Well, I am really tardy with this posting – the Weekly Roundup is not only late, it is real late. Sorry, it was not Valentine’s Day festivities, nor was it a result of the snow storms – some of which left my herd grazing on snow. It was just really busy and I was a bit stretched. And I didn’t think in the end, anyone would truly mind.
But there were a few things of note, particularly this first item, so here it is, better late than never:
- FDA Seeking Public Comment on DTC – The agency announced this week in the Federal Register that it would be seeking public comment on its research related to “Disclosure Regarding Additional Risks in DTC Prescription Drug Television Ads”. The comment is on the collection of information, but in this notice FDA lays out its hypothesis about DTC ads as currently implemented with the “major statement” are too long thereby undermining patient comprehension. In other words by being thorough and complete one is being boring and uncommunicative. The ad warnings may be so long and involved that it does not penetrate with the audience. On the other hand, how to get the information that is important into the ears and minds of patients? How to solve the issue? FDA is going to embark on a study with participants who have been diagnosed with one of three possible medical conditions who will view different versions of ads to assess risk comprehension. Should be interesting. You can see more about the study design in the Federal Register notice.
- First Drug to Receive Rare Pediatric Disease Priority Review Voucher Approved – The agency announced approval of Vimizim to treat a rare congenital enzyme disorder called Morquio A syndrome. The condition is caused by a deficiency in a particular enzyme which can lead to problems with bone development, growth and mobility and is so rare that the press release states that there are only 800 patients diagnosed in the United States. The drug got priority review designation and prior to the approval there were no approved drug treatment options.
- New Approval to Treat CLL – A new treatment for chronic lymphocytic leukemia called Imbruvica was approved under accelerated approval to treat patients who have received at least one previous therapy. In addition to being approved under accelerated approval, the new treatment was orphan-product designation. According to the press release, CLL is a rare disease of the blood and bone marrow that gets increasingly worse over time and causes a gradual increase in white blood cells.
There (finally) is the Weekly Roundup for this week. For those of you having a long weekend due to the holiday, I hope you have a good and restful one.