Welcome to the Week in Review.

P4AD Releases New Video on The ETHIC Act

Patients For Affordable Drugs Now released a new video featuring patient advocates and staff highlighting the bipartisan ETHIC Act ahead of this week’s House Judiciary hearing on patent law and prescription drug access. Introduced by Sens. Peter Welch, Josh Hawley, and Amy Klobuchar, the bipartisan ETHIC Act would make it easier for generic manufacturers to challenge duplicative patents — lowering barriers to entry and helping drive down costs for patients as well as taxpayers. The bill is gaining traction as lawmakers increasingly focus on how patent thickets delay competition. To date, P4ADNow has mobilized nearly 16,000 patient advocates to contact Congress in support of ETHIC and submitted written testimony to a House Judiciary Subcommittee hearing on ETHIC Thursday. AARP and the ERISA Industry Committee also joined P4ADNow in a joint letter to Congressional leadership urging action. — [P4AD, Testimony, Joint Letter]

SCOTUS Protects Generic Competition

The Supreme Court unanimously ruled in favor of generic drugmaker Hikma Pharmaceuticals, preserving a critical pathway that allows lower-cost alternatives to come to market. The case focused on “skinny labeling,” which lets generics launch for unpatented uses, without waiting for every patent on a drug to expire. Had the court ruled the other way, generic manufacturers could have faced increased legal risk when following the rules established by Congress and the FDA — meaning delayed competition, and higher drug prices for patients and taxpayers. Competition is one of the most effective mechanisms for lowering prescription drug prices. — [SCOTUS, Fierce Pharma, IP Watchdog, POLITICO, STAT News, Endpoints News]

New TrumpRx Drugs Don’t Fix Existing Problems

Despite the Trump administration billing the 160 new medications coming to TrumpRx as new deals, these — like last month’s announcement of 600 generic drugs — are instead simply links to existing cash-discount programs already available to patients. While TrumpRx may help some patients navigate existing options, it does not address the underlying drivers of high costs — including the structural conditions that allow drug companies to price-gouge Americans for their essential medicines. — [Washington Times]

ICYMI: The FDA released new draft guidance allowing developers to leverage existing scientific and manufacturing knowledge (from past studies, similar therapies, or their own previous work) to streamline the development of cell and gene therapies. The move is part of a broader effort to reduce regulatory friction and speed approvals of these complex treatments. While faster development can improve access, it does not necessarily translate to lower prices, particularly with therapies that already launch at extremely high costs, such as a treatment for sickle cell disease that costs $2.2 million per patient. — [Endpoints News, Axios]

Patient Advocate Spotlight

Name: Mary Schmidt

Condition: Pityriasis Rubra Pilaris (PRP)
Drugs: Prescribed Otezla ($3,000 / month) but is unable to afford the cost
Background: Patient Advocate from Devine, Texas

In Her Words: “When I was first prescribed Otezla, it worked very well. In an attempt to continue the medication,  I applied to the drugmaker’s assistance program because I knew it was very expensive. I attempted to prove to them that I was on a limited income. I even had to apply for Extra Help via Texas’s Health and Human Services which sent me a letter saying I could get $1,600 of additional coverage, but that would still be way too expensive. 

As a result, I had to go on Methotrexate — a drug that has the potential to do more harm than good for me. I had to have my blood drawn regularly and would bruise badly because of my condition. Next, I was put on Skyrizi and was accepted into their assistance program for a year — but it then came time to renew, and I haven’t been able to get back into the program again. 

This has been an ongoing issue, and I’ve done everything possible on my part. In the meantime, I’m forced to call my dermatologist and ask if they have a sample, simply to get my next dose. Otezla and Skyrizi cost thousands of dollars that I do not have. Medication for profit is really sad and life-threatening to patients like me.”

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