Thoughts on Global Medical Affairs
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