Sometimes events present us with a seismic shift in the environment. And often when that happens, we have to have new language to describe the altered terrain. Inevitably there are gaps in our understanding. Familiar frames of reference become obsolete. We keep trying to look at the world through an old lens that no longer is correctly focused.
The health care sector is full of examples of this. For example, when there is an emerging pathogen in play – like the early days of AIDS, or MERS, or SARS or even Ebola moving from a foreign shore to our own – rumor often runs ahead of fact. New terms are introduced but understanding is scant. It is practically a law of nature – where there is a vacuum in information, it is soon filled by the projection of others.
But rapid change is not limited to emerging pathogens. It can be when technology moves ahead at a rapid clip – like social media – leaving many behind (like FDA) and where myths can easily arise (it is only for kids). And it can be about policy change as well. We have only to look at the unfolding of the debate around the Affordable Care Act where “end of life care” and benefits got translated into “death panels”.
There are two areas where some of these seismic type of shifts could occur in healthcare. We would do well now to prepare for the communications challenges later.
The first is with the passage of the 21st Century Cures Act in the House of Representatives this summer – also known as H.R.6. The vote was 344-77, which in and of itself is something of a wow factor. If the Senate moves and this piece of legislation becomes law, it will institute a huge change in healthcare today – from the way that clinical trials are conducted to the way we access care. There is virtually no stakeholder in healthcare who would not be affected by this Act. The fact that there is a gap in time between the overwhelming passage in the House and its resolution in the Senate means two things. First there is going to be some on-going debate and second, the time is now to get caught up on what the bill does and does not do and how it will change not only our care, but our vernacular when it comes to talking about our health care.
The other area chomping at the bit to burst into a wider reality comes with Telemedicine. There have been a number of surveys about acceptance of the notion of Telemedicine and a recent survey publicized in mobilhealthnews found that 41 percent of American consumer had never heard of telemedicine. As public understanding of Telemedicine may be scant, the fact is that the policy and regulatory aspects of it are going to be debated at the federal and state levels. This is a time for many key stakeholders – from providers to medical societies to payers – to get a firm grasp of the implications and develop their communications to help shape consumer understanding as well as policy.
Because communications is the lynch pin to public understanding, or lack thereof, when the environment quickly undergoes change, looking around the corner and preparing early can save a good deal of headache later. Good communications early can save on the effort to undo bad communications later.
It is the end of July! Even though childhood is far away in my rear view mirror, my year is still defined by the school calendar and I find myself lamenting a bit that the summer is already two-thirds over. And the summer has been anything but relaxing – a heavy travel week meant no postings in-between the Weekly Roundup. Hopefully this coming week will provide more opportunity.
While last week was busy at FDA, this week the summer has dialed down the clock.
In the meantime, here is a bit of what happened:
- Non-surgical Device for Obesity – FDA announced approval of a new device to treat adult obesity. It is aptly called the ReShape Dual Balloon System and it works by taking up space in the stomach to lead one to the sensation of being full. The device is inserted through an endoscopic procedure with the patient under mild sedation and the balloon is inflated after insertion with a sterile solution and patients are advised to pursue a diet plan to supplement. The device is indicated for adults with a BMI between 30 and 40 who have an accompanying obesity-related condition such as high blood pressure, high cholesterol or diabetes. The device is manufactured by a company specializing in non-surgical weight loss also called ReShape.
- AdComm Schedule Dries Up – It has been my observation that there are normally a lot of advisory committees on deck that are slated to happen at almost any given time. By my count there have been 19 advisory committee meetings so far this year. But if you look on the current FDA Advisory Committee calendar you will see that there are NO meetings schedule for August and only two in September. Right now, that’s it. It is just THAT slow of a summer.
- Cilantro Import Ban - And speaking of summer – a slightly uncharacteristic note for Eye on FDA – but since we use it a lot in summer (and it is one of my favorites) – it seemed worth noting that the agency this week issued an import alert regarding some cilantro from Mexico. News coverage provides further detail.
- SocialMedia.org Meeting – And in case you are going to be at the member meeting next week of SocialMedia.org being held in Washington on August 4-5, I hope you will come to my presentation. The meeting topic is “How Government Affect Social Media at Big Brands” and I will be joined by the Federal Trade Commission, the National Labor Relations Board, the Securities Exchange Commission, the White House and more. Three guesses what I’m talking about! #fdasm
That’s it for me this week. Have a good weekend everyone.
Greetings from Texas.
Late with the Weekly Roundup here due to some serious travel obligations which are still underway and afford me very little in the way of access to the Internet. Apologies. Had it been a low news-level week, I would have forgone the posting, but it was actually quite active – on Friday FDA issued a whopping 5 press releases in a single day.
And so here it is:
- FDA Approves First in Class Cholesterol Treatment – Twitter was aflutter on Friday with anticipation of the announcement by FDA that the agency was approving Praluent (alirocumab) – an injection approved for use in conjunction with diet and exercise as well as maximally tolerated statin therapy in adult patients with heterozygous familial hypercholesterolemia or patients with clinical athersclerotic cardiovascular disease. The treatment is a biologic – an antibody targeting a specific protein – PCSK9 and works by reducing the number of receptors on the liver that remove LDL cholesterol from the blood. A trial that will look at the impact on cardiovascular risk when combined with statin therapy is ongoing. The release from the sponsors – Sanofi and Regeneron – can be found here. Also earlier in the day came the news that the CHMP had made a favorable recommendation for approval.
- FDA Approves Odomzo for Most Common Skin Cancer - Another important approval came this week with the announcement that the agency was approving Odomzo (sonidegib) to treat patients with locally advanced basel cell carcinoma that has recurred in patients who have had surgery or radiation therapy and are not candidates for repeat treatment. Odomzo works by inhibiting a pathway that is active for basel cell tumors that may stop or discourage growth. According to the company release, Odomzo approval came from a pivotal Phase II trial.
- FDA Approves New Differentiating HIV Antibody Test - The agency announced approval this week of the first test that will allow for the differentiation of antibodies for HIV-1, HIV-2 and HIV-1 p24 antigen in human serum or plasma specimens. The assay may be used to screen organ donors but not for use in screening blood donors except in urgent situations.
- FDA to Hold REMS Public Meeting – FDA is announcing a public meeting entitled “REMS – Understanding and Evaluating Their Impact on the Health Care Delivery System and Patient Access” to be held on October 5 at the FDA White Oak Campus.
That’s it for me this week folks. I hope you had a good weekend.
As regular readers may remember, I have started a database that tracks FDA press releases that goes back through 2014 and provided an overview of the 2014 press releases (See – FDA Press Releases – What They Said and How They Said It) after the year was out. Additionally in the first quarter of 2015, I compared that quarter to the same quarter the year before (see “FDA Press Releases – First Quarter 2015“). Time to take a new look at the first half of the year – comparing the first quarter of this year to the second and then comparing the first half of 2015 to the first half of 2014.
First, let’s look a bit at this past quarter of this year compared to the first quarter of 2015.
- There have been 73 releases during the first half of 2015 but that reflects a considerably slowed down pace in the second quarter - in fact slower by almost half (47 in the first quarter compared to just 26 in the second quarter).
- Of the 73 releases this quarter, a total of 44 were announcing approvals. That was a fast past in the first quarter with 30, but again slowing down considerably with 14 approval announcements in the second quarter.
Looking at this year so far compared to the first half of last year in terms of volume – there were 75 releases in the first half of 2014, compared to 73 in 2015. While during the first quarter there was a robust release of news from FDA making it look like we were headed for a much larger number this year, the second quarter slowdown had an effect.
Looking at the types of releases, the one thing that stands out is that the number and proportion of approval announcements during the first half of 2015 exceeds that of 2014 (64 percent compared to 52 percent). There were also a few more legal actions taken in 2015, though far fewer rules/guidances announced.
It is important to note as far as approvals are concerned, that FDA does not issue a release regarding every single approval – this represents only those approvals accompanied by an announcement by the agency. Also it should be noted that approvals include device as well as pharma and biologic approvals.
Bottom line – The agency got off to a roaring start in 2015, but the pace has slowed down quite a bit.
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.