It has been a week of rain and gloom in our nation’s seat of government. It has been cold, gray and unpleasant. Commutes are nasty. The lack of sunshine is getting serious. But on the bright side, pollen has been washed away, the garden appears happy and baby birds have hatched in one of the hanging baskets of flowers I keep on the front porch. So the glass remains more than half full.
Here is a bit of what happened in FDA-world and a little beyond this week that I thought noteworthy and hope you do too:
- NIH Suspends Operations of its Clinical Center Pharmaceutical Development Section Following FDA Inspection – Big oops. On Thursday this week NIH announced that it had suspended operations of its own Pharmaceutical Development Section (PDS) following an FDA inspection. According to the release, FDA responded to the receipt of a complaint and conducted an inspection in late may and discovered what NIH termed as “serious manufacturing problems and a lack of compliance with standard operating procedures.” NIH Director Francis S. Collins, M.D., Ph.D was quoted as saying that he would be personally overseeing the steps to address the situation. The inspection report is located here and media coverage here.
- Congressman Concerned Over FDA Inspection Letters - And speaking of FDA inspections, Ed Silverman this week reported on the Wall Street Journal Pharmalot site an interesting development. Congressman Tim Murphy has sent a letter to FDA seeking details related to the agency’s policies in posting untitled letters regarding manufacturing problems discovered in the facilities of companies making pharmaceuticals. Specifically, he is looking for insights on the timing of posting such letters along with what does into the decision into how detailed the letters are when posted. The concerns seem to be related not to warning and untitled letters from the Office of Prescription Drug Promotion, but rather those that are results of inspections of facilities. The letter was sent ont he 27th of May – no word as to when FDA will respond or if the response will be posted.
- AdComm Approval for HSDD Drug – There have been past attempts to provide a treatment for women experiencing Hypoactive Sexual Desire Disorder but this week we saw the first to get a recommendation for approval by an FDA Advisory Committee. Sprout Pharmaceuticals announced that the company’s investigational product ADDYI (flibanserin) was recommended for approval in an 18-6 vote on the condition that certain risk management options beyond labeling are put into place. While men have had many pharmaceutical options for the treatment of erectile dysfunction, relief for women has not been as forthcoming. All eyes now go to FDA to see what it will do in response to the recommendation.
That’s it for me this week. Have a great weekend everyone.
- Fact: One of the primary uses of the Internet is to seek health information.
- Fact: By 2015, nearly two-thirds of Americans now have a smart phone;
- Fact: Of those owning a smart phone, 62 percent have used their phone in the past year to look up information related to a specific health condition
- Fact: For a significant number of those Americans who own smart phones (10 percent), it is their sole means of accessing the Internet and 15 percent say that they have limited means to access the Internet beyond their smart phone data plan and those dependent on smart phones for Internet access tend to be young, lower income and non-white (Source: Smartphone Use in 2015 – Pew Internet & American Life Project, April 1, 2015) ;
- Fact: Many health sites, and drug-related Websites are not optimized for mobile;
- Fact: FDA needs to provide solid guidance on how to optimize a site for mobile within regulatory parameters.
FDA is not alone in failing to grasp the scope of change that has occurred in communications in the past 10 years. In 2009 when the agency held its public meeting on the regulation of the Internet and social media related to pharmaceutical products, the smart phone as we know it was nascent. By 2011, 35 percent of Americans owned one and today it is not only fairly ubiquitous, it is the primary means for some to access the Internet and seek health information. There is catching up to do.
One of the many holes left in the guidance documents that were finally forthcoming from the agency as a result of that 2009 meeting is with respect to the optimization of web site for mobile. FDA has steadfastly stood by its 20th century paradigm for 21st century technologies that where a drug name and indication occur there must also be risk information. Use of links to incorporate risk information has been deemed clearly unacceptable since the 2009. What does that mean for pharmaceutical companies that need to mobilize brand name sites for use by mobile Internet users?
To find out what was going I visited 10 different drug sites representing a span of therapeutic categories and manufacturers to see how industry was working this issue and found a variance in approach.
- Of the 10 brand-name web sites, 5 either did not exist as stand alone sites or were not optimized for mobile at all, meaning there was no website that was accessible by smartphone that would available to seekers of such information – clearly not in anyone’s interest;
- 2 of the optimized sites had landing pages that had the name of the drug, but did directly not name the indication. Some had links that went to non-optimized information;
- Some of the landing sites had the indication information with the beginning of risk information, but one had to scroll down to continue reading it or there was an very brief indication followed by safety/risk information, which was continued below, with links to other resources.
One could consider that the tortured guidance document from FDA on Internet/Social Media Sites with Character Space Limitations might be of some help. While widely considered to address Twitter as a platform, FDA did not seek to make its guidance platform specific. There may a structure or insights – one could lay out a sort of mobilized landing page based on the parameters of what must be included in the fictional tweet example that FDA provided, but it is not clear.
In short, the lack of guidance has led to a hodge-podge approach for brand name drug sites to optimized for mobile. Where there is not optimization, users must navigate small test to find brand information on a non-optimized company site or non-optimized brand site which is not an ideal circumstance to say the least. While most can resort to seeking the information on full screen, many will not have access and those who are being disadvantaged would appear to be the young, poor and non-white.
The changes that have occurred in communications have had a profound effect that has been underestimated by many, including FDA, but it is time for the agency to come up with a 21st century approach not only to changes in communications, but in the slow and laborious way that such communications are regulated.
In spite of the fact that summer does not officially begin until the Summer Solstice which will occur on Sunday, June 21, if you are like me and many others the unofficial beginning of summer happens on Memorial Day. And Memorial Day was last weekend and it was early this year. Labor Day on the other hand will be late. That means that it is going to be a much longer summer than we usually get to experience wearing linen, white bucks, Hawaiian shirts. If that is your cup of tea, you are in for a treat.
And speaking of treats, here are a few for you this week.
- FDA Approves New Treatment for LAM – The agency is continuing its long streak of approvals for rare conditions with the announcement that Rapamune was being approved for lymphangioleiomyomatosis – LAM – which is a rare, progressive disease of the lungs that primarily affects women of child bearing age. With LAM, there is apparently an abnormal growth of cells that invade lung tissues that can cause destruction that affects air flow. According to the agency’s release, the condition is extremely rare, though in looking around on the Internet, estimates seem to vary. Per the LAM Foundation, the cause of the condition is not known, but you can learn more about the condition there, including an insightful breakdown into each element of the long name – lymphangioleiomyomatosis. Rapamune was originally approved in 1999 to prevent organ suppression for patients (over 13) receiving kidney transplants and was given breakthrough therapy designation, priority review, and orphan drug status.
- Irritable Bowel Syndrome Patients Have Two New Drugs - Treatment options for patients with IBS have been narrow and the category has been the subject of a great deal of scrutiny by FDA Advisory Committees. This week FDA announced approval of two new treatments from two different companies for those patients who have IBS-D – the type associated with diarrhea. The new treatments are Viberzi (eluxadoline) and Xifaxan (rifaximin) and both are taken orally.
- NIH Funded Study Likely to Result in HIV Treatment Changes Globally – From the time that long-awaited effective treatments for HIV emerged, there existed the accompanying question of when it is best to introduce therapy to an infected individual. A new study – Strategic Timing of AntiRetroviral Treatment (START) – is the first large-scale randomized clinical trial that establishes that earlier antiretroviral treatment benefits all HIV infected individuals. The study found that if individual who are infected begin treatment earlier after infection rather than later, then they are less likely to develop serious illnesses as a consequence of their infection and less likely to develop AIDS. In addition, as noted by Dr. Anthony Fauci, NIAID Director, in the NIH press release, earlier treatment has the double benefit of not only preventing illness, but in reducing the risk of transmission as well. The study will conclude at the end of 2016, but interim results were released early due to their likely impact.
That is all for me this week folks. Have a wonderful weekend – begin to enjoy the summer. Wear straw hats. Go on picnics. Play in the garden. Be well.
Needless to say, every time a product goes before an FDA Advisory Committee (AdComm), there are circumstances that make the deliberations that occur during that meeting a unique experience. A specific investigative compound being studied for a specific indication with its own clinical trial track record for safety and efficacy to consider by a large group of people of varied backgrounds to pass on a recommendation for its use, or not, in a therapeutic are that may be serious or not and where there may already be many existing choices or none. And those are just some of the variables.
I have worked many times over the years to help teams prepare for such meetings and the issues that will likely come up. It has involved everything from helping to message out the presentations that teams make in an advisory committee to speaker prep to researching the panel to preparing for various communications issues facing the compound or the sponsor.
Some of the prep involves looking at the environment very narrowly – examining a few issues close up – and some of the prep may be macro – how has this committee dealt with similar issues in the past? Do some committees present unique patterns? Who meets most often? Who approves more of what they see?
So I have put together yet another database – the FDA AdComm database to look at just a few of those questions and more. I have gone back through 2009 and compiled an overview of the meetings of all of the advisory committees related to drugs since then. While it is a work in progress, I thought I would share some of the preliminary topline numbers.
- How Many AdComms have Occurred? By my count there have been 298 advisory committee meetings since the beginning of 2009;
- How Many were Joint Meetings? Of those 298 meetings, 69 of the meetings have been joint meetings where a meeting occurs with members of another committee, often the Drug Safety Risk Management Committee – only 22 of those meetings have involved consideration of a product approval and of those 22, only 8 (36 percent) have been recommendations for approval;
- How Many Meetings Involved Product Approvals? 170 AdComm meetings have been in regard to product approvals and of those, the product was recommended for approval 111 times – or 65 percent of the time;
- Which Committee Had the Most Meetings? The Committee with the most meetings was the Oncologic Drugs Advisory Committee which met 42 times, only 23 of which were product approval meetings with 56.5 percent of those being recommended for approval;
- Which Committee Had the Most Products Approval Recommendations? The Committee with the most product approval meetings was the Endocrinologic Drugs Advisory Committee which met a total of 33 times, but 27 of which were product approval meetings and 23 (85 percent) of those products were approval recommendations;
- What Committee Met the Fewest Number of Times? The Pharmacologic Drugs Advisory Committee had only 4 meetings, 3 of which regarded product approvals and 2 of which were recommended for approval.
- What Committee Had the Highest Percentage of Approvals? The Dermatologic and Ophthalmologic Drugs Advisory Committee had 5 meetings that involved product considerations and recommended approval for all 5 of them and so got 100 percent.
One final question being compiled – how many times did FDA go against the recommendation of the advisory committee? The answer to that question is still being researched and the data entered.
AdComm prep is very complicated, and I go about it from many angles. But this is one more way – a kind of fun way – to get a big picture and just one more little piece of data to throw on the pile. Besides, I always wanted to do it.