Warning and NOV Letter Summary – 1st Quarter 2015

In the years past when the Office of Prescription Drug Promotion (OPDP) issued Warning Letters (WL) and Notice of Violation (NOV) letters with regularity, it was the custom here at Eye on FDA to review them on a quarterly basis. In particular, it was prudent to look for any evolution of thought with respect to enforcement matters, particularly regarding social media since the agency was dragging its feet in producing any guidance.

Last year however, OPDP produced so few letters that quarterly updates did not seem worthwhile. During the first quarter of 2015, the agency produced only three – not a bumper crop, but worth looking at nonetheless.

As noted in a previous posting (Is Bigger Safer, OPDP Enforcement Patterns and Company Size), recent letters were not aimed at large, well-known companies and in fact, that has been one of the most notable trends in enforcement in recent months.

The three letters from this quarter addressed three communications vehicles – one involving a video and two involving web sites. All three were NOVs and so this quarter so no WLs issued and there was no commonality in the therapeutic purpose of any of the products.

During the first quarter of 2015, not only were there few letters, there were few violations cited within these letters. Many times a letter will contain multiple violations, but this quarter the three letters cite  a total of only seven violations. During the first quarter of 2014, OPDP had produced only two letters – also covering seven violations and in 2013 there were only three letters covering nine violations. By contrast, the first quarter of 2012 saw eight letters with nineteen violations.

Also notable was the type of violations – Since tracking and reporting on the letters here at Eye on FDA, the most common violation has consistently and overwhelmingly been the Omission or Minimization of Risk, but this quarter, it was cited only once.

Violations categories and the number of violations from this quarter tracked in the Eye on FDA database include:

  • Omission or Minimization of Risk (1)
  • Superiority Claim
  • Overstatement of Efficacy (1)
  • Unsubstantiated Claim (1)
  • Broadening of Indication
  • Promotion of an Unapproved Use
  • Promotion of an Investigational Compound (1)
  • Other – which is a catchall for less common violations (3) – 2 of which were Omission of Material Fact and 1 of which was Lack of Adequate Directions for Use

Other than the fact that there were so few letters and so few violations, this quarter was also notable for the fact that one letter contained four of the violations. Another notable aspect was the fact that one of the violations was for Promotion of an Investigational Compound, which is a relatively rare violation. In this letter, the agency cited numerous statements made on a web site that stated that the product was “easy and safe” among other things. Finally, the final of the three letters from this quarter provided an example where it the agency cited a company when it emphasized the fact that it was the only synthetic alternative to animal-based products which inferred superiority.

The lack of activity related to enforcement by OPDP unfortunately leaves less insight into the agency’s thinking around evolving issues, particularly in the area of digital media where guidance has been so long in coming and short on substance. Let’s see what the next quarter brings.

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Weekly Roundup 4.3.15

March winds bring April showers. April showers bring May flowers.  May flowers bring pilgrims. Ha.

It is April – 2015 speeds at a breath-taking speed. The yard work continues to wait, but the daffodils do not and have arrived in time for this holiday weekend.

On a more official front, Dr. Margaret Hamburg, certainly an effective presence as FDA Commissioner these past six years, gave her final public speech last Friday at the National Press Club. Prior to her arrival, the agency hungered for steady leadership. We wish her well.

In the meantime, here are a few other things that occurred this week of note:

  • Stepping Up with Opioid Guidance – A few weeks ago, you may have read that FDA was coming under some Congressional pressure to come through with a final guidance on the development of opioid products with abuse deterrence and reportedly if not delivered, there was some funding at stake. This week the agency announced delivery of an opioid guidance. The agency said that while the technology is evolving it was issuing the guidance was meant to assist those developers wishing to apply a deterrence factor. No mention of the Congressional boost to the timing, but perhaps social media guidance advocates may want to take notes.
  • AdComm to Discuss Blood Donor Policy and Gay Men – In the wake of the HIV epidemic that began in the early 1980s, FDA put into place a lifetime ban on donations from gay men/men who have had sex with men if sex had occurred at any time since 1977. Late in 2014, FDA Commissioner Hamburg announced a proposed change in the policy to defer such donations if sexual relations had occurred within the past year. The agency is announcing that the topic will be reviewed, among other agenda items, at an upcoming Blood Products Advisory Committee to be scheduled for May 13.
  • AdComm Name Change – For those of us who watch FDA’s advisory committee meetings closely, take note that the Anti-Infective Drugs advisory committee has taken on a new name and will now be known as the Antimicrobial Drugs Advisory Committee.  Notice of the change is being noted in the Federal Register and was effective March 4 as can be seen here on the Committee’s home page.

That’s it for me this week folks. I hope you all have a wonderful weekend. Be safe and well.

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Weekly Roundup 3.27.15

Another busy week – hence a day late with the Weekly Roundup.

This week, I cleared one of the flower beds of the dead stems from winter and filled three lawn and leaf bags with leaves and stems.  They took them away today.  It is a good feeling. There are about 100 bags left to fill. That is a bad feeling.

It is the time of year where there are crazy temperature ranges. It was 75 degrees this week here in Washington and there is a call for snow mixed with rain. There was a thunderstorm forecast. But the daffodils are up and about to strut their stuff.

It was a relatively quiet week comparatively speaking on the FDA front, but here are a few tidbits.

  • FDA Approves Inhalation Anthrax Treatment – This week the agency announced its approval of Anthasil in inhalation form to treat inhaled anthrax exposure in combination with other appropriate antibacterial drugs after rare exposure to infected animals or other exposure to spores. This product had been purchased under the authority the Biomedical Advanced Research and Development Authority (BARDA)  - and the approval by FDA means that emergency authorization for its use would no longer be required. The nature of the condition being studied meant that this approval was based on animal studies and the product is made from the plasma of persons who have been vaccinated against anthrax exposure because their plasma has antibodies that act to neutralize the toxins generated by exposure.
  • Blood Pump Approval – The agency announced approval of a new blood pump system for use with patients suffering effects of coronary artery disease (CAD) who are undergoing high risk procedures such as stent placement or angioplasty, known as high risk percutaneous coronary intervention. The pump is introduced prior to a procedure through a catheter. Heart function is measured and externally monitored and the pump is employed as necessary to help maintain stable heart function during the procedure. The company press release can be found here.
  • Draft Guidance Development and FDA – For those who have waited for the development and issuance of a specific guidance by the agency – and waited, and waited, and waited, you may think it is just you being impatient, or just your guidance that is taking a long time to develop. In that case, you may want to take a peek at the nice overview Ed Silverman did at Pharmalot that describes just how long some guidance documents have taken to develop. As often said here, these guidance documents, along with warning letters, are the only windows into the agency’s current thinking. With the documents taking a long, long time and warning letters having slowed to a trifle the result is less transparency, not more.

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

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Is Bigger Safer? OPDP Enforcement Patterns and Company Size

Eye on FDA has frequently carried overviews and summaries of enforcement by the Office of Prescription Drug Promotion (OPDP) through the issuance of Warning and Untitled Letters (regulatory action letters). These letters, along with guidance documents that are occasionally issued by the agency, are one of the ways that industry can gain insight into FDA’s thinking on a wide array of topics, including the regulation of speech related to drugs and biologics.

In the past few years, enforcement by OPDP has dropped off considerably – at least as measured in the number of regulatory action letters that were issued. Not so very long ago, the agency used to issue scores of letters in any given year – in 1998 there were over 150 letters issued. Thereafter the number of letters fell off though in 2009 – 2011, there was a slight increase. But then last year, OPDP slowed to a crawl, sending out letters to ten companies, less than half of the 22 sent the previous year and only about a third of those sent out in 2012.

But looking beyond the numbers at the letters sent the past few years, one can also readily see that the recipients of the letters tended to not be the pharma and biotech companies that you might readily be able to name. Smaller companies seemed to be predominant when it came to enforcement.

To see if this impression was correct, I used as a yardstick of company size the Pharma 50 published in Pharmaceutical Executive which lists the top 50 companies by sales.  I cross-referenced the names there with the names of recipients of the regulatory action letters over the past few years from my Warning Letter Database.  Here is what I found:

  • 2015 – There have been only three letters issued by OPDP this year. Of those three, zero were included in the Top 50.
  • 2014 – Of the 10 letters, one (10%) was received by a company in the Top 50.
  • 2013 – Of the 22 letters in this year, five (23%) of the letters were sent to companies in the Top 50.
  • 2012 – During this year, there were 28 letters sent out by OPDP ten (36%) were sent out to the Top 50.
  • 2011 – OPDP sent out 31 letters, eight (26%) of which went to companies in the Top 50.

That is a total of 94 letters in all.  Twenty-four (25.5%) of which went to companies in the Top 50.

What does that say? On its face, nothing conclusive. Large companies are likely to have much more promotional language about more products but also likely to have more experience and probably more internal controls than less experienced companies.

However, one note – in 2010, there were 52 letters issued by OPDP.  Half of them went to companies in the Top 50.

Perhaps the reason is that there have been a number of emerging companies on the horizon, so the pool of smaller companies is expanding. In any case, it has represented an interesting trend of note in OPDP enforcement.

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Weekly Roundup 3.20.15

There really is more to Eye on FDA than the Weekly Roundup, but this month you wouldn’t know it. Busy schedule combined with a few health issues have resulted in a diminished output, hopefully to be put right now that Spring starts today.  As to that though, you wouldn’t know it to look around Washington, D.C. or anywhere around the East Coast I should think – where we see snow falling outside the window today, though Spring does not officially start until 6:45 this evening here. And tomorrow promises sunshine and moderate temps.

Here is a bit of what happened this week:

  • FDA Approves New Drug for Bile Acid Synthesis Disorders – Another in what has been a long string of FDA approvals for new products that treat rare disorders, the agency announced this week approval of Cholbam for the treatment of pediatric and adult patients with bile acid synthesis disorders due to single enzyme defects. People with this disorder experience a reduced bile flow and accumulation of potentially toxic bile acid intermediates in the liver and malabsorption of fats resulting in possible liver injury.
  • Opioid Abuse Hearing – The House Energy and Commerce, Subcommittee on Oversights and Investigations announced that it has set March 26 for a hearing “Examining the Growing Problems of Prescription Drug and Heroin Abuse:  State and Local Perspectives“. The slate of speakers has not yet been posted but will be found here. Also this week in related news, it was reported that members were applying pressure to FDA to issue its guidance on abuse-deterrent opioids.
  • Ebola Vaccine AdComm - A meeting of the Vaccines and Related Biological Products Advisory Committee was announced this week for May 12 to consider the development and licensing of vaccines for Ebola. When posted, meeting materials will be found here. On a related note, there was also a posting on FDA’s Voice Blog called Turning the Tide on Ebola describing on the ground work in Liberia.

I have some good stuff coming up if I can just get time to tend to it. In the meantime, enjoy this first weekend of Spring!

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