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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Local Ballot Initiatives Impacting Health and Healthcare

There is a good deal of commentary about what happened at the nationally in this year’s election cycle. But a good deal happened at the state level as well – things that will impact healthcare and may influence how other states respond. In addition, there were state issues that were voted on that could have an impact on the national debate of some specific topics. All in all, according to Ballotpedia, there were 154 measures available for voters to consider across the states this November, and a number of them touched on healthcare.

In that capacity, here are a few the state ballot initiatives that are of note:

  • Prop 61 – California – Pharma Pricing – This proposition would have required state agencies to pay either the same or a lower price for prescription drugs than the U.S. Department of Veteran Affairs .  The measure was seen as a focal point on the issue of pharmaceutical pricing. The measure failed with 54 percent against to 46 percent in favor.
  • Amendment 69 – Colorado – Single Payer - This measure would have created a single payer healthcare system called ColoradoCare that would provide universal healthcare for residents of the state and financed through a tax on wage and non-wage income. The measure was soundly defeated by nearly 80 percent against to 20 percent in favor.
  • Proposition 60 – California – Condoms in Pornography – Certainly one of the more unusual ballot initiatives voted on this cycle involved a proposal to require actors in pornography films to be given condoms to wear during performances and would further have required the makers of the films to cover the costs of medical screenings and examinations. The measure failed with nearly 54 percent against compared to 46 percent in favor.
  • Proposition 106 — Colorado – End of Life – This ballot measure sets up standards that would allow residents to legally seek and obtain assistance to end their life through the self administration of drugs when facing the circumstance of a terminal illness. The measure passed by nearly 65 percent in favor to 35 percent opposed.
  • Multiple – Medical Marijuana - There were a number of marijuana legalization ballot initiatives, some of which were about recreational use, but several of which were specific to medical need -
    • Arkansas Issue 6 – allows medical use of marijuana for 17 specific qualifying medical conditions, passed 53 percent in favor with nearly 47 percent opposed;
    • Florida Amendment 2 - would allow the regulation of marijuana by the state and use by patients with qualifying conditions such as HIV/AIDS, glaucoma, Parkinson’s Disease, PTSD, ALS, MS, cancer and epilepsy- passed 71 percent to 29 percent;
    • Montana Medical Marijuana Initiative – would amend existing law passed by the legislature to remove existing numerical restrictions on medical marijuana providers who had been limited to the number of patients they could serve, among other things – Passed by nearly 57 percent to 43 percent;
    • North Dakota Medical Marijuana Legalization Initiative – Sets up regulation of cultivation and distribution for medical marijuana for patients of specific medical conditions passed by nearly 64 percent to 36 percent.
  • Soda and Sugary Beverage Taxes - While a significant yes regarding the use of medical marijuana, there was also support for a tax to be placed on soda and beverages containing sugar in four municipalities. The taxes work by leveraging a tax on the ounce for specified types of beverages and the municipalities where the measures passed primarily in California – San Francisco (62 percent in favor, 38 percent opposed), Oakland (61 percent in favor and 39 percent opposed) and Albany (71 percent in favor, 29 percent opposed) and one in Boulder Colorado (don’t have the percents).

All of percentages were gleaned from the site Ballotpedia and were rounded up.

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FDA Seeking Even More Input on Character Space Limitation

This week FDA published a notice in the Federal Register seeking comment on the proposed collection of information regarding research entitled “Character-Space-Limited Online Prescription Drug Communications“. The notice states that the objective of the research is to test whether a link to prescription drug risk information can effectively convey the risks associated with a drug when benefit claims about that drug are made within the character-space-limited communications used in prescription drug promotion.

In other words, if a tweet or small online ad mentions that Drug X Cures Toenail Fungus will a person run out and get their doctor to give them that drug without clicking on the link to warning information? Is this development a good one or one to be concerned about?It sort of depends on the agency’s motivation.

On the one hand, FDA’s curiosity regarding the matter of balancing risk information with benefit information in a character-space-limitation setting is to be commended. It demonstrates a healthy interest in exploring the realm of social and digital media – something the agency has been grappling with since 1996 when it held its first meeting on dealing with the newly emergent Internet. Understanding the implications of social and digital media has not come easy to FDA and the menu of guidance documents promised in 2009 at a two-day public hearing on the topic has produced only a partial response on the part of the agency. In fact, patients, physicians and pharma companies have moved far ahead, and FDA has been struggling to catch up for many years.

The issue of character-space-limitation is one of the areas in which FDA has actually shed some light by producing a guidance document on the topic in June 2014. Is the agency trying to crystallize its thinking in that regard? Are they looking for evidentiary support to go back on the position they took in April 2009 regarding the “one-click rule” – the notion that risk information could be included a click away – when they issued 14 untitled letters in a single day about the use of links to third party information? If so, that would be a good thing.

But on the other hand, one might question whether so much attention to this particular aspect of social media use by pharma is actually warranted.

In the first place, between the patient and the prescription there is a learned intermediary – the doctor. The real world is made up of many variables that will impact whether or not risk information is picked up. And the real world is made up of many attempts to alert patients to risk information, which may or may not be particularly useful. Right now many prescriptions are delivered with pages and pages of information about a drug, but how many people actually read and absorb that information? Are those inclusions really impactful? (I personally doubt it). Do people read them once? Do they read them every time they get a re-fill?  How people get risk information, how they perceive it and act on it and how other factors figure in is complex. In short, a study to discover the use of a single link to risk information is going to tell you a small part of the picture, but it is not going to tell you the whole picture, or anything looking like it.

In the second place, FDA might better spend its time addressing the gaps in guidance around social media – for example the Use of Links to Third Party Sites guidance that was on the guidance agenda not only this year, but last year as well. Or what about adverse event reporting, listed as one of the original five questions posed during the 2009 public meeting on social media?

Finally, in fact, while pharmaceutical companies have many Twitter feeds (I have a database that contains all of the feeds of which I am aware and there are over 300), the overwhelming majority of them are not product specific, but are oriented to corporate news, recruitment and advocacy. You can see the Twitter list here.

The decision to delve further into the question of a link to risk information is important, but the question has been around for a long time. Let’s get it answered and move on.

If so inclined, you can submit comments to the docket on this matter here. And for an overview of FDA activity around social media, there is a tab on the blog devoted to resources located here.

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Weekly Roundup 11.4.16

We are almost through it!  Just a few more days.

In the meantime, the more enjoyable aspects of autumn, chilly nights, fires in the fireplace, and brilliant leaves are all upon us. Soon the end of year holidays will be upon us. In the meantime, a few interesting things from the week:

  • OPDP Issues Fifth Warning/Untitled Letter of 2016 – To say that it has been an anemic year from OPDP’s enforcement letters is a bit of an understatement. This week the agency issued its fifth of the year and if it does not double that number in the next few weeks, it will be the lowest level of enforcement seen from this office of FDA. The untitled letter cited a video for Oxtellar XR – an extended release tablet indicated for adjunctive therapy of partial seizures in adults and children 6-17 years. The product has some specific risks associated with use in the label, including warnigns of anaphylactic reactions among others. The video was cited for a lack of adequate diretions for use because of the specific language used in the video that OPDP felt broadened the indication of the compound to include all seizure types and because the presentation did not present risk information in conjunction with the benefits. Of the five letters issued this year, four were Untitled Letters and one was a Warning Letter.
  • AdComm Gives Up Vote on Nocturia Candidate – A meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee voted 14-4 in favor of the benefit/risk profile of SER120 (desmopressin nasal spray) for the treatment of nocturia – a condition in which adults awaken two or more times a night to urinate. If approved, it would be the first treatment approved for nocturia, though there have been previous attempts.  In January 2015, a tablet formulation put forth by a different company and reviewed by a different advisory committee, resulted in a negative recommendation.
  • How Much of the Economy is Regulated by FDA? For many years, many people (including this people) have touted the characterization that FDA regulates one-fourth of the U.S. economy – or in other words, regulates 25 cents of every dollar spent. In a blog posting this week, FDA put that characterization to pasture with a new study by the agency’s staff economists that takes it down a peg – with FDA regulating one-fifth of the economy, or 20 cents of every dollar spent – a level that has apparently held steady over the past five years. The study was done analyzing expenditure data from the Bureau of Economic Analysis (BEA). I stand corrected.

Enjoy the weekend everyone. And get out and vote, if you haven’t already.

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