21st Century Cures Act Tracker
I found this handy legislative tracker, so I'm adding it to the blog, so you can bookmark this post to stay updated on this legislation. Currently, it's in the Senate and has been assigned to a committee.
The Amarin Injunction
On August 7, 2015, a federal district judge issued a preliminary injunction prohibiting the FDA from taking action to prevent Amarin Pharma from disseminating off-label information about Vascepa for the treatment of patients receiving statins who also had persistently high levels of triglycerides. This action has been widely hailed as a significant blow to FDA's authority to regulate off-label promotion and also as a major victory for defenders of the first amendment rights of pharmaceutical companies, and while I've seen and read many blogs and news stories dissecting the ruling for attorneys (I recommend this and this from FDAlawBlog), I haven't seen anyone discuss how this affects FDA regulatory professionals. That's what this blog entry is intended to address.
For this post, I feel the need to reiterate that I'm not an attorney, and nothing you read on this blog should be construed as legal counsel.
In this case, Amarin followed the SPA and met the primary endpoints, but the FDA decided that research conducted in the interim had cast doubt on whether the endpoints were meaningful, so FDA convened an advisory board, which voted against approval, and then FDA issued a complete response letter to Amarin denying the approval. FDA stated in its complete response letter that Amarin should NOT promote Vascepa for the expanded indication.
Amarin filed suit against FDA stating that FDA was attempting to preemptively prevent Amarin from disseminating truthful, non-misleading information about its products.
In response to this suit, FDA sent a letter to Amarin (and the court) stating that FDA did not object to any of the information that Amarin intended to disseminate, so long as Amarin made certain disclosures about that information.
That takes us to the preliminary injunction.
Key takeaways from the Amarin ruling:
1. Dissemination of off-label reprints is uncontested.
Though previous FDA guidance on this topic would seem to have firmly enabled this practice, there nonetheless have been holdouts and suspicion about its provenance. This ruling further enhances the confidence companies can have in the permissibility of disseminating these reprints.
2. Disclosures are crucial.
One key component of the injunction that was ignored by many is that Amarin wanted to omit information about FDA having declined to grant approval for the use being studied. The judge disagreed with Amarin, and though he didn't entirely accept FDA's proposed wording of the disclosure, he did agree that Amarin needed to provide the information that not only was the use not currently approved, the FDA declined to approve that indication.
3. There's more to come.
The judge issued this ruling on August 7 granting Amarin the preliminary injunction it sought. The preliminary injunction was a sign that the judge thought Amarin was likely to succeed based on the merits of the case, but it was not itself a final decision; and it appears unlikely that such a decision will be reached because on August 28, Amarin and the FDA requested that the judge hold off on ruling on the underlying case because the two parties were working out a settlement. The nature of that settlement might provide greater clarity, if it is publicly released.
4. The status quo is unchanged.
As much as the ruling itself was heralded in many circles as a significant blow to FDA's authority to prohibit off-label promotion, at the end of the day nothing has changed. FDA had already stated that it would not have objected to Amarin's dissemination of the information if certain disclosures were provided. So, the injunction ruling prevents FDA from taking an action that FDA had already said it didn't intend to take.
This wasn't so much a landmark ruling against FDA as it was tweaking around the edges of how to follow FDA's off-label reprint guidance, but the specifics of the case are highly relevant. Unless your company happens to be in the 2nd circuit and to have entered into a Special Protocol Assessment with FDA and to have had the specific indication rejected by FDA, it will be very difficult to apply the principles of this ruling to your situation (such as how to modify your disclosures outside of FDA's guidance on the matter). And in the meantime, companies should feel quite comfortable disseminating off-label reprints in accordance with FDA's previously issued guidance while avoiding off-label promotion itself.
For this post, I feel the need to reiterate that I'm not an attorney, and nothing you read on this blog should be construed as legal counsel.
Background
Amarin's Vascepa is currently approved by FDA as a drug indicated along with diet to lower triglyceride levels. Amarin sought expanded approval for patients who were taking statins and continued to have higher cholesterol levels. To gain this approval, Amarin entered into a Special Protocol Assessment (SPA) with FDA, where FDA sets out and agrees to a specific study design, endpoints, etc. Generally, if companies abide by the SPA and the study meets its primary endpoints, approval is a foregone conclusion.In this case, Amarin followed the SPA and met the primary endpoints, but the FDA decided that research conducted in the interim had cast doubt on whether the endpoints were meaningful, so FDA convened an advisory board, which voted against approval, and then FDA issued a complete response letter to Amarin denying the approval. FDA stated in its complete response letter that Amarin should NOT promote Vascepa for the expanded indication.
Amarin filed suit against FDA stating that FDA was attempting to preemptively prevent Amarin from disseminating truthful, non-misleading information about its products.
In response to this suit, FDA sent a letter to Amarin (and the court) stating that FDA did not object to any of the information that Amarin intended to disseminate, so long as Amarin made certain disclosures about that information.
That takes us to the preliminary injunction.
Key takeaways from the Amarin ruling:
1. Dissemination of off-label reprints is uncontested.
Though previous FDA guidance on this topic would seem to have firmly enabled this practice, there nonetheless have been holdouts and suspicion about its provenance. This ruling further enhances the confidence companies can have in the permissibility of disseminating these reprints.
2. Disclosures are crucial.
One key component of the injunction that was ignored by many is that Amarin wanted to omit information about FDA having declined to grant approval for the use being studied. The judge disagreed with Amarin, and though he didn't entirely accept FDA's proposed wording of the disclosure, he did agree that Amarin needed to provide the information that not only was the use not currently approved, the FDA declined to approve that indication.
3. There's more to come.
The judge issued this ruling on August 7 granting Amarin the preliminary injunction it sought. The preliminary injunction was a sign that the judge thought Amarin was likely to succeed based on the merits of the case, but it was not itself a final decision; and it appears unlikely that such a decision will be reached because on August 28, Amarin and the FDA requested that the judge hold off on ruling on the underlying case because the two parties were working out a settlement. The nature of that settlement might provide greater clarity, if it is publicly released.
4. The status quo is unchanged.
As much as the ruling itself was heralded in many circles as a significant blow to FDA's authority to prohibit off-label promotion, at the end of the day nothing has changed. FDA had already stated that it would not have objected to Amarin's dissemination of the information if certain disclosures were provided. So, the injunction ruling prevents FDA from taking an action that FDA had already said it didn't intend to take.
This wasn't so much a landmark ruling against FDA as it was tweaking around the edges of how to follow FDA's off-label reprint guidance, but the specifics of the case are highly relevant. Unless your company happens to be in the 2nd circuit and to have entered into a Special Protocol Assessment with FDA and to have had the specific indication rejected by FDA, it will be very difficult to apply the principles of this ruling to your situation (such as how to modify your disclosures outside of FDA's guidance on the matter). And in the meantime, companies should feel quite comfortable disseminating off-label reprints in accordance with FDA's previously issued guidance while avoiding off-label promotion itself.
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