It was a wickedly busy week so apologies for the paucity of postings. We are over the half-way mark for the year – if the year were represented by the days of the week, it would be Wednesday. Summer school has started. The mosquito has returned. Fireflies flash hello at dusk. Lucky people are at the beach. Me – not so lucky.
Here is a bit of what transpired on this hump day of the year.
- FDA Approves New Type of Leg Prosthesis - This week the agency announced that it has approved a new prosthesis leg device manufactured in Sweden. Current prosthesis involves the use of a cup-like socket that fits over the residual leg of the patient, however for various reasons, some patients are not able to utilize the socket. The new device Osseoanchored Prosthesis for the Rehabilitation of Amputees (OPRA) is surgically implanted through two procedures using screws and fixtures to the thigh bone. There is a post-surgical course of physical therapy that lasts several months.
- Approval for NSCLC First Line Therapy - This week FDA gave a thumbs up for use of Iressa (giftinib), a kinase inhibitor, to be used as a first-line therapy for patients with Non-Small Cell Lung Cancer where tumors have specific types of epidermal growth factor receptor (EGFR) gene mutations. The therapy targets the most common type of EGFR mutations and FDA referred to it as an example of a highly targeted therapy for treating lung cancer. While Iressa had been approved for a separate use in 2003 and then withdrawn, this use is distinct from its prior designation and was approved as an orphan product. The company press release can be found here.
- Drug Approval for Two Indications in Mental Health - Otsuka’s Rexulti (brexpiprazole) was approved by FDA this week for two indications – for the treatment of schizophrenia and as an add-on treatment for patients with major depressive disorder (MDD). The drug will have a Boxed Warning and were evaluated in separate clinical trials. The company press release can be found here.
That’s it for me this week folks.
Here in the mid-Atlantic, we are experiencing daily rains. Not just rains. Biblical deluges. The gardens are happy. The dogs are not.
Meanwhile, while FDA seems rather slow, there is news – breaking news even – and here is a bit of that and other stuff that has transpired:
- House Passes 21st Century Cures Act – Today the House of Representatives overwhelmingly passed H.R.6 – popularly known as the 21st Century Cures Act. (Vote= 344-77) It is perhaps surprising in that there was bipartisan support and the bill actually aims to accomplish a lot – touching virtually every healthcare stakeholder imaginable from researcher right to the patient. To that end, I wrote a posting for another blog regarding the communications challenges related thereto – and you can catch that here. And in yesterday’s posting on EyeonFDA, I talked about the social media aspects. Passing the House is certainly one hurdle and this bill developed a great deal of momentum, but how will it fare in the Senate?
- FDA Approves New Drug for Heart Failure – Entresto(TM), a tablet to treat heart failure, was approved this week by the agency which said in its release that it had demonstrated ability to reduce the rate of cardiovascular death and hospitalization. The drug joins many others this year reviewed under priority review and given fast track designation. In the release from the manufacturer – Novartis – it was noted that this was the first and only treatment to show a significant mortality benefit in head-to-head testing against an ACE-inhibitor. You can also check out the digital multimedia press release here.
- Calorie Count on Menus Delayed – While many menus already provide caloric information, the agency announced this week that it would be extending the date for compliance with the Final Rule which was published on December 1, 2014. In response to many requests for an extension and even legislation to do so, the agency announced that there would be a one-year delay.
- FDA Ups the Warning on NSAID Labels – FDA issued a Consumer Update related to the label for both prescription and OTC NSAID products, not including aspirin. The agency is taking action to strengthen the warning related to heart attack and stroke risk. While the labels already contain information related to the risk, FDA is going to require manufacturers to update with more specific information.
That’s it for me this week. I am hoping for a nice, rain-free weekend and hoping the same for you.
No postings this week – sorry about that – travel and business, but will shoot for some good ones next week.
This was another week of tropical rain – the kind that comes and dumps steady water as if a large sponge were being wrung out overhead. The garden is having a mixed experience – the lettuce has had it and so has the dill. The basil, rosemary and thyme on the other hand, appear thrilled. I am less so. In a few days, we will have the longest day of the year. In the meantime, it was an interesting week where the agency really made some headlines with some news that was both wide and deep and some interesting developments transpired.
- FDA Moves to Remove Trans Fats – By now, nearly everyone has heard the news that the agency announced this week related to Trans Fats. FDA is giving food manufacturers three years to remove all partially hydrogenated oils (PHOs) – the source of trans fats – from food. This action finalizes a 2013 preliminary determination that PHOs would no longer hold the Generally Regarded as Safe (GRAS) status. You can learn more about GRAS status here. While providing a three year window, FDA is encouraging consumers to check labels to reduce dietary exposure to PHOs. The agency noted in its press release that “currently” food that is labeled as zero transfat may in fact have up to .5 grams per serving. One wonders if the use of the word “currently” signals a change in the future.
- FDA Partners with PatientsLikeMe – PatientsLikeMe announced this week that the company had entered into a collaborative research agreement with FDA to assess how patient-reported data can have a role in risk assessment and risk management. This new effort appears to open up a new avenue for the reporting of adverse event experiences and pave a new way for the inclusion of patient generated data. In the larger context, patient generated data is occupying a bigger role in medical research – particularly with the addition of wearable devices. There was no word in the release from PatientsLikeMe on the details of the effort.
- FDA Takes Action on Illegal Website Sales – This week the agency announced that it was participating in the eighth sweep of action against websites globally that are selling unapproved or counterfeit drugs and devices to consumers. According to the release, action was taken against a total of 1050 websites. Called “Operation Pangea VIII”, FDA said it sent Warning Letters to operators of nearly 400 websites and in collaboration with other federal agencies did screenings and seizures of material through International Mail Facilities in various cities in the U.S. FDA also provides in the release resources to help consumers identify whether or not a source is possibly an illegal pharmacy.
That’s it for me this week folks. Have a good weekend and enjoy the longest day of the year. Happy Summer!