This bill would fix IRA orphan drug incentives

It’s already a busy week on the Hill—starting with legislation introduced yesterday that would fix the Inflation Reduction Act’s orphan drug incentives. Today’s new episode of the I am BIO Podcast explores how biotech is saving the bees. (624 words, 3 minutes, 7 seconds)

This legislation would fix IRA’s orphan drug incentives

Legislation introduced yesterday would amend the Inflation Reduction Act (IRA) to better support the discovery of orphan drugs for rare diseases—and BIO likes it.

Catch up:The IRA exempts orphan drugs for rare diseases from price negotiations—but only if the drugs are approved for a single indication. Drug manufacturers are disincentivized to test whether a new drug can treat other indications.

The problem: By discouraging research into second indications, the IRA hinders the discovery of orphan drugs, according to Vital Transformation and a recent JAMA study.

A possible solution: The Optimizing Research Progress Hope And New Cures (ORPHAN Cures) Act, introduced by Reps. John Joyce (R-PA) and Wiley Nickel (D-NC) yesterday, “changes the incentive structure within IRA to encourage follow-on investment into orphan drug development,” says BIO President and CEO Rachel King.

Why it matters: While it’s difficult to reverse the IRA’s innovation-killing drug price controls, the harmful orphan drug provision is something both parties want to fix fast, said King on a recent podcast.

BIO’s take: “Reversing IRA’s perverse incentives will eliminate the significant barrier for scientists to usher in new waves of rare disease drug innovation—all to the benefit of the thousands of patients currently suffering from rare diseases,” says King. “BIO looks forward to working with lawmakers” to pass the ORPHAN Cures Act.

Buzz off, parasites and pathogens

Biotech is helping preserve bees, which are essential to our survival, explains the new episode of the I am BIO Podcast released today. 

Why it matters: Bees and other pollinators necessary to one-third of our food supply are under pressure from parasites, pathogens, and climate change. Starting in 2006, beekeepers reported colony collapse disorder, destroying 30%-60% of hives, says podcast host Rachel King.

“I’m really hopeful about the potential for science, biotech,” says Pollinator Partnership’s Kelly Bills. “There’s some really cool research happening and really cool innovations in terms of how to fight some of the pests and pathogens that are impacting bees.”

Mitigating mites: Varroa mites, which attach to a bee’s thorax and suck out nutrients, can wipe out a hive. GreenLight Biosciences battles mites with RNA, “the oldest biomolecule in our planet…the origin of life,” says CEO Andrey Zarur.

Targeted treatment: “The beauty of the RNA solution is we can design it to target specifically the genome of the Varroa mite and minimize any kind of collateral damage,” Zarur says. GreenLight awaits Environmental Protection Agency approval.

A deadly bacteria, American foulbrood impacts about half the world’s beehives—but Dalan Animal Health developed an effective vaccine, says CEO Annette Kleiser. The revolutionary idea of a vaccine for bees was only possible after the recent discovery that insects have an immune system. Dalan has developed the first USDA-approved vaccine for bees, which is available now to improve resilience to foulbrood.

The bottom line: Biotech may save bees, “one of the many ways that modern biotech is making revolutionary gains to improve the health of people and our planet,” concludes King. 

Listen: Catch the new episode at www.bio.org/podcast or your favorite podcast app.

President Biden’s Tuesday: Attending the UN General Assembly, where he’s expected to be the only top leader from the five Security Council countries, per The New York Times.

What’s Happening on Capitol Hill: Two House hearings will address the problem of pharmacy benefit managers (PBMs) driving up the price of prescription drugs: The Energy and Commerce Health Subcommittee legislative hearing, Examining Policies to Improve Seniors’ Access to Innovative Drugs, Medical Devices, and Technology, will look at two bills to prevent PBM abuses. The Oversight and Accountability Committee will also hold a hearing, The Role of Pharmacy Benefit Managers in Prescription Drug Markets Part II: Not What The Doctor Ordered.

Tomorrow, the House Energy & Commerce Oversight and Investigations Subcommittee will hold a hearing, How the IRA’s Price Setting Scheme Means Fewer Cures for Patients. John Crowley, Chairman of Amicus Therapeutics and BIO Board member, will testify.