Category Archives: Generic Drug Supply

Drug shortages reach all-time high

Posted on by • Posted in Drug Shortages, Generic Drug Supply, Generic Drugs, Medicare, Medicare Payment, Obesity Treatment, Pharmaceutical Industry • Leave a comment

https://www.axios.com/2024/04/11/drug-shortage-record-high

With 323 medicines in short supply, U.S. drug shortages have risen to their highest level since the American Society of Health-System Pharmacists began tracking in 2001.

Why it matters: 

This high-water mark should energize efforts in Congress and federal agencies to address the broken market around what are often critical generic drugs, the organization says.

  • The Biden administration last week issued a drug-shortage plan that called on Congress to pass legislation that would reward hospitals for maintaining an adequate supply of key drugs, among other measures.
  • As a “first step,” Medicare yesterday proposed incentives for roughly 500 small hospitals to establish and maintain a six-month buffer stock of essential medicines.

The big picture: 

Many of the issues behind shortages are tied to low prices for generics that leave manufacturers competing on price.

  • “It’s been a race to the bottom. We need more transparency around quality so that buyers have a reason to not chase the lowest price,” said Michael Ganio, senior director at the ASHP.
  • Drugmakers that can demonstrate safer, higher-quality manufacturing practices should earn a higher price, he said.
  • Manufacturing quality concerns in particular have fueled shortages of chemotherapy drugs and some antibiotics.

Between the lines: Other factors are also driving drug shortages.

  • Controlled substances, such as pain and sedation medications, account for 12% of active shortages, which are tied to recent legal settlements and Drug Enforcement Administration changes to production limits, per ASHP.
  • Not surprisingly, the blockbuster category of anti-obesity drugs known as GLP-1s are in shortage largely because of outsized demand.
  • That’s also the case for ADHD drugs and hormone therapies used in gender-affirming care.

Why the Pentagon is concerned about our generic drug supply

Posted on by • Posted in Dept of Defense (DOD), Food and Drug Administration (FDA), Generic Drug Supply, Generic Drugs, Pharmaceutical Industry, Quality, Quality Control, Quality Testing • Leave a comment

https://mailchi.mp/a93cd0b56a21/the-weekly-gist-june-9-2023?e=d1e747d2d8

Published this week in Bloomberg, this article explores the Department of Defense (DOD)’s rationale for reportedly piloting a partnership with Valisure, an independent laboratory, to test the quality of the generic drugs it purchases for military members, veterans, and their families. 

The DOD’s current plan is to follow the example of Kaiser Permanente, which contracted with the same drug testing company to ensure quality standards for generic drugs that exceed Food and Drug Administration (FDA) requirements. While the FDA has discouraged the use of third-party testing programs, recent stories of toothless enforcement for troubled manufacturing facilities have weakened the agency’s credibility.

The Gist: Amid the current backdrop of drug shortages and cost concerns, this article shines a light on the lesser-known issue of quality oversight of generic drugs. This is especially important as generic medications make up around 90 percent of all prescriptions dispensed in the US. 

With generic drug production, largely a low-margin business, moving overseas, the FDA has increasingly struggled to perform oversight and quality control—though Valisure’s scientific methods have been criticized both in court and by the FDA itself. 

While Pentagon officials have labeled the vulnerabilities in our drug supply chain a threat to national security, the problems the DOD is hoping to resolve are the same ones faced by all purchasers of generic drugs in the US.