Perhaps it is a throwback to childhood, but summer always seems to go by faster than other seasons. And this summer is no exception. Sunflowers are blooming, daisies are beaming, lawn mowers are mowing. It seems everywhere you look, summer is well along when in my mind, the buds have just pushed and daffodils were in bloom. July 4th came and went already when it seems like we just had Memorial Day. Before you know it, we will be back to school.
You may still be away from the long Fourth of July weekend or enjoying a shorter work week if you are back. Just prior, a lot happened last week and some this and since there was no Weekly Roundup last week, we are coving two weeks. Here is some of what I found interesting:
- FDA Launches Oncology Center of Excellence – Both public and private institutions are in the process of responding to President Obama’s “Cancer Moonshot” announced in this year’s State of the Union message and headed by Vice President Biden. The gist of the effort is to better coordinate resources focused on cancer treatment and research to effect outcomes more quickly by concentrating efforts across the board. As part of its response this week FDA named Dr. Richard Pazdur as the Acting Head of FDA’s Oncology Center of Excellence (OCE). According to the agency release, Dr. Pazdur will be working to bring closer collaboration across the FDA centers (devices, biologics, drugs) to develop greater coordination and review of new advances. In his blog posting on the topic, Dr. Pazdur also stressed that the effort will also engage outside FDA as well, ensuring that patients have a voice. Many aspects of Dr. Pazdur’s professional experience and personal life went into the choice. While often FDA communications are in FDA-speak, you can read a very nice 2016 New York Times article about him here.
- FDA Chips in to Move the Needle in Precision Medicine - In his 2015 State of the Union message President Obama launched the Precision Medicine Initiative aimed at speeding up the process by which we would be able to deliver therapies for patients that are determined to be the right ones rather than treatment by trial and error. Fundamental to success in that goal is the development of genetic testing. There are many moving parts, but this week FDA added a contribution with the announcement that the agency was issuing two guidance documents to provide a “streamlined approach” for oversight of genetic testing. According to FDA’s release, new sequencing technologies will allow for the examination of millions of DNA variants at a time, rather than taking a more piecemeal approach. NIH urged researchers to adopt the best practices outlined in the draft guidance documents which the release states were developed to enhance test development while maintaining safety. The two draft guidance documents can be found here and here.
- Zika, NIH and the Olympics – A lot is being written, and a lot more is likely to be written, about Zika and the upcoming Olympics in Brazil. This week NIH announced that it was funding a Zika study of the U.S. Olympic team to monitor potential infections among them. The stated goal of the study is to better understand how the virus persists in the human body as well as to identify personal factors that may influence the course of the infection. In another Zika development, FDA announced an Emergency Use Authorization for an In Vitro diagnostic device for use in the detection of Zika virus.
There is more of interest, but that’s it for me this week folks. Next week I will provide you with an update on what FDA had to say during the first half of 2016 and how it compares to other years. Until then, have a good weekend!
We are enjoying more respite from heat here in the mid-Atlantic. Certainly a difficult week that brought reflection and sadness for many. And so we’ll get right down to some of the things that happened FDA-related that were noteworthy:
- Tragedy in Orlando and FDA Blood Policy – In the wake of the Orlando tragedy that so heavily involved the LGBTQ community, most members of the community were barred by FDA policy from donating needed blood to help treat survivors. In a guidance document issued last year, FDA had revised its extreme policy of defacto deferral of all donations from gay men to one that deferred donations from gay men who had had sex within the past year. (See “The Guidance that Dare Not Speak its Name“). Other countries have followed suit. The tragedy drew scrutiny on the latest deferral policy raising question as to whether or not the new construct was in fact justified. From an issues management perspective as well as a policy perspective, FDA would do well to convene another public forum on the matter and cast the net widely for input.
- FDA Approves Cholera Vaccine - This week FDA announced approval of a new vaccine to protect against cholera. Called Vaxchora, it had fast track designation and priority review status and is the first such FDA approved vaccine. While the FDA release states that the vaccine is intended for travelers, in fact cholera can occur in settings where there has been a breakdown in sanitation, such as in the wake of a natural disaster.
- Device to Treat Obesity Approved – A tube that is surgically inserted into the patient that drains a portion of stomach contents after every meal was approved this week by FDA. The approval is meant to provide another device/surgical alternative for patients who do not respond to non-surgical means of weight loss and the release states that it is intended for use in adults with a body mass index between 35 and 55 over the age of 22 years. According to the FDA, the device will allow patients to remove approximately thirty percent of the calories that were consumed during the meal when used 20-30 minutes afterwards.
That’s all for me this week. I had intended to have a posting with an update on pharma and twitter use, but it is now scheduled for next week. Until then, be well and be safe.
We are finally getting some weather that could be described as delightful. I hope that you are too. The grass is green, a breeze blows and there is lots of birdsong in the air. For the first time in years, my little shade garden is not embarrassing.
More importantly, on the FDA front, there were a few official developments and here were a few outside of FDA activities that were of note. Here are a few:
- FDA Sweep on Illegal Internet Sales – Speaking of roundups, there was the annual International Week of Action in the form of Operation Pangea which every year gets a Roman numeral after it and this one was IX. It is the time of year when FDA and other international agencies coordinate to reduce illegal sales of unapproved prescription medications over the Internet. As part of the effort, FDA said in its release that it requested the suspension of over 4400 sites and issued over 50 warning letters. It is perhaps notable that in the release regarding Operation Pangea VIII last year, the agency said that it sent warning letters to operators of over 400 sites, but said that it took action against more than 1000 sites.
- Another Biosimilar AdComm Set – Another AdComm Calls it Quits - An FDA AdComm has been set for July 13 to consider another New Drug Application for a biosimilar, this time where the reference product is Enbrel. A meeting of the Arthritis Drugs Advisory Committee has been scheduled for July 13 to consider several indication for the biosimilar candidate. And in other AdComm news, FDA announced this week that it was terminating (such a choice of words!) the Transmissible Spongiform Encephalopathies AdComm due to lack of issues and corresponding need for advice on the part of FDA.
- Vermont Governor Signs Transparency Pricing Bill into Law – Governor Peter Shumlin of Vermont signed into law this week a first-of-its kind bill that would require greater transparency on the part of manufacturers when raising the price of a prescription medication. The press release from the Governor’s office states that there will be a list of the top 15 price increases each year and that manufacturers will be responsible for justifying those increases to the Attorney General’s office.
That’s it for me this week folks. I hope to have some information for you next week to update you on the use of Twitter by pharma. Until then, have a great weekend.
Weekly Roundups have been in absentia for the past few weeks. Forgive me – it has not been for lack of wanting to get the job done, just time. May began with a serious bout of the flu. While it only had me down a week, there was a lot of catching up, among other things. Even today, the Roundup comes on a Saturday. Moving forward, I will try to be more assiduous.
Given the lapse, I thought I would turn our attention to a few things that happened of note, both this week and in the last few (to cover for some lost time):
- FDA Makes Big Move on Nicotine – You would have to be living under a rock, or have a serious bout of flu, to have missed FDA’s action on tobacco announced early in the month. But just in case you missed the deets, here is a synopsis. First, the agency extended its authority over tobacco to include e-cigarettes, cigars, hookahs and pipe tobacco among others and such products cannot be sold by vending machine nor can samples be given. Second e-cigs will no longer be sold to persons under the age of 18 years. Third, the agency said that newly regulated products will have to be reviewed by FDA and that manufacturers will have to file an application with the agency for consideration so that the agency can review ingredients, health safety and whether or not the product appeals to young people. Products that are already on the market will be given continued market time for a period as time to prepare. In short, the pathway from teen to adult nicotine access narrowed significantly.
- Advances in Detection of Two Different Cancers - June began with the approval of two cancer detection methods for different types of cancers. First as cancer treatments become more and more focused on the type of cancer a patient is facing, the agency announced that a blood test was approved to determine whether or not an important gene mutation exists related to non-small cell lung cancer (NSCLC). The approval means that a treating physician can initially conduct a blood test, as opposed to biopsy, to determine the presence of a particular gene mutation that would be indicative of appropriate treatment. The same day, the agency announced approval of a new diagnostic imaging agent that can be used to detect rare neuroendocrine tumors. The approval had priority status and orphan drug designation.
- Food Labels are Overhauled – In a long-awaited move, the agency announced revisions to the labels that we read when standing in the grocery aisle trying to decide whether to make a purchase (often while others are trying to get by us). While there area many changes coming to the label, to that end, two stand out. First the agency is making changes to highlight the information around the number of calories and the number of servings contained in a product, but more pointedly, the agency is making a concerted effort to point up the sugar content in the product. The date slated for the change for most manufacturers is July 26, 2018.
That’s it for me folks. Hopefully back in the saddle here. Hope you have a good weekend.