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Drugmakers Cut Backroom Deals With FDA To Speed Up

Exclusive report reveals Eli Lilly and Regeneron part of a secretive FDA fast-track club, raising questions about preferential treatment in drug…

Drugmakers Cut Backroom Deals With FDA To Speed Up
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Exclusive! In a move that has insiders whispering about ‘preferential treatment,’ the Food and Drug Administration has tapped a cabal of pharmaceutical giants—including the world’s most valuable healthcare company—for a secretive new ‘fast-track’ club. Dubbed the ‘PreCheck’ pilot, this hush-hush initiative grants Eli Lilly, Regeneron, and a handful of other select players a golden ticket: the ability to cozy up with regulators while their new manufacturing plants are still under construction. The FDA claims it could shave a staggering 14 months off review times, but critics are already crying foul, questioning just how ‘domestic production priorities’ are being decided in this exclusive backroom.

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The program, reportedly a pet project of the current administration, is shrouded in corporate-speak about ‘addressing market supply gaps.’ But let’s read between the lines. The chosen few aren’t just making aspirin; they’re handling the complex, big-money biologics and gene therapies of tomorrow. Eli Lilly’s facility in Lebanon, Indiana, is poised to churn out the main ingredients for its blockbuster GLP-1 weight-loss pills and shots—products already drowning in demand and minting billions. A spokesperson for Lilly offered a cagey, non-committal statement about ’evaluating’ the program’s impact, a classic corporate maneuver that screams there’s more to this story.

Meanwhile, Regeneron’s CEO Leonard Schleifer couldn’t be happier, releasing a glowing statement praising the FDA’s ‘collaboration.’ His company’s $2 billion site in Saratoga Springs was also selected, further cementing the incestuous ties between top-tier innovators and their government overseers. The plot thickens with Fujifilm Biotechnologies, a contract manufacturer already pumping out antibodies for—you guessed it—Regeneron and Johnson & Johnson from its new North Carolina site. It’s a small, incestuous world at the top of the biopharma food chain.

What does this ’expedited process’ really mean? It’s a two-part love affair: ‘facility readiness,’ where the FDA gives private technical guidance behind closed doors, and ‘application submission,’ promising ‘hands-on feedback’ and sped-up inspections. Fujifilm is already boasting that it expects its ‘operational readiness review’ before year’s end thanks to this VIP lane. The implication is clear: if you’re not in the club, you’re stuck in the slow lane, watching the anointed ones race their next-generation drugs to market. This isn’t just business; it’s a scandal of access, where the rules are rewritten for a privileged few while the rest of the industry is left wondering who’s really calling the shots between Washington and Wall Street.

Original article: CNBC ▸

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business · Exclusive

Drugmakers Cut Backroom Deals With FDA To Speed Up

Exclusive report reveals Eli Lilly and Regeneron part of a secretive FDA fast-track club, raising questions about preferential treatment in drug…

Drugmakers Cut Backroom Deals With FDA To Speed Up

Exclusive! In a move that has insiders whispering about ‘preferential treatment,’ the Food and Drug Administration has tapped a cabal of pharmaceutical giants—including the world’s most valuable healthcare company—for a secretive new ‘fast-track’ club. Dubbed the ‘PreCheck’ pilot, this hush-hush initiative grants Eli Lilly, Regeneron, and a handful of other select players a golden ticket: the ability to cozy up with regulators while their new manufacturing plants are still under construction. The FDA claims it could shave a staggering 14 months off review times, but critics are already crying foul, questioning just how ‘domestic production priorities’ are being decided in this exclusive backroom.

Advertisement

The program, reportedly a pet project of the current administration, is shrouded in corporate-speak about ‘addressing market supply gaps.’ But let’s read between the lines. The chosen few aren’t just making aspirin; they’re handling the complex, big-money biologics and gene therapies of tomorrow. Eli Lilly’s facility in Lebanon, Indiana, is poised to churn out the main ingredients for its blockbuster GLP-1 weight-loss pills and shots—products already drowning in demand and minting billions. A spokesperson for Lilly offered a cagey, non-committal statement about ’evaluating’ the program’s impact, a classic corporate maneuver that screams there’s more to this story.

Meanwhile, Regeneron’s CEO Leonard Schleifer couldn’t be happier, releasing a glowing statement praising the FDA’s ‘collaboration.’ His company’s $2 billion site in Saratoga Springs was also selected, further cementing the incestuous ties between top-tier innovators and their government overseers. The plot thickens with Fujifilm Biotechnologies, a contract manufacturer already pumping out antibodies for—you guessed it—Regeneron and Johnson & Johnson from its new North Carolina site. It’s a small, incestuous world at the top of the biopharma food chain.

What does this ’expedited process’ really mean? It’s a two-part love affair: ‘facility readiness,’ where the FDA gives private technical guidance behind closed doors, and ‘application submission,’ promising ‘hands-on feedback’ and sped-up inspections. Fujifilm is already boasting that it expects its ‘operational readiness review’ before year’s end thanks to this VIP lane. The implication is clear: if you’re not in the club, you’re stuck in the slow lane, watching the anointed ones race their next-generation drugs to market. This isn’t just business; it’s a scandal of access, where the rules are rewritten for a privileged few while the rest of the industry is left wondering who’s really calling the shots between Washington and Wall Street.

Original article: CNBC ▸

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