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The Readout Damian Garde & Meghana Keshavan

The trouble with Pfizer's vaccine boxes

Pfizer’s choice of packaging for its Covid-19 vaccine helps explain the obstacles and delays in its rollout, STAT’s Olivia Goldhill and Rachel Cohrs report. The insulated box, tightly packed with dry ice and about double the size of a carry-on suitcase, contributed to a spate of public health setbacks — but greater profits for the pharma behemoth. 

Pfizer decided that it wanted to ship the vaccine in large quantities — 1,170 doses at a time. These huge deliveries limited exactly who could receive the vaccine — complicating how it was disseminated everywhere, but increasing the amount of money the company could make per shipment.

“The size of the box was 100% a decision made by Pfizer, and it was not what we wanted,” one former HHS official told STAT. “We would have much preferred containers that held 100 doses rather than 1,000, but Pfizer did not want to discuss it with us.” 

Read more.

What does “one-and-done” treatment actually mean?

Do we really need a permanent FDA commissioner? And what’s Scott Gottlieb’s grilling technique? 

We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. First, STAT's Andrew Joseph joins us to talk about the two-year anniversary of the approval of gene therapy Zolgensma and the effect it has had on families dealing with the rare disease spinal muscular atrophy. Then, former FDA Commissioner Scott Gottlieb calls in with tips on Memorial Day grilling, notes on a recent Twitter spat, and thoughts on the origins of SARS-CoV-2.

Listen here.

Lilly being examined by the DOJ

The U.S. Justice Department is probing Eli Lilly following claims there were manufacturing irregularities and tampering with records at a New Jersey factory, Reuters reports. The level of governmental scrutiny on the pharma giant is increasing: Lilly has been under a microscope for more than a year for lapses at this particular site. 

In March, Reuters reported that a Lilly human resources officer had been allegedly forced out of her job at the New Jersey plant after delving deeper into employee complaints about manufacturing lapses, falsified or destroyed records, and staff shortages. The Branchburg factory produces the company’s Covid-19 therapy and other drugs. 

FDA reverses HHS decision on grandfathered drugs

Many drugs were grandfathered into the market, but never actually achieved FDA approval. So back in 2006, the Unapproved Drugs Initiative forced drug makers to send their decades-old products through the regulatory pipeline — a polarizing program that was put to an end just last year by the Trump administration. The Department of Health and Human Services said that although the program had “laudable goals,” it yielded “very limited benefits” and that ending it would ultimately save billions of dollars. 

Now, the FDA is reversing this decision — taking HHS to task in a dense legal document, STAT’s Ed Silverman writes. Although the program has historically prompted complaints that it’s helped companies establish monopolies and hike drug prices, the FDA claims that HHS’s announcement last year “contained multiple legal and factual inaccuracies.”

Read more.

More reads

  • Inequities in cancer genomics undercut promise of precision medicine. (STAT)
  • FDA approves new imaging tool to find advanced prostate cancer. (NBC News)
  • Karuna investor settles charge of insider trading. (FierceBiotech)

Thanks for reading! More next week,

Damian

Friday, May 28, 2021

STAT

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