Thoughts on Global Medical Affairs
In brief, Amarin has an FDA-approved indication to market its fish oil supplement as a treatment for very high triglycerides. It conducted a study that showed it lowered the triglycerides in moderately high patients but the FDA declined to approve the label extension because Amarin failed to prove a link to prevention of coronary artery disease. Amarin then informed the FDA that it intended to communicate the triglyceride lowering data to the market and the FDA informed them that it would consider any such communication off-label promotion. Amarin then sued the FDA for unfair restraint. Amarin was granted an injunction against the FDA, which appealed the decision.
In the latest development, the FDA has settled with Amarin, closing down the appeal before a ruling could be made to set clear precedence. In the settlement, which can read about here, the FDA agreed that Amarin could inform doctors of the studies supporting the fact that its product lowered triglycerides in a range of patients as long as the data presented was truthful. It also set up an “optional” provision in which Amarin can meet bi-annually with the FDA to review the material that they wish to present to ensure that the FDA will find that information truthful and any disagreements from these discussions would be sent to a court to make the final decision.
The FDA’s perceived fear of a precedence setting ruling is not going to go unnoticed. Already another pharma company, Pacira, is suing the FDA under similar circumstances, which you can read about here.
If this case is also settled, expect to see the floodgates open.
It is more than past due time for the FDA to provide clear guidance to industry on the use of truthful, non-misleading communication of scientifically valid data that is not supported by the label. When that guidance is finally offered, it will be a game changer for MA. We believe that most organizations will realize that the safest way to communicate such scientific data will be through the use of peer-to-peer communication driven by medical science liaison-type roles and this will lead to a major expansion of many MSL groups.
We will continue to follow this story. We would love to know what you think. Leave a comment.
In a court case that may have huge implications for pharma, a federal district judge in Manhattan ruled that the FDA cannot prevent a company from conducting off-label promotion if the promotion is truthful and scientifically accurate.
This ruling stems from the Amarin case that we discussed HERE. In that case, Amarin argued that the precedent set by the Caronia case (which we discussed HERE) allowed them to promote off-label if the information shared was truthful and not misleading. The FDA argued that the Caronia ruling was specific to those circumstances only and did not apply to Amarin. Judge Engelmayer wrote in today’s ruling that “…A fair reading of that decision refutes the F.D.A.’s view that the Second Circuit’s ruling was limited to the facts of Caronia’s particular case.”
While this only currently applies to the circuit in question, it is a clear precedent that will need to be addressed if the FDA intends to retain its current regulatory approach to off-label promotion. The FDA has not stated whether it intends to appeal but it did not appeal the Caronia ruling, a decision some pundits felt was made to avoid having a broader precedent set for allowing truthful off-label promotion.
This is an ongoing story but it could have some major implications for pharma and medical affairs. Stay tuned to this space for more developments as they occur.
Any comments or thoughts on today’s news? Click here to share them.
Have you had the opportunity to follow the Amarin lawsuit against the FDA? If not, a quick recap:
Amarin is literally a fish-oil salesman – they have fish-oil pills that are already FDA approved for the treatment of very high levels of triglycerides. They had conducted clinical trials to expand their label to patients with lower levels of high triglycerides. The FDA rejected their application. Amarin decided it wanted to share the results of those studies anyway since they were positive and sued the FDA for the right to share its data on off-label use.
The interesting part comes from the FDA response letter. Putting aside their primary concern that Amarin failed to work with them before suing them, the letter signed by Janet Woodcock went on to layout the condition in which Amarin (or for that matter any pharam company) can share off-label data.
First, the letter reiterated what we already know and have discussed: the reprint exemption to off label communication – distribute reprints from peer-reviewed journals, avoid some simple issues like highlighting only the “good” passages, and you are in the clear.
But then the letter goes on to say that Amarin can also write up and distribute its own summary of the results of their trial if the write up:
They go on to add that to protect against being misleading the company should:
While that is still a lot of hurdles, that is a long way from reprints only. And while these are NOT an official policy now, I think this is telegraphing what we should expect to see in the upcoming policies.
I particularly like the final bullet point which makes it clear that these topics need to be discussed by roles that sound very much like MSLs.
To speculate, if the FDA were to allow establish this as the policy, it would surely free up MA to proactively share both off label and label supportive information. That would be a big improvement for some MA organizations that deny all proactive sharing of off-label information.
You can find the letter HERE. The juicy bits begin on page 8.
What do you think? Click here to leave a comment.
Have you seen the new FDA guidance about disclosing risk in consumer-directed print advertising that came out in February? (You can see it here) Unless you are a gluten for FDA guidance-reading punishment, my guess is that you skipped this one since it seems to be commercially focused.
BUT, there is actually something that MA should be aware of and perhaps an opportunity to add some value to our commercial brethren. The focus of the guidance is straight forward – under current law print advertising has to also disclose risks, and the safest approach for disclosing that risk is to publish the full package insert (PI) along with the print ad. As we know PIs are a tough read normally, but when shrunk down to fit in a magazine they are almost unreadable and certainly mostly incomprehensible to the very audience they are supposed to be protecting – consumers.
This has not been lost on the FDA and the guidance linked to above was entirely focused on resolving this issue.
In an FDA survey, few respondents reported reading half or more of the brief summary presented in the traditional format. Of those who read at least some of the brief summary, 55 percent described it as hard to read. Over 40 percent of respondents in the survey reported they do not usually read any of the brief summary in direct-to-consumer prescription drug print advertisements.
The FDA realizes that the full PI is aimed at medical professionals and full of details that the vast majority of consumers don’t care about like clinical pharmacology or chemistry. So the FDA is suggesting that manufactures should have the flexibility to replace the PI with something they are now calling “consumer brief summary.”
What is a consumer brief summary? Per the guidance it is an explanation written in consumer-friendly language (ie. drowsiness not somnolence) that includes:
And this is where Medical Affairs comes into play. Now our commercial colleagues and their agencies are going to be needing to develop information that includes medical judgement, like:
These questions are great ones for Medical Affairs to either provide guidance, answer directly or gather information from practitioners during their interactions to answer these questions and others. Given the proper but strong firewalls between MA and commercial, this new guidance provides a value-added opportunity for MA to provide some guidance to commercial.
MA leaders may wish to discuss this topic with their commercial colleagues.
Do you have any thoughts on the new guidance? Leave them in the comments by clicking HERE and scrolling down to the comment box.
As I mentioned earlier, I am attending the DIA MSC meeting in Pheonix, AZ this week. The MSC has increased value this year because they have added a track specifically focused on MSLs. Through the hard work of the MSL Track Chair people Rebecca Vermeulen and Ramineh Zoka, as well as the hard work of all the presenters the MSL Track has had a terrific first day.
DISCLAIMER: My focus is on interesting information, I did not try to take verbatim notes and will not try to assign comments to a particular speaker. Any mistakes are mine alone.
In no particular order, some of things are found interesting included:
– A pill is poison unless the right information is wrapped around it.
– Tax Deductibility for Marketing and Sales expenses in Biopharma
– Sunshine Act
– Caronia Ruling (you knew I would have to get something in here about this)
– History of MSL Role
– MSL Facts of Interest
– Value of MSLs by Physicians
– Diagnostic MSLs
– CIA Driven Changes
Obviously, this is merely a few key concepts from the day but it should give you some flavor of the type of discussions and the focus of the meeting. Overall I would say the tone was very positive, given the challenges MSLs face in their highly regulated environment. Everyone at the meeting was confident that MSLs value was high and these challenges could be met. Look forward to tomorrow.
In previous posts this week I have broken down the key provisions of Sunshine Act rules. Now I want to provide my thoughts on what this means for MA leaders and their teams.
Owning the Correction Process
Everyone who conveys something of value to a physician within biopharma will need to understand these rules and their part of tracking them. This is a new administrative burden for many parts of biopharma.
BUT, there is one specific work activity that I want to address before I jump into implementation concerns. When all this data is compiled and sent to CMS, the physicians will have a yearly chance to review it and offer corrections. These corrections will need to be reviewed and discussed with the company.
So the big operational question is – Who is going to take point on that correction interaction? Are we going to expect that the physician try to contact different functional areas within the company directly with their questions? That may not be reasonable since the reported values will not make it clear who is responsible within the biropharma.
I am going to suggest that someone needs to take clear ownership of this responsibility and in the case of KOLs it should be MA. MA should be responsible for serving as the point of contact for KOLs with these issues and driving the issues to resolution. Non-KOL physicians should be handled by an administrative group in finance, but KOLs really need to handled carefully if we do not want to damage our relationships.
Overall Sunshine Implementation
To prepare for the Sunshine Act, MA needs to ensure the following:
I will highlight each of these elements and discuss related key Sunshine Act rules.
1. Internal Systems Developed for Sunshine Reporting
This is one area that MA probably has the least control. These should already be underway and hopefully MA has already had a fair amount of say. If MA is part of the stakeholder group that is reviewing these systems, I would ask the following questions based on my reading of the Sunshine Act rules:
2. MA Personnel Training on Sunshine Reporting
There is a fair amount of nuance in the Sunshine Act reporting rules. It is critical that training is developed that make the following clear to MA staff:
3. Educating Physicians and Especially KOLs
It is vital that our KOLs are aware of the rules so that we can avoid confusion and bad feelings. Some key elements of the rules that I believe every physician/KOL should know:
There are a lot of these so I will break this into a couple of posts and conclude by highlighting the ones I think are the most challenging to address.
I will analyze what this means for MA leaders and their team in a subsequent post. Please leave your comments below.
We have been discussing the Sunshine Act here on the MA Focus blog for awhile. The much delayed rules of have finally been released – all 282 pages! And, boy, are they exciting reading!
Biopharma is to begin collecting this data on August 1, 2013 with the first set of reports due to CMS on March 31, 2014. So, to the degree your teams will need to be educated on what to capture and how to report, there is actually very little time to set up the systems you need.
As a result, even if these rules are not exciting reading, they are important. I have reviewed them and identified some highlights that I think will be important to everyone in MA. I summarize the highlights below along with page references if you want to read all the riveting detail. There are a lot of these so I will break this into a couple of posts and conclude by highlighting the ones I think are the most challenging to address.
End of Part 1 – Only 177 Pages to Go!
At a recent CBI compliance conference in DC, Tom Abrams, director of the Office of Prescription Drug Promotion (OPDP) in the Center for Drug Evaluation and Research (CDER) basically said that as far as his agency was concerned nothing was going to change in their enforcement of off-label promotion. His rationale is, in my non-legal opinion, in the vein of “it depends on what the definition of ‘is’ is”. I think OPDP has chosen to see what they want to see in the ruling, but regardless they are not changing their approach or tactics.
Take a look at his full statement below:
The government has determined not to seek further review of the Second Circuit’s decision in United States v. Caronia, No. 09-5006-cr (2d Cir.). FDA does not believe that the Caronia decision will significantly affect the agency’s enforcement of the drug misbranding provisions of the Food, Drug, and Cosmetic Act (FD&C Act).
In 2009, Alfred Caronia was convicted of conspiring to distribute a misbranded drug in violation of the FD&C Act. A divided panel of the Second Circuit held that the jury instructions erroneously permitted, and that the government’s argument encouraged, the jury to treat speech promoting unapproved (off-label) uses of an FDA-approved drug as a criminal offense in and of itself. The court of appeals did not address the constitutionality of the theory of liability on which the government had defended the conviction: namely, that the promotion of a drug for an unapproved use may be relied on as evidence that the unapproved use is an intended one, and a drug that lacks adequate directions for its intended uses is misbranded.
Because the court did not address the constitutionality of a prosecution resting on that theory, and because the court also acknowledged that the First Amendment does not preclude an enforcement action based on speech regarding unapproved uses that is false or misleading, the Second Circuit’s decision does not bar the government from continuing to enforce the misbranding provisions of the FD&C Act, including through criminal prosecution where appropriate, in cases involving off-label promotion. More generally, the decision does not strike down any provision of the FD&C Act or its implementing regulations, nor does it find a conflict between the Act’s misbranding provisions and the First Amendment or call into question the validity of the Act’s drug approval framework.
Bottom line, they are sticking with the belief that while anyone has the “right” to promote off-label, doing so ultimately leads to misbranding which is in violation of the FD&C act. How you square this with the Second Circuit’s ruling that there is protection for promoting off-label as long as the information provided is true will be an argument that will, no doubt, end up back in court. I’m not a lawyer but I thought my rights trump your laws.
But for now off-label promotion remains open to OPDP enforcement.
What are your thoughts?
h/t PharmaExec Blog
In a ruling with huge potential impact on MA as well as commercial functions, the Court of Appeals for the Second Circuit in Manhattan has overturned a conviction of a salesperson who was promoting the off-label use of a product! This 2-1 ruling goes against years of court rulings stating that pharma does not have the right to promote off-label. In fact, in the past month GSK has been fined $3 billion for off-label promotion and J&J fined $181 million for off label promotion.
Clearly, new legal ground is being broken here. BUT, if urge caution. This is one ruling that contradicts years of previous rulings. It may serve as grounds for kicking this up to the Supreme Court, but until clear legal direction is given I would not be changing any policies.