Good Day BIO: Update on Build Back Better

It’s been a minute since we’ve talked about Build Back Better—here’s the latest on the Senate’s version and the expected timeline. We also look at how gene editing can help solve our massive food waste problem, as well as news alerts from JPM and Georgia Bio. (926 words, 4 minutes, 37 seconds)

Update on Build Back Better

Build Back Better, President Biden’s social spending plan (with drug price controls) is making its way through Congress—here’s the latest on the Senate’s version of the bill and timing.

To catch you up: The House passed BBB—with a rushed and highly politicized drug pricing deal—before Thanksgiving. The Senate Finance Committee released their version of the bill last week, and negotiations continue. 

The Senate’s version of the bill still contains the provision allowing the government to set prices of certain drugs—but with some changes. BIO’s Federal Government Relations team and our friends at The Todd Strategy Group compared the two versions (page numbers refer to the Senate Finance Committee proposal). 

Key differences in “negotiation” program legislative text:

• Plasma-derived products from “small biotechs” are not exempt from “negotiation.”  (Pg. 1029)
• A new “nonduplication” provision exempts drugs from negotiation if they are subject to a rebate under section 1927(a)(5)(B) of the Social Security Laws. (Pg. 1034)
• The “determination” of a maximum fair price is exempt from judicial review. For the same provision, the House version refers to “establishment” of a fair price. (Pg. 1037)
• Introduction of “Average Net Price” in Ceiling for Maximum Fair Price Calculation. (Pg. 1038)
• New “Ceiling for Certain Low-Cost Insulin Products.” (Pg. 1041)
• “Clarification” on Removal of Selected Drugs from Formularies. (Pg. 1063)
• Part B inflation cap: The Part B inflation rebate is more aligned with the Part D rebate as it moves dates to begin in January 2023, not July 2023 as written in the House-passed text. (Pgs 1071-1078).

Part D inflation cap:

• Exemption for some generics: “if the Secretary determines that without such reduction or waiver, access to the drug would be severely reduced, the Secretary may reduce or waive the Part D inflation cap.” (Pg. 1091)
• The inflation cap “benchmark period CPI–U” is based on the consumer price index for January 2021, instead of October 2021. (Pg. 1102)
• There is a new section titled “Drug and Biological Described” within the definition of “Part D Rebatable Drug” relating to generic manufacturers. (Pg. 1099)

So, what next? While Senate leadership had hoped to pass the bill before Christmas, that now seems unlikely, especially with President Biden and Sen. Joe Manchin (D-WV) reportedly “at odds” over some provisions—CNBC has more on the timing and what it means. 

There’s still time to weigh in with the Senate—contact your U.S. Senator to tell them why drug price controls will harm patients and cures.

More Health Care News: 

Georgia Bio behind launch of Atlanta health innovation hub
The Center for Global Health Innovation (CGHI), a partnership between Georgia Bio and the Georgia Global Health Alliance, yesterday announced “the launch of a new global health district in Midtown Atlanta that is poised to become the world's leading hub for innovation at the intersection of global health, health technology, and life sciences, solidifying the region as the world's global health capital.” The district will unite Atlanta’s “growing talent pool in life sciences, health technology, and public health,” and be “anchored by 200,000 square feet of conference center, laboratory, and office space leased and operated by CGHI at Tower Square, the 47-story high rise formerly occupied by AT&T."

CNBC: JPMorgan moves annual health-care conference to virtual
“The bank on Wednesday told participants that the 40th Annual J.P. Morgan Healthcare Conference was moving to a virtual format ‘out of an abundance of caution.’” (But don’t worry, BIO’s One-on-One Partnering system was uniquely prepared for this change—read more and register!)

We waste one-third of our food—but gene editing can help

“Over one-third of the food produced in the United States is never eaten,” finds a new report from the Environmental Protection Agency (EPA)—but biotech solutions like gene editing can keep good food out of the garbage.

Food waste is a shame—and not only because people are still going hungry: “Wasted food presents opportunities to increase food security, foster productivity and economic efficiency, promote resource and energy conservation, and address climate change,” says the report, From Farm to Kitchen: The Environmental Impacts of Food Waste. 

Estimates say the U.S. wastes up to 1,032 pounds of food per person per year—about 35% of the U.S. food supply, or 73-152 million metric tons, per the report. 

Take the strawberry: “Roughly 35 percent of the strawberry harvest—perfectly good berries—ultimately end up as waste because they don't hold up, either in stores or post-sale in buyers' refrigerators,” says Innovature.

The EPA report recommends solutions, including…

• “Prevention rather than recycling.”
• Reduce household and restaurant waste.
• Focus on waste of the most resource-intensive foods. 

Gene editing can help strawberries stay in the fridge longer without getting mushy or moldy. A collaboration between J.R. Simplot Company with the “proprietary strawberry germplasm and plant growing expertise” of Plant Sciences Inc. uses CRISPR to produce strawberries that last longer and require less land and water to grow.

Simplot, a BIO member, also developed a potato that doesn’t brown. Although bruised or brown potatoes are perfectly fine to eat, home cooks and restaurants tend to throw them out—but now, Simplot is using gene editing to develop a superior spud. 

President Biden’s Thursday: Giving the Medal of Honor to Sergeant First Class Alwyn C. Cashe, U.S. Army; Sergeant First Class Christopher A. Celiz, U.S. Army; and Master Sergeant Earl D. Plumlee, U.S. Army. In the afternoon, meeting with members of the White House COVID-19 Response Team to discuss the Omicron variant. 

What’s Happening on Capitol Hill: It seems Democrats won’t hold a vote on the Build Back Better spending plan until 2022 because Sen. Joe Manchin (D-WVa) opposes an extension of the child tax credit, CNN reports. The House will hold a hearing on protecting the Smithsonian Collection against climate change.