Up Scope! Pharma, Periscope and Some Regulatory Questions

Back in June in a posting about the new (relatively) live streaming capability brought to use by Periscope. The app, acquired by Twitter prior to its launch early in 2015, allows you to live stream content from where you are to your followers who can provide commentary – and to allow your Twitter followers to see it afterwards, including the comments. Periscope, in essence, allows you to be your own reporter. In the June posting, I talked about how it might be used to film AdComm outcomes and that it had great utility in healthcare for developments and announcements at medical meetings.

But would a pharma company use Periscope? Are there special regulatory concerns that might be in play given this particular digital venue? Here are thoughts on each question.

So are pharma companies using Periscope?  You bet.

I checked out this list of the top 25 pharma companies by global sales.  I found that 10 of them – or 40 percent of the top 25 pharma companies – appeared to have established Periscope feeds and some of them are even following the Eye on FDA Periscope feed (thank you!). They ranged in the size of followership from 0 (though for each of these, I became a follower so now they have at least 1 follower) to 717. I have heard of at least one company holding an event using their Periscope feed.

Which brings us to the second question – are there concerns that regulatory might bring up associated with Periscope use?

What if a company were running a broadcast of a patient group at a medical meeting and someone mentioned an off-label use? What if they stated something that was misinformation about the product? What if they mentioned an adverse event?

So what if someone mentioned an off label use or other misinformation during a pharma Periscope session?  Of course, FDA/OPDP does not issue platform specific guidance documents. But in the June 2014 Draft Guidance document (page 5) on correcting misinformation, FDA had this to say about third party content on a company hosted site when they provided an example:

“A firm hosts a discussion forum about its drug or devices’ FDA-approved use on its corporate website and does not participate in the discussion, but it does monitor the forum for profanity and obscenity. The forum includes an overarching and clear and conspicuous statement that the firm did not create the content of the forum. The firm is not responsible for the information that is posted by an independent third party and can, if it so chooses, correct misinformation according to this guidance.”

This might seem to suggest that a third party speaking on Periscope session – analogistic to the corporate website in this case – might convey misinformation and the company would not be responsible – as long as the company were not participating in the interview and was able to communicate a conspicuous statement that the firm was not creating or prompting this content. Or it might not.

Following that example, FDA also states:

“However, a firm’s control over, involvement with, or influence over a product-related communication, even when generated by a third party, may result in the firm being responsible for the information as a promotional communication. Thus, firms might be responsible for UGC that they solicit or influence, regardless of the forum.”

So perhaps if a company asked for an interview with a specific entity, as opposed to benign broadcasting of such an interview by a third party (with a disclaimer), responsibility might ensue.

That is as it pertains to misinformation. Regarding an adverse event – that is one of the five question areas raised in the 2009 public hearing about which we have had no guidance from FDA.  We would only know by further FDA explanation, usually through the issuance of untitled letters, which OPDP has issued only rarely this year. In the meantime, it is up to individual companies to decide how, and if, to proceed.

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Weekly Roundup 11.20.15

The cranberries have been bought and so have the clementines. The cream cheese for the pumpkin cheese cake is in the fridge along with the sausage and green apples for the cornbread stuffing. The turkey is on order for pickup on Tuesday. The menus are planned. My favorite holiday of the year is about to begin!

But it seems that there are others who were getting ready to leave for the holiday and got a lot of stuff out of the door – in other words, there is a lot to report on of interest in the Weekly Roundup.

  • FDA Takes Action on Genetically Engineered Foods – Let’s start with a big one. This week FDA announced several actions related to genetically engineered foods in general and to genetically engineered salmon in particular. Starting with the salmon, FDA declared genetically engineered salmon as safe and set up a part of the FDA site with pages on that topic with a number of documents supporting their position stated in the headline saying that genetically engineered salmon is just as safe as non-genetically engineered salmon. This is the first approval for a genetically engineered animal intended for food. While the safety position of FDA may be true, a number of people might like to know anyway if the salmon they are eating has been genetically engineered. In that regard, the agency further announced via a draft guidance document that such labeling would be voluntary. Finally there was a guidance document on voluntary labeling for foods that been derived from genetically engineered plants.
  • FDA Approves Nasal Spray to Treat Opioid Overdose – With overdose deaths from overdose of opioids on the rise in the U.S., naloxone hydrochloride has played a role in saving lives.  When injected by syringe or auto-injector by a first responder or a family member, it can save a life of a person who has overdosed. With FDA’s approval of a nasal spray formation, an alternative to injection becomes available. The product, Narcan was approved via fast track and priority review.
  • NIH Announces No More Chimp ResearchNIH announced that while recognizing that research involving non-human primates plays an important role in the development of new treatments, NIH followed up on its 2013 announcement to reduce research involving chimpanzees and reduce the NIH colony to 50 by stating that the remaining chimps would be retired. The U.S. Fish and Wildlife Service designated chimpanzees as endangered in June of this year.
  • CDC Report on STDs Released – The New is Not Good – The Centers for Disease Control and Prevention (CDC) released its report on the transmission of sexually transmitted diseases in the U.S. The topline is not good news. There were rises across the board for chlamydia, gonorrhea and syphillis – with chlamydia cases clocking in at a rate of 456 per 100,000 people, a total of 1.4 million. The increases were particularly noted among men.
  • IMS Releases Report on Global Medicine Use – The IMS Institute for Healthcare Informatics released its report on the use of medicine around the world. The report is a global examination of markets in terms of access and spending levels. Using access to medicines as a marker for access to healthcare it is reported that a huge increase in access more medicines around the world and looking as far as 2020 predicts a continued increase for the future.

That’s it for me this week folks. The world has been a harsh place of late, but there is still much to give thanks for. Have a wonderful, warm, safe and thoughtful Thanksgiving. (No Weekly Roundup next week.)

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HIV Celebrity Diagnosis – What’s Changed. What Hasn’t.

On Monday news came out saying that actor Charlie Sheen would be announcing that he had HIV during a TODAY Show interview that would occur on Tuesday. In addition he issued an open letter about his announcement and HIV status.

Thirty years ago I was the Director of Legal Services at the Gay Men’s Health Crisis (GMHC) in New York at the time that Rock Hudson revealed that he was suffering from AIDS.  I was one of the spokespersons for GMHC during the flood of media that resulted with the revelation – interviews that stretched for weeks.

Sixteen years later in 1991 while I was living in Los Angeles, my friend, actor Brad Davis died of AIDS. His diagnosis was revealed with his death, as was my role in his care.  Once again I was doing media interviews, only this time with a personal side to it as well.

A few months later in November, I received a call from a network news producer saying that someone big was coming out with HIV and asking if I knew who it was. I said I did not and in fact, I did not, though I do not think he believed me. A few hours later he called back to say that Magic Johnson was holding a press conference.  In the wake of that one, there were so many subsequent interviews in my role as spokesperson for AIDS Project Los Angeles, I lost my voice.

Since Mr. Sheen’s revelation, I have been struck by a few things – really in how different this was from the others.  Then – Rock Hudson’s diagnosis and death, Brad’s death and Magic Johnson’s announcement all occurred before there were any truly effective treatments for HIV. A diagnosis was widely regarded as terminal. Now -Today, there are at least 7 classes of drugs to treat HIV and 11 combination drugs and the mortality rate has plummeted from the early days of the epidemic.

Then the announcements involved extremely heavy coverage, nationally for the Hudson and Johnson announcement and extensive for the Davis announcement in Los Angeles and in industry publications and the stories were extended for time and in direction – covering multiple angles. Now there was a good deal of media coverage, but the volume and prominence was not what it was in the 1980s and 1990s.

Then – when Rock Hudson was diagnosed, most people did not know a person with AIDS or HIV but his news brought AIDS from the confines of New York, Los Angeles and San Francisco into everyone’s living room. And Magic Johnson expanded that acquaintance even further. Now – people’s familiarity with AIDS and HIV has grown significantly.

But one thing about then – Rock Hudson felt compelled to hide his diagnosis – Brad Davis feared that he would not be able to work again if his were known and asked me to help him get medical care that could keep his secret – then the stigma of HIV was very apparent. But in the story Mr. Sheen revealed to us this week, he stated that he had been blackmailed and extorted since he discovered his HIV status. That tells us one important thing about then and now – something that is not different. Stigma apparently still has great power over a person with HIV – a power that can be crushing. There are over 1,000,000 people with HIV in our country. They have a lot to face. The folks with HIV who came before them have paid a heavy price – and there has been much progress. Stigma should be one aspect of that progress – it should be a bad memory of the early days of the epidemic. It has no place in it today. This should read then there was stigma, now there is not.

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Weekly Roundup 11.13.15

The leaves are falling in earnest and faster than they can be raked and packaged for pickup. The stomach craves comfort food. Thanksgiving goodies are just around the corner. This week FDA had a federal holiday (Veteran’s Day) while many of us did not.

In fact, it was another busy week for me, sadly resulting in no intervening postings here. I will endeavor to post at least one additional next week.

In the meantime, here are a few of the things that did manage to happen:

  • FDA Commish Hearing Scheduled – The Senate HELP Committee has scheduled a hearing regarding President Obama’s nominee for the new Commissioner of FDA, Dr. Robert Califf, currently Deputy Commissioner for Medical Products and Tobacco. Prior to joining FDA in February of this year, Dr. Califf was a professor of medicine and vice chancellor for clinical and translational research at Duke University. The hearing is scheduled for Tuesday, November 17, 2015 at 10 AM. The Committee has set up a page for a live video feed for the hearing here.
  • What Does Natural Mean? FDA is seeking your opinion – at least when it comes to food labels. The agency opened a docket this week to collect information on the use of the term “natural” when used on the labels of food, including food that has either itself been genetically engineered or contains components that have. FDA said that it was doing so in response to 3 citizen petitions asking that the term be defined, one of which sought the prohibition of use of the term on labels. In addition, the agency has been asked by some courts in relation to litigation for information related to the standards for the use of the term. The docket is opened here at Regulations.gov.
  • FDA Letters Regarding DTC Genetic Test Marketing – As our age transitions to one where more consumers are more actively involved in their own healthcare, FDA has once again acted on the matter of genetic tests that are marketed directly to consumers. This week the agency sent three untitled letters – as opposed to warning letters (and note, these are not letters from the Office of Prescription Drug Promotion – OPDP) to manufacturers and marketers of genetic tests meant to inform the consumer whether they have a genetic predisposition to various conditions. This follows other actions the agency has taken with respect to this topic, some going back to 2010. The letters, including a warning letter sent in 2013 to another manufacturer, can be found here.

That’s all for me this week folks. Have a wonderful weekend. Get those leaves cleaned up and start making the menu for Thanksgiving Dinner.

Photo Credit:  Cows in Italy – Anne Becker (with thanks!)

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Weekly Roundup 11.6.15

Every year I am concerned that I will run out of Halloween candy. I never do. Every year there is some left over. Apparently this is my trick and my treat.

We have had an unusual warm spell in the East, making it a balmy opening to November, but nevertheless I find myself craving comfort foods – chili, soups, stews. (Feel free to visit my food blog – www.settingforone.com and don’t worry, the postings are infrequent – it is a hobby.)

It was a relatively quiet week at FDA and OPDP continues to appear dormant when it comes to enforcement. So far this year there are still only nine Warning or Untitled letters issued for the entire year, making this year to be the lowest level of enforcement seen since I’ve been keeping tabs (since 1997 when there were 139 letters issued). And when enforcement has occurred, it has involved relatively small companies – a trend seen over the past few years.

In the meantime, here are a few things that did happen:

  • Guidance Document on HIV Drugs – FDA announced availability this week a guidance document on the development of HIV drugs and is accepting comment related to the guidance. The guidance pertains both to drug and biologic treatments and is for all phases of development, including non-clinical development, early phases, phase 3 protocol designs and endpoints. The guidance also pertains to the range of need – from new drugs to treat to drugs needed to treat those who have viral infection where there is the development of resistance to treatment. The guidance is making final the draft guidance on the same topic and has been revised to reflect comments collected. Additional comment can be submitted at regulations.gov.
  • And Speaking of HIV, A New Treatment Approval – A new combination treatment for HIV was approved this week. Gilead’s Genvoya, a combo fixed dose tablet comprised of elvitegravir, combicistat, emtricitabine, and tenofovir alafenamide as a complete regimen for HIV 1 treatment in adults and pediatric patients 12 years of age and older. The tenofovir in Genvoya is a new form that had not been previously approved and provides lower levels of drug in the blood stream while higher levels within the cells where HIV-1 replicates.  The FDA release also notes that Genvoya appears to have less kidney toxicity and decreases in bone density than previously approved tenofovir regimens and patients also appear to experience greater increases in total cholesterol. Genvoya will carry a boxed warning. The company’s press release can be found here.
  • FDA Approves New Treatment for Severe Asthma – FDA gave the thumbs up to Nucala for the treatment of severe asthma in patients 12 years and older with a history of severe attacks in spite of treatment. Nucala is a humanized interleukin-5 antagonist monoclonal antibody produced by recombinant DNA technology in Chinese hamster ovary cells. The treatment is administered once every four weeks by subcutaneous injection into the upper arm, thigh or abdomen. The press release from the company can be found here.

That’s it for me this week. The last of the peanut butter cups (now frozen) will disappear over the weekend, you can bet. Have a good one folks.

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