Weekly Roundup 12.16.16

It has been a while since there has been a Weekly Roundup posting, primarily because FDA has been fairly quiet of late. In fact, during October the agency issued only 3 press releases and the same for November. Certainly lots is happening around the agency though, like the passage into law of the 21st Century Cures Act. This week we’ll have some things of note that the agency has done as well as a few updates on the changing environment.

  • FDA Announces Eczema Approval – It has been a year short on drug approvals compared to last year, but FDA added one to the list for 2016 this week in approving Eucrisa, a phosphodeisterase 4 (PDE-4) inhibitor being indicated for the treatment of mild to moderate eczema in patients two years and older. According to the company press release, there has not been a new prescription available for patients in over ten years. While overactive PDE-4 has been shown to contribute to the condition, the specific mechanism of action is not known.
  • FDA’s OPDP on the Move! – After a year that was relatively quiet on the enforcement front, Eye on FDA reported this week on two untitled letters issued by the Office of Prescription Drug Promotion (OPDP) related to DTC advertising and risk information. Then the following day a third and fourth letter was posted, this time both Warning Letters, also involving risk information (the most common violation cited in OPDP letters). This means OPDP has issued nearly as many letters so far this month as have been issued all year by that office.

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

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OPDP Makes a Point on Risk Info and DTC (Updated)

The Office of Prescription Drug Promotion (OPDP) has been particularly low-key this year when it comes to visible enforcement actions expressed through the issuance of Warning or Untitled letters. Up until this week, the office had issued only 5 letters so far this year. That represents a dramatic drop-off in enforcement over the years. In fact, if no more letters are issued this month, this year will represent the least amount of Warning/Untitled letter action in two decades.

That said, this week OPDP decided that it would make a point about the presentation of risk information in broadcast Direct-to-Consumer advertising (DTC) when it posted two letters issued December 12. You can see the letters here and here.

For some time now, the agency has been engaged in research to assess how risk information comprehension is perceived by audiences in DTC advertisements. Recent efforts have focused on evaluating the use of animation in these ads, but earlier the agency was collecting information on the impact of distractions during the viewing of such ads. The agency has also been looking at the impact of ad exposure frequency in processing risk and benefit information.

The letters this week would appear to be a by-product of that research. While some might think that it would be logical for the agency to issue a written guidance that reflected the results of such studies and thereby better inform industry as to regulatory guardrails.  In 2009, a draft guidance did lay out principles for presenting risk information in DTC ads.

It would appear that OPDP is using the letters to make a point, perhaps to reflect the study in which the agency has been engaged. Both of the letters involved  the same communications vehicle – DTC ads – and both cited a single violation – characterized as false or misleading risk presentation.

It is noteworthy that most risk violations in past letters have been the omission or minimization of risk information. Also most letters cover more than a single violation.

In these letters the single violation for each had to do with the conveyance of risk information and both were under similar circumstances. The letters stated that during the “major statement” – or the portion of the ads that convey the risk disclosures – there were distractions such as loud music and attention grabbing visuals that were unrelated to the risk subject matter. OPDP is making the point that the conveyance of risk information in DTC should not be clouded by visual or aural circumstances that are not related to the subject of risk.

Apart from the fact that enforcement has been so inactive, this week’s regulatory action letters were not only interesting from a few other the perspectives.  For example, the past few years the overwhelming majority of letters have been directed at smaller pharmaceutical companies – not ones appearing in the top 50 by sales volume. However these two letters were both directed at larger companies both within the top 25, as might be expected given this involved DTC broadcast television vehicles and therefore break with the pattern.

We’ll be on the look out for any updates to this year’s regulatory enforcement and provide an overview of 2016 in the new year.

Note:  This posting has been updated as of December 16, 9:24 AM. The original version did not reference the 2009 draft guidance document on presenting risk information and suggested that the letters were issued as a result of the research prior to guidance. A reader pointed out the error and the posting has been corrected to reflect the fact that there has in fact been prior guidance on this subject that outlined the principles addressed in the letters.

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FDA – Fewer Approvals, Less to Talk About in 2016

As the year ends, it is time to look back at what has occurred during the year and what hasn’t. Let’s begin with approvals. I noted recently in a Tweet that during the months of October and November, FDA had issued a total of only 6 press releases – 3 in each month. To put that in context, the monthly average for agency press releases during 2015 was 14.

The October/November period of relative quiet may just be an anomaly, but in fact overall during 2016 FDA has had less to say than it did the previous year. During  the first 11 months of 2015, FDA had issued a total of 146 press releases compared to the same period for this year when the agency issued only 112 – a 25 percent drop. In short, FDA has had less to say so far this year than it did last year.

A focus for FDA in 2015 involved approvals of new molecular entities – a record-setting 45 last year. To put that in perspective, between 2006 and 2014, new molecular entity approvals averaged 28 per year. During 2014, approvals were also high, coming in at 41.

But unless December gears up to be an exceptional month for such approvals, 2016 is not shaping up to be in the same league. At the mid-year point Eye on FDA check, it did not seem that FDA was on track to match last year’s robust approval rate. And in fact, so far in 2016 there have been only 19 approvals of new entities listed by the agency.  This is not only far short of last year, but unless at least 3 more approvals are announced this month, it will be a year with the fewest new entity approvals since 2010.

FDA of course approves more than new entities. There are also approvals of drugs that are not new molecular entities and many of those approvals (but not all) are announced in FDA press releases. Using press release announcements as a surrogate to measure that activity, approval actions still appear down. During the first 11 months of 2015, FDA announced via press release 69 approval actions involving drugs or biologics. By contrast this year during the same time period, there were only 27 such announcements. Of those, some included expanded approvals of already approved drugs, an OTC switch and a generic approval.

Could December be a comeback month?  It often is a period active with approvals. In 2015 there were 8 approval announcements for drugs or biologics in December. In 2014 there were a whopping 11 press releases about approvals, but in 2013, there were only 5. So while December could be a big month for year-end announcements, it is not a sure thing.

This week President Obama signed into law the 21st Century Cures Act and one of the chief aims of the legislation is to ease the way for the approval of new drugs, including drugs for rare diseases. While last year was a banner year for approvals, it would appear that 2016 may be a proof point for advocates of the law. In the meantime, we’ll wait and see if December brings a last minute rush of approvals (and releases) and in the new year, provide a detailed re-cap of press releases from FDA for 2016.

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New Directions for FDA, Part 2 – Regulatory Matters

In Part 1 about change facing FDA, we looked at the 21st Century Cures Act and some of the change that would be in store for FDA. But in this post-election cycle, there is more than pending legislation that could bring change to FDA. There is the regulatory side of things as well.

Just prior to the election, the President-elect made the statement that he would be aiming to cut 70-80 percent of government regulations. While presumably he is aiming at regulations put into place that affect business and finance practices and enforcing legislation such as Dodd-Frank and also at EPA environmental regulations.

While remarks made during the campaign indicate that the pharmaceutical industry is a concern of his with respect to pricing, when it comes to matters outside of pricing, the new Administration may be willing to alter regulations that it considers to be in the way of businesses doing their business. Therefore, it is not inconceivable that a part of the aspirational regulatory elimination that could result might be aimed at at least some of the regulations issued involving the agency that regulates one in five of every dollar spent in this country – the Food and Drug Administration.

FDA naturally involves a great deal of regulation. What might be prime targets for change?

  • Off-label Promotion – Much has been done and written over the years about what industry can and cannot do with respect to off-label promotion, making it one of those issues that is never completely settled. Industry has often made clear a desire a more loose approach with respect to off-label promotion and has successfully pushed back against FDA stringent position on the matter through the courts, opening the way for a greater sharing of scientific information regarding investigation into additional uses for approved medicines. At a recent two-day hearing by FDA entitled Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products, some within industry reportedly made the case that they should be allowed to share off-label information with payers. Opponents expressed concern that by-passing FDA in this manner could limit physician choice in prescribing. Notably, this is an issue not addressee by the 21st Century Cures Act.
  • Promotion in General – Discussion of off-label usage is one aspect of FDA regulation over the commercial speech related to its medical products, but there are many, many more. It is not inconceivable that a new FDA commissioner might make enforcement even less of a priority than it has been from the Office of Prescription Drug Promotion (OPDP) – the office which oversees promotion and advertising of approved medicines and devices. As noted many times on this blog, promotion has been fairly anemic the past few years – and no more so than this year with the issuance of a mere five (5) letters issued by that office. OPDP has implied enforcement has taken other forms, but not offered any transparency whatsoever regarding what activity that entails. While anemic, it is possible that enforcement over promotional activities may become even less of a priority in an Administration that regards regulations as too abundant and that promotes its intentions as “business friendly”. In short, promotion of unapproved drugs, unsubstantiated claims may find a less strict environment.
  • Guidance - That may translate not only into less enforcement, about promotion but less guidance about promotional activities as well. It has taken FDA years to enunciate guidance with respect to communications via social media. And while such guidance has been very difficult to pry out of FDA and OPDP (still waiting on many aspects, including fleshed out thinking on the use of links related to risk information and adverse events reporting left vague and incomplete by guidance documents so far), more guidance in this area may not be a priority for the incoming Administration.

There are likely many other ways in which a regulatory cutting zeal on the part of the new Administration might impact FDA – there might be fewer inspections for example. But the nature of this blog is to focus on those issues that impact communications and so speculation will go no further. The game of prediction – as the election cycle demonstrated – is a tricky business and one goes out on a limb when speculating on specific outcomes. But one safe bet – if there is truly a desire to cut regulations, the agency that oversees one-fifth of the US economy is not likely to be exempt.

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New Directions for FDA, Part 1 – 21st Century Cures

One of the often stated priorities for lame-duck Congress has been voting on the 21st Century Cures Act. In a press release from Saturday, November 26 from the House Energy and Commerce Committee, the House is set to vote on a new version of the bill following release by House and Senate health committee leaders on a “final” bill.

Originally passed in the House in July 2015 by a lopsided vote of 344-77, all attention then went to the Senate side for passage. And then there was a long wait. This year in April there were statements made that a bill could be out of committee within the week and ready for Senate action. It did not happen. At the beginning of September, there was some talk that it would get attention before the month was over. Now it comes to the lame duck session after the election and media reports that Senate Majority Leader McConnell has termed the bill a priority.

Among other things, the Cures Act seeks to liberalize the way FDA goes about regulating the approval of and access to drugs and biologics through a number of mechanisms. In addition the new final bill has something in it for just about everybody, including funding for the Precision Medicine Initiative for NIH, a boost in funding for FDA, $1 billion in grants to states to combat the opioid epidemic. Many claims are associated with the bill by its proponents – increasing research collaboration, incorporating patient perspective into drug development and the regulatory review process, providing new incentives for the development of drugs for rare diseases and provides support for the “cancer moonshot” initiative. In other words, it would all sound good. For some, too good.

The great milestone in moving FDA to speed approvals occurred during the early days of the AIDS epidemic when drug approvals were long and drawn out and mechanisms to speed approval were lacking. Through the course of activism and effort, FDA reforms allowed for new means to speed the process of approvals though Fast Track and Accelerated Approval programs. Subsequent reforms such as breakthrough therapy designation and orphan drug status designation have intensified the agency’s ability to bring innovative treatments forward for approval.

One might think that AIDS organizations – such a prominent proponent of earlier progress and liberalization of FDA’s approval process – might continue in support for reform offered by the Cures Act. But that is not necessarily the case. Before the 2015 House vote, co-founders of the HIV advocacy organization Treatment Action Group (TAG) joined with former FDA Commissioner Dr. David Kessler to pen an op-ed in the New York Times called “Don’t Weaken the FDA’s Drug Approval Process“. One of the several concerns raised in the piece was that biomarkers could be used to approve a wider set of treatments beyond those that are life-threatening or serious conditions and could allow clinical experience to replace data from well-controlled clinical trials, long considered the gold standard. In addition, TAG has issued an Action Alert for its member related to the lame duck session vote.

It is worth noting that in the wake of liberalizing the FDA approach to approvals in the 1990s, afterwards there were some high profile drug withdrawals that called into question whether or not drugs were being approved too quickly, at a cost to safety. The pendulum, it appears, has now swung again.

For critics it boils down to the issue of safety versus speed and whether or not the Act is even needed. FDA already is the gold standard and approves drugs more quickly than ever. New mechanisms to enhance approval such as Breakthrough Therapy Designation have been put into place and companies are utilizing such means. There were a large number of drugs approved in the past year for rare diseases. And FDA looked to patient experience in approving one drug.

TAG is by no means the only consumer group in opposition, but certainly one of the more interesting given the history. The proposed legislation is certainly one of the most talked about for the lame duck session of Congress and lobbying is reportedly in full swing. The House Energy and Commerce Committee is issuing almost daily press releases on the bill. There is likely a vote this week in the House on the new version and the Senate is said to consider it in December. If passed and signed into law, it represents perhaps only a part of the change that may come in the wake of the elections. More on that in Part 2.

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