Peters & Peters’ Post

Things I LOVE about #PhRMA‘s Challenge to Mississippi‘s #ContractPharmacy Law There’s a lot to love in PhRMA’s lawsuit against MS’ law, which is described in Nyah Phengsitthy’s great article: 1) Getting Another Circuit Involved: With the 8th Circuit having upheld the Arkansas #340B statute, the big picture strategy is to get as many cases as possible filed in OTHER circuits. PhRMA is searching for at least one court of appeal to disagree with the 8th, so that Supreme Court review becomes much more likely. This Mississippi case is ultimately headed to the 5th Circuit Court of Appeal—a step forward for PhRMA in executing on its strategy. 2) Hits the Santa Clara Case Hard: The complaint does a great job of arguing that the Supreme Court’s decision denying #coveredentities the ability to sue manus must also prevent Mississippi from interfering with #HRSA’s enforcement of the 340B program. The complaint pounds away at the fact that, to find a violation of the state law, MS would have to determine a bunch of federal questions: whether the CE is an eligible entity, whether diversion occurred, whether a duplicate discount exists, etc. As the complaint argues, MS therefore “cannot enforce” its law “without rendering decisions on … federal issues”. The resulting risk of a conflict in federal and state determinations of those questions would “directly contradict[] the Supreme Court’s reasoning” in Santa Clara. There, the Supremes wanted no 340B litigation that wasn’t brought by #HHS for fear the government’s control of the program might be thereby compromised. Similarly, the complaint pounds away at how state enforcement would necessarily be different than and more punitive than #HRSA’s, where MS includes potential criminal charges, for example. It also stresses how HRSA itself has said its ADR mechanism is supposed to be “binding” on any claim that a manu has “limited” CE “access”. Congress, the complaint concludes, quoting the SCt, “vest[ed] authority to oversee compliance with the 340B program in #HHS”—and HHS alone. 3) Goes Right After the 8th’s False Premises: The 8th Circuit got to its result by falsely assuming that CPs don’t take title and act as “agents” of CEs. The complaint directly disputes that, and it argues that the MS law, contrary to HRSA’s guidance, compels sales at the 340B price even where the CE doesn’t retain title and the CP isn’t an agent. 4) “Price” vs “Delivery”: The 8th dubiously held that the Arksnsas law didn’t conflict with the 340B statute because 340B is supposedly only about “pricing” and the state law is purportedly only about “delivery”. The MS complaint swats that aside: MS and others “have tried to rationalize” that the MS law is “simply a drug ‘delivery’ regulation,…there is no dispute” that MS #pharmacies “can already…receive delivery…at market prices. The only question is whether…340B price applies”. See reasons 5 and 6 to love the complaint in the comment below. #lifescienses

Now that the initial dust of the Loper Bright decision has settled, companies are left with to figure out how the decision impacts them and their industry. In the below law flash, my colleagues and I discuss all of the ways Loper Bright and the overruling of Chevron may impact the life sciences industry, with analyses of everything from FDA and healthcare and reimbursement, to IP, government contracting, litigation, public disclosures, and corporate business transactions (to name a few areas). #mllifesci #wearemorganlewis #drugs #lifesciences #pharmaceuticals #pharma #chevron #supremecourt

The U.S. Food and Drug Administration (FDA) published a revision of its final guidance on “Application User Fees for Combination Products,” replacing guidance of the same name from 2005. The revision modernizes the guidance to align it with current user fee program expectations. While acknowledging that two applications submitted for a cross-labeled combination product each require their own user fee, FDA spotlights in its revised guidance the various waivers, reductions, and exceptions available for application user fees, for both drug-led and device-led combination products. We have summarized those exemptions below, emphasizing FDA’s “barrier to innovation” waiver.

Lets take a peek behind the OIG Limiting Pharmaceutical Manufacturers’ Ability to Offer Drug Cost-Sharing Subsidies under a proposed arrangement where a group of oncology drug manufacturers would fund cost-sharing subsidies for the drugs they manufactured, additional programs, and Medicare Part D beneficiaries’ insurance premiums, among other things. While noting the importance of Medicare Part D beneficiary access to potentially life-saving medication, the HHS-OIG and courts ultimately concluded the proposed arrangement would violate the Anti-Kickback Statute (AKS), and the HHS-OIG could impose sanctions if the arrangement was undertaken and the requisite intent were present. #healthcarecompliance #healthcarecosts #healthcaresubsidies #healthcaredrugcosts #drugpricing #drugsubsidies #pharmaceuticalindustry #pharmacybenefits #pharmaceuticalindustry https://lnkd.in/gxEGwird

The U.S. Food and Drug Administration (FDA) published a revision of its final guidance on “Application User Fees for Combination Products,” replacing guidance of the same name from 2005. The revision modernizes the guidance to align it with current user fee program expectations. While acknowledging that two applications submitted for a cross-labeled combination product each require their own user fee, FDA spotlights in its revised guidance the various waivers, reductions, and exceptions available for application user fees, for both drug-led and device-led combination products. We have summarized those exemptions below, emphasizing FDA’s “barrier to innovation” waiver.

The U.S. Food and Drug Administration (FDA) published a revision of its final guidance on “Application User Fees for Combination Products,” replacing guidance of the same name from 2005. The revision modernizes the guidance to align it with current user fee program expectations. While acknowledging that two applications submitted for a cross-labeled combination product each require their own user fee, FDA spotlights in its revised guidance the various waivers, reductions, and exceptions available for application user fees, for both drug-led and device-led combination products. We have summarized those exemptions below, emphasizing FDA’s “barrier to innovation” waiver.

The U.S. Food and Drug Administration (FDA) published a revision of its final guidance on “Application User Fees for Combination Products,” replacing guidance of the same name from 2005. The revision modernizes the guidance to align it with current user fee program expectations. While acknowledging that two applications submitted for a cross-labeled combination product each require their own user fee, FDA spotlights in its revised guidance the various waivers, reductions, and exceptions available for application user fees, for both drug-led and device-led combination products. We have summarized those exemptions below, emphasizing FDA’s “barrier to innovation” waiver.

The U.S. Food and Drug Administration (FDA) published a revision of its final guidance on “Application User Fees for Combination Products,” replacing guidance of the same name from 2005. The revision modernizes the guidance to align it with current user fee program expectations. While acknowledging that two applications submitted for a cross-labeled combination product each require their own user fee, FDA spotlights in its revised guidance the various waivers, reductions, and exceptions available for application user fees, for both drug-led and device-led combination products. We have summarized those exemptions below, emphasizing FDA’s “barrier to innovation” waiver.

The U.S. Food and Drug Administration (FDA) published a revision of its final guidance on “Application User Fees for Combination Products,” replacing guidance of the same name from 2005. The revision modernizes the guidance to align it with current user fee program expectations. While acknowledging that two applications submitted for a cross-labeled combination product each require their own user fee, FDA spotlights in its revised guidance the various waivers, reductions, and exceptions available for application user fees, for both drug-led and device-led combination products. We have summarized those exemptions below, emphasizing FDA’s “barrier to innovation” waiver.

The U.S. Food and Drug Administration (FDA) published a revision of its final guidance on “Application User Fees for Combination Products,” replacing guidance of the same name from 2005. The revision modernizes the guidance to align it with current user fee program expectations. While acknowledging that two applications submitted for a cross-labeled combination product each require their own user fee, FDA spotlights in its revised guidance the various waivers, reductions, and exceptions available for application user fees, for both drug-led and device-led combination products. We have summarized those exemptions below, emphasizing FDA’s “barrier to innovation” waiver.