Weekly Roundup 7.17.15

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 While Iressa had been approved for a separate use in 2003 and then withdrawn, this use is distinct from its prior designation and was approved as an orphan product.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.

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Weekly Roundup 7.10.15

Here in the mid-Atlantic, we are experiencing daily rains. Not just rains. Biblical deluges. The gardens are happy. The dogs are not.

Meanwhile, while FDA seems rather slow, there is news – breaking news even – and here is a bit of that and other stuff that has transpired:

  • House Passes 21st Century Cures Act – Today the House of Representatives overwhelmingly passed H.R.6 – popularly known as the 21st Century Cures Act. (Vote= 344-77) It is perhaps surprising in that there was bipartisan support and the bill actually aims to accomplish a lot – touching virtually every healthcare stakeholder imaginable from researcher right to the patient. To that end, I wrote a posting for another blog regarding the communications challenges related thereto – and you can catch that here. And in yesterday’s posting on EyeonFDA, I talked about the social media aspects. Passing the House is certainly one hurdle and this bill developed a great deal of momentum, but how will it fare in the Senate?
  • FDA Approves New Drug for Heart Failure – Entresto(TM), a tablet to treat heart failure, was approved this week by the agency which said in its release that it had demonstrated ability to reduce the rate of cardiovascular death and hospitalization. The drug joins many others this year reviewed under priority review and given fast track designation. In the release from the manufacturer – Novartis – it was noted that this was the first and only treatment to show a significant mortality benefit in head-to-head testing against an ACE-inhibitor. You can also check out the digital multimedia press release here.
  • Calorie Count on Menus Delayed – While many menus already provide caloric information, the agency announced this week that it would be extending the date for compliance with the Final Rule which was published on December 1, 2014. In response to many requests for an extension and even legislation to do so, the agency announced that there would be a one-year delay.
  • FDA Ups the Warning on NSAID Labels – FDA issued a Consumer Update related to the label for both prescription and OTC NSAID products, not including aspirin. The agency is taking action to strengthen the warning related to heart attack and stroke risk. While the labels already contain information related to the risk, FDA is going to require manufacturers to update with more specific information.

That’s it for me this week. I am hoping for a nice, rain-free weekend and hoping the same for you.

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A “Long Shot” at Getting FDA Off the Dime on Social Media

Last month, Politico reported on the communications aspects of the 21st Century Cures Act (the Act) – also known as H.R. 6 – the sweeping legislation that addresses a range of issues related to medical research and access to medicines.  The expansive subject matter of the proposed bill includes funding for new kinds of research, the establishment of new methodologies for clinical trials, creation of new pathways for devices, and providing clarity on expanded access. to name a few.  If you want to catch up on the full range of contents, you can find a two page summary here, a more in-depth section by section summary here; and a set of FAQs here, all provided by the House Committee on Energy and Commerce.

For those who have not been following the evolution of the bill, a prior version had thankfully included specific direction for FDA to issue clear guidance with respect to the use of the Internet and social media by industry, recognizing the heavy patient use – and even FDA’s use – of social media and its role in healthcare communications today. The bill has momentum in the House having unanimously been voted on in Committee and may face a vote this week. Unfortunately, the language related to specific FDA guidance in this regard was dropped from the current version. The bill still references guidance from FDA on facilitating responsible communication, but is silent with regard to the specific topic of digital media.

Once the language was dropped. Rep. Billy Long (R-MO) introduced stand-alone legislation – H.R. 2479 - that would again address the need for FDA to issue guidance related to the use of digital media. In a release from Rep. Long he stated:

“My bill will lead to enhanced, effective and accurate communication between drug manufacturers, doctors and patients. It is now the norm to go online, whether on social media or other online platforms, and find needed information on just about anything… This bill would simply push FDA to update its regulatory approach to communications to keep up with today’s technology… My bill will allow the companies, which know their products best, to state introductory information with a link to more details, just like the FDA does.”

The Congressman deserves credit, trying to address through legislative means what has been realized by many through several years of waiting for meaningful guidance from FDA after its 2009 meeting – that the guidance given falls considerably short of what is needed.

Legislation that would prod the agency into action on this front would be welcome. But while it addresses the symptom, it does not address the underlying problem – the process for producing guidance of any kind. Right now, insight into how the agency regulates communications comes from two sources – guidance documents or warning letters. Neither are good methods for enunciating regulation. FDA needs not only to be directed into producing meaningful guidance related to digital and social media and medicine, but also in  employing a methodology to produce guidance – one that abandons the current methods that are  time-consuming and lacking in transparency. While that perhaps is too much to hope for and in the meantime Rep. Long’s shot at providing greater clarity related to digital social media guidance reform is something to keep our eye on.

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FDA Enforcement of Digital Communications – An Update

In 2013, I published a white paper called “FDA Communications Oversight in a Digital Era” that drew upon the data base I had put together of OPDP Warning and Untitled Letters (referred to collectively as “regulatory action letters”). The object of the exercise was to (1) examine whether or not there had been an increase in regulatory action letters aimed at digital communications platforms given the enormous increase in the use of the Internet for health seeking behaviors by consumers/patients and the use of digital and social media platforms by pharmaceutical and biotech companies, and (2) to assess if there was a different in the patterns of enforcement versus more traditional means of communications.

The analysis of letters that (1) the letters aimed at digital/social platforms were lower in proportion to traditional communications (56 percent of the letters aimed at traditional, 44 percent at digital). And (2) when you looked at the more serious type of letter – Warning Letters – nearly 3 out of 4 (73 percent) involved traditional communications vehicles and only one-fourth were among social/digital. Finally (3), the rate per year did not show an increase year over year in the proportion of letters aimed at digital/social.

The analysis looked at letters from the years 2008-2012 to capture the ascendency of social media. I thought enough time had passed to do a little update to see if there had been any change in the patters since 2012.

Since then there have only been a total of 38 letters issued 2013-today, inclusive. Those letters represented 40 different communications vehicles. Of the 38 letters, only 14 involved a digital/social communications vehicle.

So, even though the output from OPDP has been extremely low, from what little experience there is with the issuance of regulatory action letters by the agency there has been no increase in attention to digital media over traditional media since 2012. In fact, if anything, enforcement vis a vis digital media is a diminished focus.

What does it mean? That the EyeonFDA Warning Letter database cannot tell us. Does it mean that digital media is safer than traditional? Probably not. Does it mean that more communications occurs in traditional than in digital? We don’t know, but what I do know from a separate data base that tracks social media activity among pharmaceutical companies, as well as the information supplied on patient use of the Internet in seeking health information and huge number of Websites that exist – it is hard to imagine that digital media around healthcare is dwarfed by traditional. Does it mean that FDA doesn’t care as much about digital and social media as traditional? Again, probably not though some might reasonably think, given the track record on guidance in this area, that it might not be a priority.

Finally, does it mean that industry does not need to exercise as much caution when communicating through digital and social means? Definitely not. In the end, what it may mean is that even as new means of communications come (and go) in digital media (See “Live Streaming – Game Changer at Medical Meetings and Beyond“) FDA is still coming to grips with how to regulate the 21st Century from the 20th.

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Weekly Roundup 6.19.15

No postings this week – sorry about that – travel and business, but will shoot for some good ones next week.

This was another week of tropical rain – the kind that comes and dumps steady water as if a large sponge were being wrung out overhead. The garden is having a mixed experience – the lettuce has had it and so has the dill. The basil, rosemary and thyme on the other hand, appear thrilled. I am less so. In a few days, we will have the longest day of the year. In the meantime, it was an interesting week where the  agency really made some headlines with some news that was both wide and deep and some interesting developments transpired.

  • FDA Moves to Remove Trans Fats – By now, nearly everyone has heard the news that the agency announced this week related to Trans Fats. FDA is giving food manufacturers three years to remove all partially hydrogenated oils (PHOs) – the source of trans fats – from food. This action finalizes a 2013 preliminary determination that PHOs would no longer hold the Generally Regarded as Safe (GRAS) status. You can learn more about GRAS status here. While providing a three year window, FDA is encouraging consumers to check labels to reduce dietary exposure to PHOs. The agency noted in its press release that “currently” food that is labeled as zero transfat may in fact have up to .5 grams per serving. One wonders if the use of the word “currently” signals a change in the future.
  • FDA Partners with PatientsLikeMe – PatientsLikeMe announced this week that the company had entered into a collaborative research agreement with FDA to assess how patient-reported data can have a role in risk assessment and risk management. This new effort appears to open up a new avenue for the reporting of adverse event experiences and pave a new way for the inclusion of patient generated data. In the larger context, patient generated data is occupying a bigger role in medical research – particularly with the addition of wearable devices. There was no word in the release from PatientsLikeMe on the details of the effort.
  • FDA Takes Action on Illegal Website Sales – This week the agency announced that it was participating in the eighth sweep of action against websites globally that are selling unapproved or counterfeit drugs and devices to consumers. According to the release, action was taken against a total of 1050 websites. Called “Operation Pangea VIII”, FDA said it sent Warning Letters to operators of nearly 400 websites and in collaboration with other federal agencies did screenings and seizures of material through International Mail Facilities in various cities in the U.S. FDA also provides in the release resources to help consumers identify whether or not a source is possibly an illegal pharmacy.

That’s it for me this week folks. Have a good weekend and enjoy the longest day of the year. Happy Summer!

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