It has been a busy May.  From working in the yard to transform it from looking like property on which Boo Radley might have a house to putting on panel discussions and layers of business travel to grading papers and posting final grades to end up this semester of teaching.  I didn’t even get time for the Weekly Roundup last week – when lots happened – so I was determined to get it out this week and here it is.  This week there were a spate of interesting approvals – so let’s round it up!  Yee Hah!

But before I do, let me remind you that I will be doing a Webinar on Tuesday, May 21 at 12 Noon Eastern Time where I will be reviewing my data base on FDA Warning and Untitled Letters and comparing enforcement respecting digital versus non-digital communications vehicles.  The Webinar is free and open and I will be going into more detail and discussing additional aspects beyond what was in my White Paper on the same topic from last month – so sign up here.

The Stamp of Approval was busy this week at FDA:

• First Companion Diagnostic to Detect Gene Mutation Associated with a Certain Type of Lung Cancer Approved - FDA announced early this week the approval of the cobas EGFR Mutation test which is a companion diagnostic test to be used in conjunction with an already approved drug.  The test detects epidermal growth factor receptor (EGFR) which exist in approximately 10% of non-small cell lung cancers, the most common type of lung cancer.  This type of diagnostic will provide valuable direction in determining which patients will benefit from which treatment.
• First Nimodipine Oral Solution Approved for Some Brain Hemorrhage Patients – Though approved on May 10, FDA issued a press release on May 14 about the approval of Nymalize oral solution to treat patients who have experienced a ruptured blood vessel in the brain.   Previously this medication had only been available as a liquid filled gel capsule.
• Prostate Cancer Drug Approved – A new drug for those fighting advanced prostate cancer was approved by FDA this week called Xofigo (radium Ra 223 dichloride) three months ahead of the PDUFA date under a priority review.  Xofigo is intended for use in men whose cancer has spread after receiving medical or surgical therapy to lower testosterone.  It is the second prostate cancer treatment approved this year.
• Simponi is Approved for Ulcertative Colitis - FDA approved Simponi (golimumab) injection to treat moderate to severe ulcerative colitis in adults with moderate to severe US that is resistant to prior treatment or which requires continuous steroid therapy.  Simponi works by blocking tumor necrosis factor (TNF).  Simponi is approved for the treatment of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.

That’s it for me this week.  Have a good weekend everyone.  Come to the Webinar on Tuesday!

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The paper is based on a data base that I have compiled that characterizes warning and untitled letters from 2004 onward.  The years 2008-2012 were chosen to reflect a period of time when there was an increasing use of the Internet by people seeking healthcare information and by the ascendancy of social media platforms.

YOU’VE READ THE BOOK!  NOW SEE THE MOVIE!

Well, not quite a movie.  On Tuesday, May 21 at 12 P.M. Easter Time, I will be conducting a Webinar that overviews the findings from the White Paper and will provide some expanded comparisons of digital and social media, as well as a few other observations from the data base.  The Webinar is free and if you would like to register, you can do so here.

The data base allows a vast number of analyses having tracked multiple fields of characteristics including whether a communications vehicle was digital, what type of label the product had (boxed warning or not), the type of violations, the treatment area for the product involved and many more.

I hope you will join me on May 21.

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The grass is not greener on my side, mainly because it is mostly not there.  The lawn, if you want to call it that, looks like it needs a lot of attention – probably more than I have to give it.  Still, that did not stop me from mowing what was there this week for the first time this season as the old mower really did (miraculously) start up for another year.  I am happy to say that many weeds met their end, pulled out by the root after a good, soaking rain….

It was a busy week on many friends, particularly for those of us with our eye on FDA. Here are a few of the things that I wanted to bring to your attention in case it got by you:

• FDA Approves Plan B for Wider Age Range OTC – This was certainly one of the more interesting developments that transpired this week and a lot happened here. First, prior to this week, a court ordered that age restrictions for access to OTC Plan B contraceptive be removed.  Then – this week, FDA announced it was approving Plan B for use by women without a prescription if they were age 15 years or older.  Then, it was reported that the Justice Department announced that it would be appealing that court decision.  This has been a long, long saga. Obviously, it will get longer.
• EMA Opens up Public Comment Period for Guideline on Biosimilars – This week EMA posted their Guideline on Similar Biological Medical Products on line to invite public comment.  The comment period opened May 2 and will run until October 31.
• FDA Approves Procysbi for Rare Genetic Condition – Procysbi (cysteamine bitartrate), marketed by Raptor Pharmaceuticals, was approved this week by FDA for the treatment of nephropathic cystinosis in children and adults.  This is a rare genetic condition that only affects an estimated 500 patients in the U.S. and 3000 worldwide which causes a protein building block (cystine) to build up in every cell of the body which in turn, causes kidney problems and lead to small growth and stature, among other things.
• FDA Investigating Added Caffeine – The agency announced this week that in the face of a growing trend where caffeine is being added to a wider span of food and beverage products there will be a higher level of scrutiny on the part of FDA. Caffeine was approved nearly 60 years ago for use in the manufacturing of cola beverages, but the agency says that existing rules never anticipated the current proliferation of products.  The Q&A supplied by FDA however did not provide much detail into the process the agency will be using to conduct its investigation into existing caffeine in products and what to do about it.

Speaking of caffeine, I think I’m going to take a break here.  I hope you all have a wonderful weekend and are enjoying Spring.

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Since putting together the database of NOV and Warning letters issued by FDA’s Office of Prescription Drug Promotion (OPDP), I have been looking to assess a number of patterns. Sometimes the meaning is obvious, in other’s I am left to speculate.  This is one of the latter.

Every regular reader of Eye on FDA will note that they have frequently seen this chart evolve.  Here is a profile of the combined pattern of Warning Letters and Notice of Violation letters issued by OPDP since 1997 and one will readily observe that the number of such letters experienced a steep decline after the 1990s.  So that is the first point – there are fewer letters than there used to be.

Looking at the same data up close for recent past, here is a more detailed version looking at the period 2004-2012, which is the span of time covered by the Eye on FDA Warning/NOV letter database.

When you break it down between the two types of letters – the more serious Warning Letter (expressed in RED)  versus the NOV letters (expressed in BLUE), you also see that the proportion of Warning Letters has gone down.  So far, for 2013, there are only 4 letters.

So, bottom line, the trend for the number of letters issued has gone down and the trend for the more serious type of letter has also gone down. Cause?  I’m not sure. But would welcome ideas and thoughts from anyone willing to comment.

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The spring clothes are headed to the closet, while the winter clothes are headed to their space for their seasonal slumber until next Fall.  The days are sunny. The winter mess in the yard has been cleared away (mostly) and new grass seed laid down.  Cicadas will shortly be visiting the mid-Atlantic states….

Meanwhile, here is a bit of what happened in our world this week:

• FDA Launches Effort to Protect Against Counterfeit Malaria Meds – This week, FDA announced the launch of a partnership to protect against counterfeit anti-malarial medications involving the use of a handheld detection tool developed by FDA called CD-3.  The public-private partnership is with the Skoll Global Threats Fund, the U.S. Pharmaceopeia, the National Institutes of Health, the Centers for Disease Control and Prevention, the President’s Malaria Initiative, and the U.S. Agency for International Development.  FDA said that the tool can detect falsified product, which can contain reduced amounts of drug that can result in the emergence of resistant strains, thereby posing a public health threat.  The agency is working on improving CD-3 with additional refinements.
• Senate HELP Committee Seeks Input into Draft Compounding Legislation – In the wake of continuing high profile issues related to compounding, the Senate HELP Committee posted draft legislation this week, seeking input into the draft which is due to the Committee by May 3 at 6 PM (ET).  Among other things, the draft legislation establishes a clear boundary between traditional compounders and compounding manufacturers; clarifies that compounded drugs are new drugs subject to FDA jurisdiction; defines FDA’s role in oversight of manufacturers and sets up a user fee type system to fund inspections; and defines roles between states and the federal regulatory authorities.   A link to the draft legislation is included on the newly created Eye on FDA tab that compiles resources related to the developing issues around compounding located on the blog.
• Dr. Hamburg Opens Up FDLI Conference – Cites Budget Situation - Once again, FDA Commissioner Margaret A. Hamburg opened up the FDLI Conference here in Washington this week with an address that provided a comprehensive look at current agency activities and priorities.  She noted that the times are challenging, though the challenges traditionally faced by an agency with such a large mandate is “made all he more difficult as we seek to fulfill our mission with the added pressure of the ‘new austerity’.”  She said that FDA stands to lose approximately 209 million dollars this fiscal year – with $126 million in budget authority and $83 million of that in user fees because although the fees will continue to be collected, they will remain deposited with the U.S. Treasury.  She also provided overviews on the status of implementation of key legislation such as the Family Smoking Prevention and Tobacco Control Act of 2009, the Food Safety Modernization Act and FDASIA as well as discussing aspects of the compounding issue.

That’s it for me this week.  Get those closets switched around everyone.

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But that is nothing compared to the first quarter of 2013, where we saw a total of 3, count ‘em 3, letters issued from OPDP to industry.  Despite the fact that this quarter provides slim pickings, we persevere.

From this quarter, the three letters involved only three communications vehicles, none of which were digital properties (two were brochures) and none of which were Warning Letters and none of which involved drugs with boxed warnings.

The category for most common violation is usually Risk Minimization and while that did get the most this quarter, it tied with Superiority Claims at 3 and 3.  Also included in this quarter was one instance of Overstatement of Efficacy, one Unsubstantiated Claim and one Inadequate Communication of Indication, making a total of 9 violations for the quarter, or 3 per letter.

Will keep you posted on next quarter some time in July.

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It has been a really busy week with travel and work that last Friday I didn’t even get to the Weekly Roundup.  The schedule has been so busy, leaving no spare time for either posting here on the blog or continuing to clear away the dead growth in the garden.  We have had a few minutes of Spring that already seem tempted to ebb into humid muggy days that we should not get till Summer.

But here is a bit of what I saw that happened when I came up for air:

• Compounding the Issues Around Compounding - Three developments transpired this week regarding the increased scrutiny around compounding pharmacies in the wake of an outbreak of meningitis due to sterility issues. Taking them in chronological order – on Monday FDA issued an alert about the lack of sterility regarding products from two compounding pharmacies and serving notice of an impending recall.  Then on Tuesday, the House Energy and Commerce Committee held a hearing entitled “A Continuing Investigation into the Fungal Meningitis Outbreak and Whether it Could Have Been Prevented” that was held nearly simultaneously with the release of a report by the Committee entitled “FDA’s Oversight of NECC and Ameridose:  A History of Missed Opportunities“.  Dr. Hamburg’s written testimony is available on FDA’s Web site, as is her testimony from a previous hearing held by the committee on this topic in November 2012 as well as a hearing before the Senate.  Given the lack of clarity about FDA’s authority with respect to compounding pharmacies, it is probably an issue that is going to continue to be the subject of further public discourse.
• Eye on FDA Tab on Compounding –  Accordingly I have developed a tab on the blog that will be a repository of links to key milestones in the compounding saga.
• FDA Approves Abuse-Deterrent Labeling for Reformulated OxyContin, But No More Generics – The agency announced this week that it had approved updated labeling for reformulated OxyContin which has physical and chemical properties to help reduce abuse potential.  Moreover, the agency said that since original OxyContin now would pose a higher risk, that the agency has recalculated the risk-benefit consideration and determined that the risks no longer outweigh the benefits and therefore will not be accepting any applications to make original OxyContin in generic form.   In addition, FDA provided an updated information page entitled Opioid Medications that outlines agency steps and provides more detailed information about the class.

That’s it for me this week.  I hope everyone has a good and safe weekend.

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Again, the paper was based on a data base I compiled that tracks OPDP letters to pharma companies from the years 2004-2013, inclusive, covering nearly 1000 violations cited by FDA.  For this study, I specifically examined the years 2008-2012 in order to capture the uptake of social media by both mainstream media as well as patients and industry.  For the period, there were 173 letters covering 675 violations.  Each violation was characterized as belonging to a non-digital communications vehicle (brochure, advertisement, spoken word, e.g.) or a digital property (website, banner ad, e.g.).  There were 385 non-digital violations and 290 digital violations.

Here is a look at non-digital vehicles.  You can see that 1 in 3 violations involve either the minimization of risk or the failure to include risk information.  The second highest share of the violations goes to the overstatement of efficacy.

The breakdown shows a very different profile for the digital violations, where the failure to include risk information or minimization of risk had a much larger profile (56%) for digital properties rather than non-digital communications vehicles.  Why?

Remember 2009 when OPDP (then DDMAC) issued 14 letters regarding 45 brands for online ads?  That added a huge number of risk-related violations since the reason those ads were being cited is that the “one-click rule” that everyone thought existed, in fact, did not. That artificially inflated the number of violations related to risk.

When you remove those violations, the two are more similar, though there remains a slightly higher level of risk violations as well as a higher rate of overstatement of efficacy and promotion of an unapproved product. With respect to the unapproved products, these involved 3 oncology products; one involved a Webcast and the rest were Website content.

In the end, the old – it is the message, not the medium, seems to hold true – at least when comparing the types of violations between digital and non-digital properties.

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The daffodils are up and being rounded up in bunches and slipped into vases around the house, spreading good cheer, but overall Spring is still seemingly quite shy though indications are that is about to change.  It is perhaps a good time to give the grill on the BBQ pit a good scraping for the coming season.  It has been a mostly quiet week at FDA – perhaps everyone went away for a Spring Break! As of publication time, there were no press releases from the agency this week, now OPDP warning letters posted…. all quiet.

In the meantime, there were some interesting things:

• Judge Rules Plan B Should Go OTC for All Ages – In a new chapter of a very long story of “morning after” contraception, a federal judge has reversed a reversal of a decision regarding the availability of an over-the-counter application for Plan B.  In 2011, FDA was poised to approve the OTC application but that decision was historically ordered reversed by the intervention of HHS.  Today that reversal was reversed by a federal judge and ordered FDA to approve the OTC application.  Will this close the book on the subject?
• H.R.1150 – Preservation of Antibiotics for Medical Treatment Act - The legislative developments are pretty much appearing here whenever I catch them.  This bill was introduced in the House by Congresswoman Louise Slaughter (D-NY-25) with the purpose of addressing emerging antibiotic resistance as a result of use of medically important antibiotics to a food-producing animal for non-routine disease control.
• FDA Commissioner Hamburg Speaks Out on Painkillers – In a blog posting on the FDA blog FDAVoice entitled “When Pain Relievers Cause Pain, Society Must Act“, Commissioner Margaret Hamburg addressed the abuse of opioids in the U.S.  Stating that in “2010, an estimated 16,651 peopled (sic) died because of inappropriate use of prescription opioid drugs, a 313 percent increase over the past decade”, she outlined FDA’s approach which involved a blend of continuing research about pain, discovery of abuse-deterrent formulations, more accurate labeling, increased education, mandatory training programs for prescribers, new packaging and improving availability of new products that can treat abuse and overdose.  On that same day, Senate Minority Leader Mitch McConnell sent a letter to FDA urging the agency to consider ways to ensure that tamper-resistant efforts taken by brand name pain killers are also in use by generics that come to market.

That’s it for me this week folks.  I hope you all have wonderful weekends and see you next week, when surely Spring will have grown more emboldened.

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I have been working to assemble  a data base of  FDA/OPDP Warning and NOV letters spanning the years 2004-present, tracking activity through a number of fields.  The database now includes hundreds of letters and covers nearly 1000 violations cited by the agency with regard to communications by pharma about medical products.

I tracked several different fields of information.  I can sort by company, time period, product, product indication, type of violation, type of communications vehicle, whether or not the product had a boxed warning, and for our purposes today, whether or not it was a digital communications vehicle (web site, social media e.g.) or a traditional medium (print ad, brochure).

For some time, OPDP – and prior to that DDMAC – has been struggling to understand and respond to the regulatory challenges posed by new emerging digital communications platforms, with little to show for it. Accordingly there are a number of outstanding questions about how OPDP regulates communications on the Internet and digital platforms, including social media.  For some in industry, the lack of guidance has had a chilling effect on participation in social media and even the Internet, despite the fact that it is a resource to which patients regularly turn for information.

As a result, digital and social media have become a sort of regulatory bogeyman.  Lacking any sort of formal guidance from the agency, the only peek into FDA’s point of view is to examine enforcement patterns.  So I have used the data base to compare enforcement patterns vis a vis digital communications. For purposes of this paper, I narrowed the search to the years 2008-2012 (inclusive) to coincide with the ascendency of social and digital media use by pharma.  For this period, I wanted to see how violations by digital communications properties compared to violations by traditional (non-digital) communications vehicles.

In short, I asked the data the following five questions:

1. What was the frequency enforcement among digital versus nondigital communications vehicles used by pharmaceutical companies?
2. What was the comparison of the number of violations involving nondigital communications versus digital communications?
3. Was there a greater frequency of more serious violations for digital versus nondigital communications vehicles?
4. In looking at a year-by-year breakdown, is the rate of violations related to digital communications increasing with the heightened use of digital and social media?
5. What has been the frequency of involvement of social media assets to generate regulatory action letters from OPDP?

You can download the paper here or by clicking on the photo of the cover above.

I hope that the answers to these questions provide a useful basis to help communicators in consideration of their own efforts to talk about medicines in today’s communications and regulatory environment.

The paper has its limitations.  For example, the most obvious limitation – since we do not know what proportion of communications by industry is divided between digital and non-digital efforts, the data cannot say whether or not digital is over or under represented. In other words, if 50% of the communications effort is in digital, and it gets 50% of the regulatory action violations cited by FDA/OPDP, then it is proportional – however we have no way of knowing that context.

In the coming weeks, you will find additional analyses from the OPDP action letter data base here on Eye on FDA.

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