Weekly Roundup 4.24.15

It is that time of year when the temperatures can range by 30 degrees from morning until afternoon. The pollen counts are high and already sudden storms appear on the horizon to dump a lot of rain and then move on as if nothing had happened. One marvels that the year is already one-quarter passed. Vacation plans are made for summer. Blooms are blossoming in rapidly growing numbers. Bugs are not yet out. Every so often, it is a good time to stop, look around and realize that life is good.
And here is a bit of what happened this week:

  • FDA and Device Data from Outside the U.S. – Foreign clinical trials can be less expensive than those in the U.S. but circumstances around the conduct of those trials can vary. This week FDA announced a draft guidance related to devices called “Acceptance of Medical Device Clinical Data from Studies Conducted Outside the U.S. and has opened a docket that is scheduled to close on July 20, 2015. The agency said that the guidance describes the special considerations when using data from outside the U.S. and while the draft does not describe new policy, but describes FDA’s existing approach to this issue.
  • FDA Warns on BMPEA – This week the agency sent five Warning Letters (non-OPDP) to companies regarding products labeled as dietary supplements which contained the substance Beta-methylphenethylamine – also known as BMPEA. As the letter states, a dietary ingredient is a vitamin, mineral, herb or other botanical and BMPEA is not and therefore products containing it are misbranded if labeled as a dietary supplement. In addition, it was noted that BMPEA is not an approved food additive, nor is it included in substances with GRAS (generally recognized as safe) status. The list of warning letters can be found here and a specific example of one of the letters here. The sending of multiple letters by the agency could reasonably be interpreted as enunciating or illuminating a policy position.
  • Acting FDA Chief Speaks – Just 14 days into his new role as the Acting Commissioner for FDA, taking the place of former Commissioner Margaret Hamburg, Dr. Stephen Ostroff spoke at the annual meeting of the Food and Drug Law Institute. He acknowledged the role of the former Commissioner in leaving the agency in a stronger position than when she assumed her office. His remarks were entirely focused on the accomplishments of the past year – the approval of 51 new molecular entities last year, including more orphan drugs than at any other time and 17 of which were “first in class”, and two-thirds of which were approved in the U.S. before anywhere else and noting that a large number of them occurred under one of the agency’s expedited programs for new therapies; citing the role of FDA in assisting families seeking access to promising investigational drugs; bolstering the role of women and minorities in clinical trials, and several other achievements.

That’s it for me this week. Have a pleasant weekend. Enjoy.

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The Regulation of Search

Where are we when it comes to the regulation of search and digital media by FDA? After issuing some guidance documents, we know a little more about FDA’s approach to digital and social media, but there are still many outstanding questions. One of those may reasonably be related to search – the means by which users of the Internet find their way to your digital properties.

When FDA chose to begin addressing the regulation of digital and social media in November 2009, the framework in which the discussion occurred was set up to answer five basic question areas:

  • Responsibility – for what communications are companies responsible and accountable for in digital and social media?
  • Limited Character Spaces – how can this be negotiated while meeting regulatory requirements?
  • Misinformation – how can companies correct misinformation?
  • Links – how are they best used?
  • Adverse Events – how to handle?

It is these five topical buckets that have formed the conversation around the regulation of digital and social media. Many thought there would be a single guidance document to address social media, but FDA instead has handed out spoonfuls of regulatory insight through a penumbra of guidance documents and warning/untitled letters over a great span of time. In some ways, this paradigm for the conversation has been frustrating and in some respects, it is useful.

FDA wanted to avoid discussing platform-specific regulation – so, for example, there is not a Facebook focus. Rather, various areas of responsibility are spelled out so that using any platform (one here today or emergent tomorrow), one would have an idea of regulatory parameters in which to operate.

So what is the question on search? Specifically, how should stakeholders approach the optimization of a digital property for search?  That is a topic that would seem to fall in the responsibility bucket.

Responsibility, in turn, is a broad topic and is not addressed in a single document, but there is certainly a good deal to say on the matter.  For example, in the Draft Guidance Document on Correcting Misinformation, the agency states parameters when companies are responsible for content generated by third parties and when they are not. But responsibility is discerned not through a single guidance, but through the range of discussion by the agency regarding digital communications.

While not in guidance form, the answer regarding the question of responsibility and search may have been at least partially provided in a recent Warning Letter sent not by OPDP, but elsewhere from within FDA. This letter was directed to a company that the agency said was promoting an non-prescription product as a drug. The majority of the letter is directed at claims made with respect to the products. But one portion of the letter addresses the use of specific meta tags used to direct search to the sites – tags that related to disease specific conditions that helped support the agency point of view with relation to the promotion of products that were in fact being promoted to address specific diseases and conditions.

In short, while not from OPDP, FDA seems to make clear here that responsibility includes communication that a company generates to direct web searchers to a particular site. Specifically methods of search enhancement that drive traffic from Internet users seeking information on topics that may be off label could be problematic. That may seem obvious, but the issuance of a letter mentioning the meta tag use specifically informs stakeholders that the agency is looking at this.

This is one of many examples of how insight into understanding that the regulation of the use of social and digital for industry is a an on-going process represented through the evolution of thought as expressed not just in guidance documents, but in enforcement patterns requiring the many stakeholders in this area to look at and understand the whole picture.

Just a reminder that on the Eye on FDA blog site, there is a special page reserved for a comprehensive look at developments in the regulation of digital and social media. You can check it out here.

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Weekly Roundup 4.17.15

A few weeks ago it snowed, this week the lawn mowers were revved up. The car is covered in pollen. The cherry trees in DC have peaked. The ranks of tourists have swollen. Taxes have all been done and filed – hopefully. In short, Spring is well underway. Too soon, I fear, we will be complaining about the heat and humidity, but in the meantime, there is lots to enjoy.

I am working on some updates and fun things coming up.  In the meantime, here are a few things of import from the week past:

  • IMS Releases Report on Medicine Use – The IMS Institute for Healthcare Informatics announced the release of its report – Medicine Use and Spending Shifts: A Review of the Use of Medicines in the U.S. in 2014 which contains a wealth of data and information regarding the pharmaceutical industry and patient use of medicine. Among opther findings, the report found that total spending in the U.S. increased 10.3 percent on a real per capita basis in 2014 in addition to the fact that it was a year in which the highest number of transformative medicines were launched in a 10 year period. The numbers are also there tracking the proportion of specialty medicines (up in profile) and prices for branded products which rose an average of 13.5 percent (on an invoice basis) or 5-7 percent when accounting for off-invoice discounts and rebates. The report covers three primary subject matter areas: costs and spending; demand and payment and changes in treatment.
  • New Heart Failure Approval - FDA announced this week that it was approving Amgen’s Corlanor® (ivabradine) which is intended for use in certain people who have long-lasting (chronic) heart failure caused by the lower-left part of the heart contractions. It is indicated for patients who have symptoms of heart failure that are stale, a normal heartbeat with a resting heart rate of at least 70 beats per minute and are also taking beta blockers at the highest does they can tolerate. The drug is thought to work by decreasing heart rate and is the first approved drug in this class. It was reviewed under FDA’s priority review program and had fast track designation and will be dispensed with a Medication Guide. The company’s press release is here.
  • Generic Approval in Multiple Sclerosis – In another approval announced this week, FDA emphasized the message that a generic approval for Copaxone (glatiramer acetate injection) for the treatment of relapsing Multiple Sclerosis met the same rigorous standards of quality as the brand name drug. The announcement stated that Sandoz received the agency approval for marketing and the agency noted in its release that “the agency requires appropriate information to demonstrate sameness for complex active ingredients such as glatiramer acetate” and that FDA had established a thorough scientific approach. For additional coverage and background see the reporting from Ed Silverman on Pharmalot.

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

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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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