Well, we have gotten through the first month of the year. We had a lot of days with some pretty warm temperatures and it was evident that many of the daffodils had the idea that it might be a good idea to show up a bit early. Then came the two feet of snow, which by the looks of it could linger until August. Just goes to show you, it doesn’t always pay to be early.
In better shape now than I was before, thanks to shoveling. And then more shoveling. And then some more. And here is a bit of what happened even during the many snow days that closed down government operations, among other things.
- Drug Approved for Liposarcoma – FDA announced approval this week of the first drug to show a survival benefit in the treatment of liposarcoma when it cannot be removed either by surgery or has become advanced and in patient who have received prior chemotherapy that contained an anthracycline drug. FDA is quoted in the release as saying that the clinical trial data indicated that the drug, Halaven increase overall survival time by approximately seven months. Liposarcoma is a specific type of soft tissue sarcoma in which cancer cells that develop in the soft tissues of the body such as muscles and tendons among others occur in fat cells almost anywhere in the body. The drug had priority review status and received orphan drug designation. The press release from the sponsor company can be found here.
- First Untitled/Warning Letter of the Year – As noted at year end, enforcement actions as evidenced through the issuance of untitled or warning letters by FDA’s Office of Prescription Drug Promotion (OPDP) declined to a new low last year. This week a new letter was posted representing the first action from that office since August, 2015 and involved a YouTube video. There was a time when any warning or untitled letter aimed at a social media communications vehicle set off all sorts of alarms in the cautious. It tended to validate the notion that digital media was riskier than traditional communications vehicles, which has been shown not to be based in the record. In this case, FDA noted that the video in question portrayed benefits of the treatment, but did not include mention of the risk profile – a circumstance that would have resulted in a letter from FDA regardless of the medium used to convey the message. In short, it wasn’t a social media thing, it was a message thing.
- Sanders Puts HOLD on FDA Commish – Presidential candidate Bernie Sanders announced earlier in the year that he did not intend to vote in favor of the nomination of Robert Califf for Commissioner of the Food and Drug Administration. This week he went one step further and placed a HOLD on the nomination. Other Senators – Markey and Murkowski – have also placed holds on the nomination. The reasons cited for the hold were the nominee’s past ties to the pharmaceutical industry itself and concern over the pricing of pharmaceutical products. While the hold generated some news coverage, none that I saw made mention of the fact that FDA has nothing whatever to do with the pricing of products.
That’s it for me this week. Still digging out somewhat. And that thing I said the week before last about wanting a big snow. I’m over that now. Be well everyone.
Photo Courtesy of Anne Becker
