Supreme Court to hear case on FDA’s authority

The Supreme Court will hear a case that will determine whether courts can overrule FDA’s authority on drug approvals—here’s what’s happening. Plus, President Biden is expected to tout drug price controls today. (581 words, 2 minutes, 54 seconds)

Supreme Court to hear case on FDA’s authority

The Supreme Court announced it will rule whether a federal judge has the right to restrict Food and Drug Administration (FDA) approval of drugs.

The background: After a federal judge in Texas invalidated the FDA’s nearly 25-year-old approval of mifepristone last year, the Texas Fifth Circuit Court of Appeals upheld the legality of the drug, but blocked subsequent FDA rulings allowing the drug to be prescribed by telemedicine or sent through the mail.

Yesterday’s announcement means the Supreme Court will decide whether to strike down the appeals court ruling and preserve the FDA’s authority. 

BIO’s take: “The FDA has not only the mandated authority, but also the scientific and medical expertise that has established the agency as the best in the world. Undermining this authority and expertise would create within the biomedical industry massive uncertainty and significant barriers to advancing the next wave of innovation,” said BIO’s interim President and CEO Rachel King.

Why it matters: “If left to stand, the opinion would dramatically alter the FDA’s ability to modify drug approvals to keep pace with science — and would effectively open the door for any physician, whether or not they treat patients using the drug in question, to challenge the FDA’s approval,” write BIO Board member Grace E. Colón, Ph.D., and former FDA official Eva A. Temkin in STAT News.

What’s next: “The case will be heard this term, with a decision likely by summer,” reports NPR.

Colorado BioScience Association awards BIO Business Partner of the Year

BIO was recognized at the 20th Annual Awards Celebration of the Colorado BioScience Association (CBSA). The awards recognize members of “Colorado’s life sciences community who are forging new frontiers for patients.”

Pictured: Dr. Kiki Traylor, Amgen and CBSA Board Chair; Katelin Lucariello, PhRMA; Brian Warren, BIO; and Elyse Blazevich, CBSA

Can biotech help avert a ketchup crisis?

As climate change makes times tough for tomatoes, biotech researchers are working to keep ketchup (and other foods) on the table.

What’s happening: California’s droughts have wrecked almonds, alfalfa, and tomatoes. With more than 90% of U.S. tomatoes for sauces and pastes coming from California, we need plants that can withstand severe weather, The Wall Street Journal reports.

Enter biotech:Scientists in Israel studying a wild tomato variety from Peru found two specific areas in the genome lead to a 20%-50% increase in overall yield and a reduced thirst. They have crossbred this plant with a domestic plant to make a tomato that requires half the water of other commercial breeds.

Gene editing helps tomatoes in other ways, increasing their level of vitamin D and making plants with enhanced antioxidants.

Gene editing makes other plants less thirsty, enabling drought-resistant wheat, corn, soybeans, and rice.

Heartier corn can also grow in colder climates: BIO member Corteva is working on new corn varieties able to grow in newly warmer places like western Canada.

We must act fast: “The challenge we’re facing is the speed at which it (climate) is changing,” so making heartier plants is an urgent need, Wendy Srnic, VP of biotechnology at Corteva, tells the WSJ.

President Biden’s Thursday: Visiting NIH today, where he’s expected to tout the Inflation Reduction Act’s drug price controls, per The Hill.

What’s Happening on Capitol Hill: The Senate Health, Education, Labor & Pensions Committee will hold a hearing, “What is Fueling the Diabetes Epidemic?”