InsideSources

When the FDA Moves the Goalposts, Children with Rare Diseases Lose by Jessica Haywood.

"For families with children who have Sanfilippo syndrome, a terminal type of childhood dementia, time is not measured in years or presidential cycles. It is measured in lost words, hospital visits, seizures and skills slipping away. Birthdays are bittersweet because we know there will be far too few of them.

"This community is not alone. Children suffering from thousands of rare and debilitating childhood diseases, such as Hunter syndrome, Duchenne muscular dystrophy, and many others, are declining every day.

"However, they don’t have to. The Food and Drug Administration can move today to prioritize therapies that have made a measurable difference for these children, such as the Sanfilippo type A gene therapy UX111, which has been helping patients for almost 10 years.

"My niece, Sadie, is almost 10 years old and is full of life despite her struggles with Sanfilippo syndrome. Sadie was diagnosed early, at only 3 months old. Around the same time, the first child was dosed with UX111. We have been watching this drug’s development for Sadie’s entire life. We have longed for it to reach approval so she could receive it.

"Unfortunately, the application has been delayed twice due to manufacturing documentation, not safety or efficacy concerns. For diseases with a life expectancy of 15 years, accelerated approval and regulatory flexibility must operate as intended.

"We’ve spoken to parents of children who have been treated with UX111 at varying ages. Their kids are running when they should be wheelchair bound. They’re eating by mouth when otherwise they should have a feeding tube. After seeing such promise, the FDA’s rejection last summer was devastating. And we weren’t alone, as many rare degenerative disease patients watched approvals for diseases like Duchenne and Spinocerebellar ataxia slow or come to a screeching regulatory halt. ..."

When the FDA Moves the Goalposts, Children with Rare Diseases Lose – DC Journal - InsideSources For families with children who have Sanfilippo syndrome, a terminal type of childhood dementia, time is not measured in years or presidential cycles. It

From Truman to Trump: How Licensing Replaced Unions as Labor’s Gatekeeper by Morris M. Kleiner.

"Ask a room of labor economics students or politicians which two U.S. presidents were union members and subject to occupational licensing, and most will hesitate.

"The answers — Harry Truman and Donald Trump — bookend a profound shift in how entry into the workforce is controlled in America. That shift is among the reasons Trump now grapples with the fallout of everyday services becoming costlier and harder to access.

"Truman was a dues-paying member of the railroad workers’ union and worked in jobs that today require a license: as a pharmacy assistant and as a municipal judge. Trump joined the Screen Actors Guild through his television work and earlier held a real estate broker’s license in New York.

"During Truman’s era, as most people know, unions were the dominant force in the labor market. Manufacturing accounted for more than one-third of U.S. employment in the mid‑1950s, and the National Labor Relations Act had recently strengthened collective bargaining. Wages, access to jobs, and workplace rules were negotiated between labor and management, with federal law attempting to balance power on both sides.

"Before and during Trump’s time in unions, things changed. As manufacturing famously declined and the economy shifted toward services, the regulatory center of gravity shifted with it. Today, 70 percent of Americans work in service-sector jobs — from accountants to estheticians — while private-industry unionization has fallen to 6 percent and overall unionization stands at 10 percent.

"Occupational licensing became the labor market’s new gatekeeper, surging from 5 percent of workers in Truman’s time to nearly 25 percent today. This quiet revolution has reshaped the labor market far more than most Americans realize.

"Unlike unions, which operate at the workplace level, licensing is imposed by state governments and enforced by their licensing boards. In many cases, these boards wield powers that exceed those of unions, backed by the state’s legal and policing infrastructure. ..."

From Truman to Trump: How Licensing Replaced Unions as Labor’s Gatekeeper – DC Journal - InsideSources Ask a room of labor economics students or politicians which two U.S. presidents were union members and subject to occupational licensing, and most will