Weekly Roundup 3.4.15

2016 is speeding by. We are over two-thirds of the way through the first quarter. Mother Nature continues to taunt us. Daffodils were blooming this week, only to have snow accumulating around the blossoms today. Election fever runs rampant as does a never-ending flow of commentary. At FDA, the enforcement page once again displays very little going on - with only a single OPDP letter issued so far this year.

There was actually a lot going on at the agency this week, but in the interest of brevity, here are a few things that caught my eye.  There is a lot about Zika this week and given the outbreak and the approaching summer, that is a trend likely to continue.

  • FDA Testifies on Zika Before House – FDA Chief Scientist Luciana Borio, M.D. appeared before the Subcommittee on Oversight and Investigations, House Energy and Commerce Committee this week to talk Zika, covering key areas of concern and FDA activities related thereto.  A full text of her remarks can be found here. Summarily she covered:
    • Blood and Tissue Safety – She stated that in absence of a blood screening assay, risk of transmission by blood transfusion is considered likely. To that end, FDA has issued new blood donor guidance and this week (see below) issued guidance for human cells and tissue based products. She said FDA is facilitating the development of tests for screening blood;
    • Diagnostic Testing – While there are no commercially available tests now, she stated that the agency has been reaching out to potential manufacturers to encourage and accelerate development and she said that under Emergency Use Authority that FDA had authorized the use of a test for detection of antibodies;
    • Vaccines and Therapies – She stated that there were not any treatments or vaccines in advanced development at this time;
    • Vector Control - She did state that FDA is reviewing information regarding the potential of a genetically engineered mosquito that might help suppress mosquito populations – however if approved an environmental assessment would have to be conducted and released;
    • Fraud – She stated that the agency would be actively monitoring for product claims related to Zika and will implement enforcement actions if necessary.
  • FDA Recos on Zika and Human Tissue/Cells – A few weeks ago FDA issued recommendations related to Zika and the blood supply and this week the agency followed up with Human Tissue and Cell products. In some respects, the recommendations are similar to those for blood – donors should be considered ineligible if they were diagnosed with infection or were in an area with active transmission or had sex with a male with either of those risk factors in the past six months. However, since tissue donation includes that from non-living donors the agency stated that donations should not be considered if the donor had been diagnosed within the past six months – a period chosen with limited data in mind.
  • FDA to Study Cartoon Use in RX DTC Ads – The agency published intent this week in the Federal Register to conduct a study examining the effects of using cartoons in direct-to-consumer advertising of pharmaceutical products to determine if it is a distraction for viewers when it comes to risk information. The agency is seeking public comment on this. As of this writing, no comments had been submitted, but if you are so inclined…. here is a link.

That’s it for me this week folks. Have a good and safe weekend.

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Promotion of Investigational Compound – Historical Overview

Communications regarding medicines in development – often referred to as “investigational compounds” can be particularly challenging. On the one hand, there are data milestones and advancements for the product through the regulatory cycle about which there is great interest. On the other hand, a compound that is being investigated through clinical study for possible approval by FDA should not be promoted nor should it be implied by any means that it has both safety and efficacy for a medical use for which it has not yet been approved. When does the line get crossed?

Specifically FDA regulations state that “A sponsor or investigator, or any person acting on behalf of a sponsor or investigator, shall not represent in a promotional context that an investigational new drug is safe or effective for the purposes for which it is under investigation or otherwise promote the drug. This provision is not intended to restrict the full exchange of scientific information concerning the drug, including dissemination of scientific findings in scientific or lay media. Rather, its intent is to restrict promotional claims of safety or effectiveness of the drug for a use for which it is under investigation and to preclude commercialization of the drug before it is approved for commercial distribution.” (21 CFR 312.7 (a) )

So how often has it happened that FDA has taken action when it perceives that there has been promotion of an unapproved compound and under what circumstances has it occurred?

It turns out that while the omission or minimization of risk information is the most common of all violations that have been cited by FDA over the years, promotion of an investigational compound has not been all that common. Looking back to all of the violations cited by FDA’s Office of Prescription Drug Promotion (OPDP) recently, and back when it was called the Division of Drug Marketing, Advertising, and Communications (DDMAC) through 2004, I have counted only nine letters (out of the total of 309 letters issued during that period) that addressed this particular violation.

Of the nine letters,

  • 5 involved products being investigated for use in oncology
  • A website was the communications vehicle involved in the violation in 7 out of the 9 circumstances
    • The 2 others included one brochure and one involving spoken word where an investigator gave interviews to the media that FDA deemed in violation.
  • All of the letters involved small companies.
  • While the search looked at the years 2004-2016, the first one showed up in 2008.
  • Eight of the nine letters were untitled letters – only 1 was a warning letter.
  • Finally, and perhaps most importantly, a violations cited in these letters are not predicated on a single statement. Rather the letters cite multiple statements made about the efficacy and safety together create an impression that a compound is safe and effective when cited. That is not to imply that an individual statement could not be the subject of a letter, particularly if it were brazen enough, but that the recent letters have looked at more than one statement and the totality of a presentation within the context of the communication.

And here is one interesting note – while letters from OPDP/DDMAC regularly cover more than one violation in a letter, each of the nine involving promotion of an investigational compound shared one characteristic.  They were single issue letters, meaning that the promotion was the sole reason the letter was generated.

If you are interested in seeing each one individually, here are links:

While this posting is not meant to be a tutorial, reading the letters in combination will give one a good idea of the kind of language that runs outside of regulatory parameters in the eye of FDA. Those parameters allow for the exchange of scientific information – so sticking to factual data during pre-approval is important while characterizing outcomes or position of a product in the marketplace takes you away from that.

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Posted in FDA Policy, Regulatory Communications, Warning Letters | 1 Comment

Weekly Roundup 2.19.16

There hasn’t been a Weekly Roundup for the past few weeks, but news has been slow and life has not, so apologies. It seems the shorter days of Winter make it more challenging for me to get all the things done that I need to get done. Once the sun sets, I’m not good for much.

We are in the throes of getting to the wild swings of weather characterizing the latter part of winter. Snow one day, rain the next, followed by fog. Those daffodils that came up early are regretting it.

In the meantime, some of what has transpired:

  • FDA Issues Guidelines on Blood Supply and Zika – As a measure to protect the blood supply from Zika FDA issued guidance this week related to blood collection acting after reports of possible transmission outside the U.S. through transfusion. The agency has taken a two-level approach – one for those in areas where there is not active transmission where the agency is recommending that individuals who are at risk of having been exposed to Zika be deferred from donating blood for a 4 week period. At risk is defined as having had symptoms of infection with the virus, those who have had sexual relations with someone who has traveled to an area where there is active Zika transmission during the past three months, and those who have traveled to locales where there is active transmission within the past four weeks. No mention is made of sexual contact with a person who has been showing symptoms. For areas where there is active transmission, whole blood should only be obtained from areas where there is no active infection. Further information is available in the FDA release on the matter. Undoubtedly, policy will be evolving and expanding.
  • Complete Response Letter Issued for Cardio Combo – In December 2015, an FDA Advisory Committee voted against recommending approval for an expanded indication for the combination of ezetimibe and simivastatin. While currently approved for the treatment of people with elevated LDL cholesterol for those with hyperlipidemia, the expanded indication would have included use for coronary heart disease patients to reduce cardiovascular risk. This week FDA followed the recommendation of the committee and issued a complete response letter.
  • FDA to Offer Docs Course on Biosimilars - The FDA blog – FDAVoice – published a posting this week announcing that the agency would be offering health care providers a free course designed to help in their understanding of biosimilars. The course – FDA Overview of Biosimilar Products – is set to provide information about the development process and approval pathway that FDA is using to regulate the approval of biosimilar products and with the stated goal of helping develop an understanding of the relationships between biosimilars and products that are interchangeable.

That’s it for me this week folks. Have a wonderful weekend.

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This is Your State – This is Your State on Drugs

In years gone by, I have taken occasion to write a posting with this title to take a look at the policy activity that is going on at the state level that impacts medicines. It has been a few years since doing so but it is a good time to revisit the topic. The go-to resource regarding state legislation on a host of topics generally – and on what is happening regarding pharmaceuticals specifically – is the website of the National Conference of State Legislatures (NCSL).

One of the many resources on the site is a data base covering legislative proposals that involve prescription drugs, allowing one to sort legislation based on its category and topic. Through the data base you can also get access to search for the actual text of bills within the various states. Taking a look at what’s going on at the state level is important for a lot of reasons.

  • Biosimilars – While national policy issues often indicate the direction that things are taking – it is often at the state level where details play out. So at the state level right now, a lot of states are looking at the issue of biosimilars. According to NCSL in the past two years 31 states have taken up legislative proposals that deal with the standards of how a biosimilar drug might be used in place of the original brand product. The various characteristics of the state legislation are overviewed here with more details.
  • Prescription Drug Abuse – And the inverse can also be true. While national policy often leaves some of the details to the state level when it comes to implementation, states may take actions that end up driving national policy or that faster than federal policy. A search in the data base across all categories with a key word of “abuse” yields 48 proposed bills across 23 states in 2016. Many of the proposed bills promote access to abuse-deterrent opioid analgesics, such as this bill (Illinois – S 102).
  • Pricing – The database has a category for pricing and payment that contains over 160 bills in over 30 states, but a search of all the categories using the term “pricing” yields a subset of proposals across several states more specifically aimed at the pricing of pharmaceutical products. While a hot topic at the national level, there were only thirteen proposed bills in nine states, with one of the most common proposals being related to setting up a means for studying the issue of pharmaceutical pricing and to make recommendations.

There are also a number of proposals related to the regulation of pharmacy compounding to state legislation on patient “right to try“. The newly expanded and improved resources available at NCSL allow one to find with some precision what one is looking for when it comes to understanding state action in this space.

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10 Years of Eye on FDA – Looking Back

This month marks a decade of Eye on FDA. A good friend of mine was writing a personal blog, which most blogs were back then, that was well-written and funny and I thought – hey I could do that only about professionally-related issues. Well, not as well-written and not as funny as my friend’s blog, Eye on FDA has nonetheless been around to provide insights and commentary on a range of issues related primarily to FDA and the industries it regulates.

Over the years a lot of ground has been covered. Here are a few of my favorite moments looking back:

  • March 2009 – FDA’s First Words on Social Media Regulation - In a posting entitled “A Conversation with FDA/DDMAC About Pharma, Social Media and Web 2.0” a representative from OPDP (then called DDMAC) provided the agency’s first real public commentary on how FDA was thinking of approaching the use of social media by pharma. At the time the agency’s thinking was that it was the message, not the medium and that regulated industry needed to follow guidance that had been given regarding print and broadcast. It was the single most shared and read posting in the entire 10 year history of the blog.
  • January 2010 – Twitter and Congress - Following the 2008 election cycle, the Obama campaign earned a reputation for its savvy use of digital and social media in the campaign. Today, virtually every member of Congress is on Twitter and Facebook and many have blogs, but back in 2009, only about one-fourth of the Congress was there. In “Twongress – the Power of Twitter in Congress” two things happened – the first was coining the term “Twongress” which some people loved and some people hated and the second was the publication of a White Paper that compared the use of twitter between the Republicans and the Democrats in the Senate and the House. The paper got a lot of media attention and then House Minority Leader John Boehner issued a press release about the paper.
  • April 2013 – Is Digital Risker? – The lack of guidance from FDA around social media stretching out for years may have contributed to a perception that social and digital media were risker communications platforms than were traditional forms of communication among those in regulated industry. Who knew?  After working on a database of OPDP/DDMAC warning and untitled letters that spanned back through 2004 – the result was a White Paper – “Some Digital and Social Media Guidance – FDA Regulation of Pharma Communications in a Digital Era“.  One of the fields that was tracked in the data base was whether or not the communications vehicle involved in violations cited in letters were digital or not. A comparison during the years when social media was in its ascendancy (2008-2012) revealed that in fact most violations were still happening on traditional media properties and digital was not growing in proportion nor did it represent a greater proportion of Warning Letters. That is a observation that has held up over time.
  • July 2014 – FDA Issues Some Guidance on Social - Waiting since the public meeting held in November 2009 industry finally saw some guidance in the summer of 2014 with the issuance of guidance documents involving the correction of misinformation and use of platforms where there is character space limitation. “In More than 140 Characters” – an Eye on FDA Webinar to review the regulation of social media and promotion to date. The Webinar had a large number of sign ups, and all in all, the story is still unfolding.

Those are a few of my favorite moments over the course of time. For me, the blog has been a great experience. I pay more attention to what is going on and I think about it more than I probably would have otherwise. I hope it does the same for you. My aim has always been – and will continue to be – the provision of material in the way of news and thoughts that will be helpful to you in what you do. I appreciate all of the readers over the years and all of the Twitter followers at @eyeonfda. Thanks for being here!

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