Weekly Roundup 10.9.15

The days are growing noticeably shorter. The autumn chill has made itself felt from time to time. The leaves look ready to do their turn. The garden is in want of a mulching. Pumpkins are expectantly perched on front porches awaiting the arrival of Trick or Treaters. There is of course Halloween candy to be bought. Linens have disappeared and sweaters have come out of hibernation. Autumn is here.

And also here are a few things that happened this week that I thought notable for the Roundup!

  • New Injectable Approved for Schizophrenia - FDA announced this week the approval of Aristada™ (aripiprazole lauroxil), an extended release injection to treat adults with schizophrenia, administered by a health care professional every four to six weeks. As with other antipsychotic medications used to treat this condition, the product will have a Boxed Warning related to off label use in older patients with dementia-related psychosis and it will be accompanied by a Medication Guide. In August, FDA notified the manufacturer that it would not be meeting the PDUFA date that had been set. According to the manufacturer’s release, the product contains a range of dosing options and intervals to meet individual treatment needs.
  • New Tobacco Campaign from FDA – One does not often think of associated the term “FDA” with the term “hip-hop” but that is what is happening here. The agency announced this week that it was launching a new campaign aimed at preventing and reducing tobacco use among multicultural youth. The reason? Research has shown that these are the folks are more likely to use tobacco than other groups within this age bracket. The agency concedes that this is a hard-to-reach audience that has frequent exposure to pro-tobacco use messaging. Termed the “Fresh Empire” campaign, it relies on ads and paid media, but also on outreach. The campaign launches October 12 and examples of ads are contained in the press release.
  • More AIDS News from WHO and a Campaign Aimed at Improving Adolescent Health – Last week WHO announced a proposed change in treatment guidelines to expand treatment to people with HIV and people at risk for HIV both as a treatment and a preventive – mentioned here last week in The Weekly Roundup. In the U.S. and perhaps other nations in the West, we have seen the urgency of HIV subside with the rise in treatment. However, WHO reminded us this week when it launched new global standards to improve healthcare for adolescents throughout the world that HIV/AIDS is still a pressing issue demanding both medical and humanitarian attention with AIDS being the leading cause of death among adolescents in Africa and the second leading cause of death globally.
  • Ed is Back! Pharmalot, Pharmalittle – a virtual cup of coffee with Ed Silverman, author and tweeter of Pharmalot is back. Ed returned Pharmalot to activity this week here as he transitions the blog. He said that “Pharmalot will continue its coverage as part of the new Stat site devoted to health, medicine and life sciences that is being launched by The Boston Globe.” Welcome back Ed!

That’s it for me this week folks. Have a great weekend and don’t forget to buy the candy so that you are not rushing out at the last minute.

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FDA Needs a Communications AdComm

When it comes to communications, the environment has been fast, the FDA – slow.

A few months ago I talked about a few of the potentially game changing implications of some relatively new platforms – Meerkat and Periscope, which allow for a person to live stream video and to reach large audiences doing so.

The emergence of live-streaming characterizes the times in which we live, from a communications perspective. New platforms come onto the scene – many disappear, though that doesn’t mean that they don’t present some serious strategic challenges, particularly from a regulatory/legal point of view (remember Sidewiki?).

FDA took into account the rapid velocity of change when it considered its approach to providing regulatory guidance (albeit limited) given the emergence of digital media in that the agency did not seek to address platform-specific circumstances.

Rather, FDA sought to enunciate principles for operating within the digital environment that could be applied across media. So the guidance regarding use of platforms with character space limitations is called exactly that – and not the “Guidance on Twitter”. That guidance, in particular, addresses what not only what is obviously Twitter but also talks about creating ads where there is limited space.

However in reading it, one would be hard pressed to entirely understand FDA’s thinking with regard to optimizing a web site for mobile. (See “Regulatory Considerations in Optimizing a Site for Mobile” – June 3, 2015) Not having such guidance is more than an inconvenience, mobile access is the primary means for accessing the internet for many people who are seeking health information.

While the agency considered changing platforms when devising the actual guidance itself, FDA did not take into account the rapid shifts when it considered its process for providing guidance.

What little guidance has been provided has never addressed the full scope of questions raised in the public meeting of November 2009 and in the end has probably not changed the status quo much.  Manufacturers were concerned about a branded approach to Twitter before the guidance documents were issued and continue to be afterwards. There was a risk associated with correcting misinformation before the guidance on that topic and there is risk associated with it after.

As stated here many times, when it comes to digital media, the world has had to move on without FDA in many respects. The agency has developed its own assets, but has been mum about how it will proceed with regulation in this area and when – a silence that does not serve any visible good purpose.

It is way past time for FDA to take a more engaged approach and develop a Communications Advisory Committee to support its thinking in this space. Such a committee could meet four times a year to consider changes to the social media scene, such as Meerkat and Periscope, as well as unfinished business – such as providing guidance on how companies should go about optimizing their websites for mobile. A communications advisory committee would also add something that has been lacking up until now to the process – transparency. And it would allow for the agency to consider changes in platforms, strategic questions and get input from both industry and patients on an on-going basis. In short, it would be a vast improvement over the existing system of the sporadic issuance of incomplete guidance documents, an opaque process, and the lack of regulatory enforcement to help define the environment.

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Communications + Medicine = Public Health – The WHO HIV Guidelines and the Role of Comms

Last August I wrote a posting about the important role of communications during the initial stages of an emerging contagious or communicable disease. But communications not only serves a vital purpose at the beginning of an epidemic, it also does so when you are trying to end one.

As mentioned in the Weekly Roundup last week, the World Health Organization (WHO) has announced a new guideline document related to HIV treatment. By expanding access to antiretroviral treatment (ART) both for people with HIV and for people at high risk for HIV by offering pre-exposure prophylaxis (PrEP), WHO is aiming to avert more than 21,000,000 deaths and avoid 28 million new infections by 2030, effectively altering the face of this epidemic as we have known it. The aim is breathtaking. But the road for getting there is not going to be as simple as handing out pills.

A great deal needs to accompany medication. First of all, it requires policy support for expanding access and to commit to it once it is expanded. The costs associated with a lack of such commitment are evident when looking back to the world’s experience with tuberculosis and the emergence of multi-drug resistant TB. Once commitment falters, risk rises. That is perhaps the first role here for communications – one of effective advocacy for both expansion and long-term commitment.

The other is in education. The call for expanded access is premised on the results seen in clinical trials where the use of treatment as prevention was successful. But in real world circumstances, patient education and on-going support is going to be essential to success. WHO recognizes this, saying in the release that “countries will need to ensure that testing and treatment for HIV infection are readily available and that those undergoing treatment are supported to adhere to recommended regimens and are retained in care.” But it is a point that merits emphasis.

As someone who began his career in the earliest and frightening days of this awful epidemic, the turning of this page is almost difficult to believe. Those early years when there was no treatment – and not even a test – meant you did not know if you were infected. Your only knowledge of your health status came with a diagnosis that meant your immune system was gone. We have come so far in the nearly thirty-five years it has lasted. Progress has been built on good advocacy, good science, good policy and good communications – all of which made happen by the unique application of all the stakeholders. There is a role and a responsibility for each and every stakeholder in seeing this through.

World AIDS Day will take place this December 1. The prospect of the new WHO guideline offers an opportunity to use that day for a really substantive discussion on how the guideline gets supported and maintained by each and every stakeholder involved. It is now about more than a red ribbon to express sentiment. Let’s end this epidemic.

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Weekly Roundup 10.2.15

Joaquin is a knock knock knockin’ at our door. While the government did not shut down due to a political crisis, it may not be clear that a weather crisis won’t do the job. Washington can always use a good airing out, but a hurricane is actually not the preferred method. I hope it is dry and warm wherever you are.

My travel schedule this past week kept postings at a minimum, but here is the Weekly Roundup with a bit of what happened this week and a little bit from last, that was of interest:

  • Two New Diabetes Treatments Approved - Last Friday FDA announced the approval of two new diabetes medications – Tresiba (insulin degludec injection) and Ryzodeg 70/30 (insulin degludec/insulin aspart injection) to improve blood sugar control in adults with daibetes mellitus. Tresiba is a long-acting insulin and Ryzodeg 70/30, a mixture of a long acting insulin analog with a rapid acting one. The new treatments are manufactured by Novo Nordisk. The company press release with fuller information on Tresiba can be found here.
  • New Laser-Based Hearing Aid - FDA cleared for marketing a new hearing aid that uses a laser diode and direct vibration of the eardrum to amplify sound for people with hearing impairment. The device has two parts – a tympanic membrane transducer (TMT) which is placed into the ear canal on the eardrum through non-surgical means and a behind the ear (BTE) audio processor that sits on the outer ear but is connected to an ear tip that is placed in the ear canal. The release describes how the device works as follows – external sound waves received by the BTE processor are converted to electronic signals, digitally processed, amplified and sent to the ear tip, which contains a laser diode and are then converted to pulses of light. These then shine onto a photodetector in the TMT, converting it back into electronic signals, transmitting sound vibrations directly to the eardrum by direct contact. If that sounds a bit much, you can see more on the company website.
  • WHO Announces Change to HIV Recommendations - As someone whose career began in the earliest days of the HIV/AIDS epidemic when there were no effective treatments, it was absolutely breathtaking yesterday to see that the World Health Organization had issued a call for the wide scale treatment of all people with HIV and to offer treatment as a preventive measure for people at high risk. Because treatment has been shown to act as a preventive, with these new guidelines WHO states that they are seeking to end the epidemic as we know it by 2030. The recommendations mean an expansion of the number of people receiving treatment from 28 million world wide to 37 million.

That’s it for me this week folks. While I didn’t get to posting due to travel, I have some in the can and ready to go next week when we will look at the pain category and regulatory enforcement, among other things. Have a good weekend and if you are on the East Coast, let’s hope the rain and wind is not too bad.

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FDA Adds a New AdComm for Patients

This week FDA published a Federal Register announcement stating that the agency was establishing a new Patient Engagement Advisory Committee designed to provide counsel to the Commissioner on issues related to medical devices. The agency said that the scope is meant to include guidance and policies, clinical trial design and patient preference related to host of issues. FDA also stated that the committee would be put to work identifying new approaches, promoting innovation, recognizing unforeseen risks or barriers, and identifying unintended consequence that could result from FDA policy.

Some specific things FDA says that it is considering asking from this committee include identifying the points, and presumably the process, for patients to provide input during the life cycle of a medical product – from pre-approval to post-approval, and also determining that the priorities and focus should be for such input.

There will be nine voting members of the committee who have backgrounds or expertise in clinical research, primary care and in general of health care needs and trends.  The committee will operate like other advisory committees, with staggered terms and may have non-voting members such as an Industry Representative.

This is the second step FDA has made that institutes some changes in the medical device world Earlier in the month, the agency announced the release of information through OpenFDA. In a September 3 blog posting on FDA Voice the agency stated that they were making already public information on medical device adverse events and recalls more readily available through FDA’s Application Programming Interface to expand access to the data.

The establishment of such a committee will likely be viewed as a good thing by patient advocates.  FDA also published a notice for individuals and organizations potentially interested in serving on the committee.

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