The snow has melted and the ground is soggy. Looking at the ground there are daffodil tops poking out of the dirt and this morning on my dog walk, I spotted my first two crocus blooming purple. The volume of birdsong has definitely increased. And I find myself in moments where there is a quick mental break, with a wandering mind considering the scheduling and destinations of spring vacations. Daylight savings is just 16 days away…
In the meantime, it looks like it was a fairly eventful week and here is a bit of what happened:
- Supply Chain Pilot Program for Drugs Launched – In August 2013, FDA published a notice in the federal register seeking pharmaceutical company participation in a pilot program aimed at bolstering the security of the supply chain for drugs imported into the U.S. The participating companies would agree to have in place a supply chain protocol validated by U.S. Customs-Trade Partnership Against Terrorism; a plan in place to quickly address potential problems; effective recall plans in place and maintenance of control over the drugs from time of manufacture through entry into the U.S. Participants are permitted to have up to five drugs receive expedited priority import entry review. You can see the thirteen companies that have been “pre-qualified” to participate in the FDA press release and there is a Web page on the FDA site devoted to the topic.
- Another Orphan Product Approval – This week FDA approved Chelsea Therapeutics’ Northera for the treatment of neurogenic orthostatic hypertension which is a rare, chronic and debilitating condition often affecting people with Parkinson’s Disease. People with the condition face a sudden drop in blood pressure upon standing. The product was approved with a boxed warning and under FDA’s accelerated approval process.
- FDA Looking to Overhaul OTC Monograph System – FDA announced this week that it would be holding a public hearing on March 25-26 at the agency’s White Oak campus with an eye toward modernizing the process and regulatory framework for OTC Drug Review under the Monograph Process to make it more responsive. The purpose of the hearing is to solicit opinions about how to better position the system in today’s environment. The OTC Monograph system currently provides for the ability to categorically set standards for OTC products so that they do not have to get approval under the new drug approval process individually. However this process put into place four decades ago is somewhat cumbersome. FDA cites particular challenges including the fact that there are a large number of products marketed for which there is not a final monograph available. FDA has set up a meeting information site on the Web site. This will likely be the most important meeting regarding OTC drugs in many years.
That’s it for me this week. The weekend feels like it was a long time in coming. I plan to greet it with open arms. Enjoy.