Steps 1, 2, 3, 4 signpost.

The Ongoing Step Therapy Debate

By Laura Karas

Senator Lisa Murkowski’s (R-AK) reintroduction this February of a federal bill, the Safe Step Act, has revived the debate over the prudence of step therapy protocols.

Step therapy is an insurer utilization-management tool imposed in response to high drug prices. As its name implies, step therapy requires “steps” before a patient can receive his preferred medication (i.e., the one his provider has prescribed). Typically, a patient must “try and fail” a less costly medication or series of medications before becoming eligible for insurance coverage of the medication in question. In effect, step therapy allows an insurer’s “preferred therapy” to supersede patient and provider preference.

The need for step therapy is closely bound to the problem of high drug prices. But the crux of the step therapy debate boils down to the following: Who should decide which pharmaceutical drugs your health plan covers? You and your doctor, or your insurer?

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Drone hovering in air above mountain range.

Drone-Enabled Pharmaceutical Delivery: Navigating Regulatory Turbulence

By Vrushab Gowda

The burgeoning industry of drone-enabled pharmaceutical delivery offers a number of advantages over its low-tech forebears, not least including patient convenience.

It minimizes exposure to infection and potentially protects patient anonymity, all while reducing wait times relative to in-person or traditional mail-order pharmacies. Additionally, drones can broaden access to medications in resource-poor areas, including locations with low densities of health care facilities, and those where underdeveloped transportation links hinder ground delivery.

However, drone delivery of pharmaceuticals enters into a nebulous legal environment, sitting as it does at the intersection of healthcare, privacy law, and aviation regulation. It is, moreover, a dynamic landscape, which continues to evolve with new federal rules, judicial decisions, and corporate practices.

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gavel on top of a pile of bills and pills

Federal Court Halts Implementation of 340B Dispute Resolution Rule

By Sravya Chary

The U.S. District Court for the Southern District of Indiana’s recent decision to grant Eli Lilly’s motion for a preliminary injunction rightfully halted the implementation of a dispute resolution rule for the 340B Drug Pricing Program.

The Alternate Dispute Resolution Final Rule (“ADR Final Rule”), issued on December 10, 2020, attempted to settle oft-occurring battles between pharmaceutical manufacturers and 340B covered entities. A few weeks later, the Department of Health and Human Services (HHS) released a 340B advisory opinion defining the department’s understanding of the statute.

The 340B Drug Pricing Program was established by Congress in 1992 with the intent to stretch federal resources to serve the nation’s most vulnerable patients. In practice, however, the program has deviated from its original intent.

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Gavel surrounded by piles of money.

3 Challenges to Patents on Therapeutic Monoclonal Antibodies

By Gregory Curfman

Three new developments — two based on litigation and one based on a federal statute — may have significant effects on pharmaceutical manufacturers’ use of patents to fend off competition and maintain high prices for therapeutic monoclonal antibodies.

Highly specific monoclonal antibodies have played an increasingly important role as precision therapies for a growing number of diseases, including malignant, cardiovascular, and inflammatory conditions. As therapies derived from research and development, therapeutic monoclonal antibodies may be — and usually are — patented, providing manufacturers with protection from competition and the prospect of high revenues.

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Hundred dollar bills rolled up in a pill bottle

Ensuring 340B Discounts Trickle Down to Low-Income Patients

By Sravya Chary

The 340B prescription drug program was created with the original intent of providing discounted drugs to vulnerable patients. However, this program inadvertently created a revenue stream for for-profit retail pharmacies and intermediaries, which is cutting into the benefit received by low-income patients.

In a previous blog post, I discussed the pitfalls of a recent 340B advisory opinion released by the Department of Health and Human Services (HHS). The aim of this opinion was to provide more clarity regarding contract pharmacy use within the 340B program. However, the opinion ultimately did not alleviate the tension between pharmaceutical manufacturers and 340B representatives.

As one facet of a long-term solution to this ongoing issue, I proposed further investigation of 340B savings to analyze whether discounts are truly trickling down to vulnerable, low-income patients.

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Pill pack.

HHS’s 340B Advisory Opinion: Helpful or Harmful?

By Sravya Chary

A recent advisory opinion released by the Department of Health and Human Services (HHS) left many 340B advocates hungry for answers and pharmaceutical manufacturers frustrated.

The 340B program discounts the price of drugs paid by safety net hospitals to pharmaceutical manufacturers. The program is of critical importance to low-income and uninsured patients, especially during the COVID-19 pandemic.

HHS should take timely measures to resolve the concerns raised by the advisory opinion and resume the free flow of 340B discounted drugs to vulnerable patients.

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Map of United States made up of pills.

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet SarpatwariBeatrice Brown, Neeraj Patel, and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues.

Below are the citations for papers identified from the month of January. The selections feature topics ranging from an analysis of recent regulatory and legal developments in drug-pricing transparency, to an argument for the extent to which political actors should have influence over the FDA, to a descriptive analysis of state-level drug product selection laws. A full posting of abstracts/summaries of these articles may be found on our website.

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Photo of person with gloved hand holding flask at lab bench.

Pharmaceutical Patents on Manufacturing Methods: Groundless or Well-Supported?

By Laura Karas

Are manufacturing method patents — patents not on a pharmaceutical drug itself, but on a method of production of a drug — warranted intellectual property protections, or groundless obstacles to competition?

Patents protect and reward innovation by permitting the patent-holder the exclusive right to make, use, and sell the invention for a twenty-year period. Pharmaceutical companies have attracted scrutiny, criticism, and legal challenges for amassing large numbers of patents on pharmaceutical drugs, especially high-priced and high revenue-earning drugs.

Here I explore the topic of pharmaceutical patents on methods of production and translate into layman’s terms some thought-provoking recent scholarship by innovation scholars W. Nicholson Price and Arti Rai.

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close up photo of U.S. currency.

When “Pay-for-Delay” Becomes “Delay-Without-Pay”: Humira Antitrust Claims

By Laura Karas

In June 2020, the U.S. District Court for the Northern District of Illinois dismissed state and federal antitrust claims against AbbVie, maker of Humira (adalimumab), for accruing more than 130 patents on the top-selling drug and asserting allegedly unmeritorious patent infringement claims against makers of adalimumab biosimilars. AbbVie then settled the patent infringement litigation by entering into agreements with eight drug makers to allow adalimumab biosimilars to enter the U.S. market in 2023 and the European market in 2018.

In my last post, I discussed the district court’s memorandum opinion finding that “the vast majority” of AbbVie’s conduct was not “objectively baseless petitioning” and was therefore immunized under the Noerr-Pennington doctrine. In this post, I explore several problematic aspects of the court’s reasoning for rejecting the claims of pay-for-delay and market allocation.

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