PhRMA Launches $1M+ Ad Campaign Against 340B Drug Pricing Program; FDA Rejection Rates for Cell and Gene Therapies Surge

The middle of the week has arrived, and with it, a fresh round of pharmaceutical industry updates. Below, we’ve compiled the latest developments, including a major lobbying effort against a federal drug discount program and troubling trends in FDA approvals for advanced therapies.

PhRMA Unveils $1M+ Ad Blitz Against 340B Program

One of the most influential pharmaceutical lobbying groups in Washington, the Pharmaceutical Research and Manufacturers of America (PhRMA), is launching a seven-figure advertising campaign targeting the 340B Drug Pricing Program, Bloomberg Law reports. The campaign, set to begin on Wednesday, aims to highlight perceived abuses of the program, which requires drug manufacturers to provide discounted medications to eligible healthcare providers serving low-income and uninsured patients.

The 30-second ad features a fictional nonprofit hospital where administrators allegedly manipulate the 340B program to divert savings away from patients, instead using the funds for unrelated expenses.

What Is the 340B Program?

The 340B Drug Pricing Program is a federal initiative that mandates drug manufacturers to offer discounted prices on medications to healthcare organizations that treat a high volume of low-income and uninsured individuals. The program was established to improve access to affordable healthcare for vulnerable populations.

FDA Rejection Rates for Cell and Gene Therapies Spike Dramatically

Regulatory challenges are intensifying for the cell and gene therapy sector. According to data from the Alliance for Regenerative Medicine, cited by STAT, the U.S. Food and Drug Administration (FDA) rejected 18% of cell and gene therapy applications from 2020 to 2024. However, in the subsequent 15 months, the rejection rate surged to 38%.

These figures were highlighted at the Meeting on the Med conference in Rome last week, where industry experts expressed growing concern over regulatory instability. The FDA’s division responsible for reviewing cell and gene therapies has seen increased rejections and reversals of prior decisions, undermining the sector’s previously stable regulatory framework.

Companies had come to rely on a predictable and collaborative regulatory process, but recent turmoil has shaken confidence. Industry stakeholders are also worried about broader issues at the FDA, including understaffing across multiple offices, as discussed in other panels at the conference.

For further insights, STAT+ subscribers can read the full report.