PRC Review: 2019 Recap

  [smart_track_player url="https://media.blubrry.com/darshantalks/content.blubrry.com/darshantalks/ep167_recap_of_prc_review_mixdown.mp3" title="PRC Review: 2019 Recap" color="#FF5722" social_linkedin="true" social_email="true" tweet_text="Listen to this @darshantalks podcast on #PRC Review: 2019 Recap!"] February 20, 2020 Darshan: Hey everyone. Welcome to another episode of DarshanTalks. We have a really, really exciting conversation for you. Today what we're going to talk about, is the idea of PRC review or Promotional Regulatory Committee review, which sometimes is also called the MLR or the LMR, which is the Legal Medical Regulatory review. The Kulkarni Law firm provides services reviewing these types of promotional pieces. So what are some issues that have popped up in 2019 that are different, or worth mentioning as you go into 2020? Narrator: This is the DarshanTalks Podcast, Regulatory Guy, Irregular Podcast, with host Darshan Kulkarni. You can find the show on Twitter @DarshanTalks, or the show's website at darshantalks.com Darshan: The number one issue, lay summaries. If you are engaged in any type of clinical research, the EMA has put out certain requirements saying that you need to put up plain language summaries, so that patients can understand this information. However, that's more for the EMA. The moment you do that in the US, that would be considered potentially promotional. Is that information being... And a lot of companies are saying, "You know what? What do we want to do is we want to have a global standard that reviews these pieces." So plain language summaries. Are they being reviewed in your company? What rules are they being reviewed as? Scientific discussion may not be subject to PRC review. On the other hand, medical stuff, doesn't necessarily always go through PRC review. However, if it's patient-facing, maybe it does. What are your rules around this information? Darshan: Number two, patient groups. Everyone's been talking about using patient groups and patient advocacy, and that's great. However, there have been several instances where patient groups are getting prosecuted. It's often because these patient groups, end up being four methods in which copays for these companies, copays towards these products, are being paid for. Copays are used as a system by the government to ensure that moneys are appropriately being used towards the cost of drugs. However, these patient advocacy groups often come out and pay the copay, and the result of that is, allegedly, that drugs are being inappropriately prescribed. At least three different companies have agreed to pay a total of $122.6 million to resolve claims that they violated the False Claims Act by illegally paying the Medicare or Civilian Health and Medical Program copays for their own products. And, Jazz and Lundbeck each entered five-year corporate integrity agreements with the OIG as part of the respect of settlements. So, stay tuned. Just because it's a patient group doesn't mean you're home free. You need to make sure it's being reviewed appropriately. Darshan: Then the next question we'll look at is social media. And when we talk about social media, we're really talking about the Amarin vs... The Amarin case. And essentially what had was, Amarin accused DSM Pharmavite and Nordic Naturals of importing dietary supplements, and making claims. And essentially, their argument was that these are new drugs that have not received approval from the FDA. They went to the ITC and they said that you need to launch an investigation, because the FDCA, the Food, Drug, and Cosmetics Act, bars private enforcement, the ITC tossed the claim in 2017. The Federal Circuit held that the ITC can refuse to probe allegations. So, Amarin's claims are based on alleged violation of the Fo...