day. So while a week where work productivity may have dipped, enjoyment factors probably drove up – at least in North America. The season is marked by hot, humid days and stormy nights, especially now as Hurricane Arthur takes an excursion along the Southeast coast in the Atlantic. So many things going on.
And here are few from this week that caught my eye related to FDA, pharma and communications:
- Accelerated Approval for a New Drug – Always noteworthy, FDA announced this week the accelerated approval of Beleodaq – a new treatment with orphan status for a type of Non-Hodgkin Lymphoma called peripheral T-Cell lymphoma (PTCL) – one of the ways in which lymph nodes can become cancerous – from Spectrum Pharmaceuticals. The drug works by stopping an enzyme that contributes to T-Cells becoming cancerous and is the third drug approved since 2009 for PTCL, according to FDA and FDA took the unusual step of listing those in this press release. Accelerated approval, it should be noted, allows approval based upon surrogate endpoints which would be reasonably likely to produce a clinical benefit. Accelerated approval is one of four designations that can alter the approval pathway timing and course and differs from Fast Track. Here is an FDA Web page that provides an overview of them. And here is the Guidance on Expedited Programs for Serious Conditions.
- More Information on Regulation of Compounders – In 2012 and throughout 2013, in response to highly publicized adverse events associated with compounded products, policy actions were taken to increase FDA’s authority over that sector resulting in a series of new steps to help define the environment regarding compounding. Eye on FDA has a tab for compiling a historical timeline of many of these actions. This week, FDA announced a series of steps to move the process along, including (1) a draft interim guidance on maintaining current Good Manufacturing Practices (cGMP); (2) a new proposed rule that would revise the list of drugs that may not be compounded; (3) a Final Guidance on the practice of compounding and regulatory actions related thereto; two Federal Register notices – one a list of bulk drugs that may be used in compounding according to one section of the regulations and another for a second section.
- Legal Actions – FDA announced two legal actions that provide insight into different regulatory oversight – the first was against a California company in which the agency was seeking a permanent injunction because FDA said was selling products that were actually over-the-counter (OTC) drug products without approval. The second action related to a dietary supplement manufacturer where the agency obtained a consent decree due after the agency issued warnings about a product being sold that contained ingredients in the form of controlled substances that were not included in the ingredient label.
Time to fire up the grill! Happy Independence Day to U.S. readers; Happy Canada Day to Canadian readers and the rest of you – have a wonderful weekend.
