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The Readout Damian Garde & Meghana Keshavan

Actually, the FDA is strict

After years of criticism that the FDA has been too lax when it comes to drug companies that don’t disclose clinical trial results, the agency cracked down on a biotech firm that has been dragging its feet.

As STAT’s Ed Silverman reports, the FDA issued its first-ever citation to Acceleron Pharma, threatening the company with escalating fines if it doesn’t post study results to ClinicalTrials.gov within 30 days. Legally, study sponsors are required to post summary results to the federal website after trials conclude, but despite the presence of hundreds of violators across academia and industry, the FDA had, until now, never issued a notice of noncompliance.

That raises an obvious question: Why now? For years, transparency advocates have pressured the agency to do something like this, arguing that the laws around data disclosure are toothless unless the FDA enforces the penalties at its disposal. It’s unclear what transpired to put Acceleron in the agency’s crosshairs, but it’s worth noting that in 2016, then-Vice President Biden threatened to cut funds to medical research institutions that fail to report results in a timely manner.

Read more.

Actually, the FDA is lenient

After years of criticism that the FDA has been too lax when it comes to approved drugs that don’t live up to expectations, a group of agency advisers voted over and over again that there’s nothing wrong with that.

The issue is cancer immunotherapies that get accelerated approvals for certain tumor types and then later turn out not to provide substantial benefits for those patients. The FDA has termed these “dangling approvals,” meaning they can later be yanked, and this week it convened a panel of experts for advice on how to act. In three votes across two days, the majority of those experts said the approvals should remain intact. Three more votes are slated for today, and it seems likely they’ll go the same way.

The FDA is not required to follow the advice of its experts, but it most commonly does. If the agency decides not to exercise its rights when it comes to rescinding approvals, outside critics will argue that it’s undermining the whole point of the accelerated approval pathway. Then there’s the message it might send the drug industry. Ahead of this week’s meetings, four cancer drug makers voluntarily withdrew certain approvals. Considering how things are playing out, they might be less inclined to do so next time.

Biden wants drug pricing reform — just not enough to prioritize it

In his first address to Congress, President Biden asked lawmakers to let Medicare negotiate drug prices. But the idea is nowhere to be found in the administration's sweeping proposals to reform the social safety net, making Biden’s words an empty call to action.

As STAT’s Rachel Cohrs reports, Biden’s decision to snub drug pricing legislation might have more to do with practicality than ideology. Passing a trillion-dollar domestic policy package is already going to take substantial time and political capital. Throwing drug pricing into the mix could imperil Biden’s signature legislation in the early days of his administration.

But to advocates for reform, that sounds like a cop-out. As recently as this month, the White House signaled that reducing the cost of medicine would be a cornerstone of its American Families Plan. By leaving it behind, “they are saying we still want this, we’re just not going to do it,” said Chris Holt, director of health policy at the American Action Forum.

Read more.

Pharma’s pandemic slump might have a long tail

Despite receiving more positive press than ever in modern history, the world’s largest drug makers struggled to maintain their bottom lines last year, as the pandemic imperiled the doctor visits and prescription refills they count on for revenue growth. And if the first quarter of 2021 is any indication, the industry isn’t out of the woods yet.

Yesterday, GlaxoSmithKline reported a 15% decline in sales compared to the same period last year. Hours before, Amgen missed Wall Street’s earnings and revenue projections for the first time in three years, with sales falling 5% year-over-year. A day earlier, Eli Lilly surprised the market with a downbeat quarter and a reduction to its 2021 projections.

To some extent, each firm can blame the pandemic for its underperformance (just as the likes of Pfizer and Johnson & Johnson have been insulated by virtue of selling Covid-19 vaccines, the world’s most in-demand products). But analysts caution that the temporary problems caused by Covid-19 may have revealed festering issues in drug makers’ business models. As SVB Leerink analyst Geoffrey Porges pointed out, Amgen is steadily losing pricing power on some of its biggest products, which has nothing to do with the pandemic, and the same goes for GSK’s repeated setbacks in developing new medicines that might replace its aging products.

More reads

  • Glowing tumor-munching cells, captured on video, show the promise of a new approach to CAR-T cancer therapy. (STAT+)
  • Another class of biotech companies are about to go public in Massachusetts. (Boston Globe)
  • Needed: an Operation Warp Speed for the opioid epidemic. (STAT)
  • U.S. watchdog mulls guidance to curb SPAC projections, liability shield. (Reuters)

Thanks for reading! Until tomorrow,

Thursday, April 29, 2021

STAT

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