EPIC Act needed to protect small molecule R&D

The Inflation Reduction Act would discourage small molecule R&D—but lawmakers have proposed one “EPIC” solution. Plus, the potato finally has its day—and biotech is ensuring its longevity. (466 words, 2 minutes, 19 seconds)

EPIC Act needed to protect small molecule drug development

Inflation Reduction Act (IRA) provisions discouraging small molecules imperil drug innovation, but North Carolina’s federal lawmakers have an “EPIC” solution, says North Carolina Life Sciences Organization President Laura Gunter.

The problem: New small molecule drugs, typically pills or tablets, are eligible for IRA price controls nine years after they are released, as opposed to biologics, made using living cells, which receive 13 years of price protection, Gunter explains in The Carolina Journal.

Why it matters: “This arbitrary distinction will distort the incentive structure for those who invest in research and development, because in the first 13 years after FDA approval, years nine to 13 account for about 50% of the revenue a new drug generates. So the IRA is, quite understandably, already driving investors to favor biologics over small molecules.”

The potential damage: “One expert analysis estimated that, in total, the IRA will lead to 79 fewer small-molecule therapies being developed and 116 million life years lost over the next two decades,” Gunter explains.

A solution: “The bipartisan EPIC Act would equalize the period of price-control exemptions for small-molecule drugs and biologics at 13 years,” Gunter writes. The bill was introduced by Reps. Greg Murphy, M.D. (R-NC), Don Davis (D-NC), and Brett Guthrie (R-KY).

The bottom line: “The bill will reverse this misguided policy and restore incentives for small-molecule drug development. Passing their bill would protect local jobs, boost North Carolina’s economy, and help countless patients in need,” Gunter writes.

Read the full opinion piece.

Potatoes have their day, with support from biotech

A staple for two-thirds of the world, the potato is a great candidate for genetic improvement and already benefits from biotech.

Finally having its day: Today is the first UN International Day of Potato, celebrating a crop that contributes to the Sustainable Development Goals (SDGs) by reducing hunger, promoting sustainable agriculture, and advancing economic opportunities. Potato cultivation also produces relatively low greenhouse gas emissions.

A good crop for biotech: A study released last week details success in making potatoes more resistant to zebra chip disease through CRISPR-Cas9 gene editing. Potatoes are difficult to crossbreed with traditional methods, making biotech the best way to improve the crop.

Game-changer in Africa: The first year of Nigeria’s Genetically Modified (GM) Potato Project, USAID-backed trial cultivation of potatoes resistant to the late blight devastating that country’s crop, produced 300% better yields than non-GM potatoes. The heartier potatoes will be widely available to Nigerian farmers next year.

U.S. advances: With U.S. consumer acceptance of genetically engineered potatoes growing, BIO member J.R. Simplot is leading the development of disease-resistant, bruise-resistant potatoes. 

What’s next: Global production has increased 10% in the last decade, and Michigan State University researchers recently cleared a regulatory hurdle for gene-edited potatoes to make healthier fries and chips.

President Biden’s Thursday: A day in Rehoboth Beach, DE.

What’s Happening on Capitol Hill: Recess.