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Ending the week with USDA nominee Alexis Taylor’s hearing at the Senate Ag Committee, BIO’s webinar on the impacts of the new drug price controls—and a deal on prescription drug user fees. Enjoy the weekend. (883 words, 4 minutes, 24 seconds) |
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USDA nominee calls for ‘science-based decision-making’ in Mexico |
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The Senate Agriculture, Nutrition, and Forestry Committee held a hearing yesterday on several administration nominees, including Alexis Taylor to be Under Secretary of Agriculture for Trade and Foreign Agricultural Affairs—here’s what happened.
Alexis Taylor,current Director of the Oregon Department of Agriculture, was raised on an Iowa farm. She’s had a long career in public service, including time at the USDA, making her “uniquely qualified for this role,” BIO and other industry groups said in a letter of support in June.
We need to ensure “science-based regulatory requirements are enforced—especially when it comes to GMO corn trade with Mexico, said Sen. Joni Ernst (R-IA).
Mexico is “set to ban biotech corn as soon as January 2024, and this policy is definitely out of step with the commitments that were put in the [U.S.-Mexico-Canada Agreement],” said Sen. Deb Fischer (R-NE). “If confirmed, will you work with your USTR counterparts to enforce the USMCA’s biotechnology provisions and, if necessary, to advocate for the United States to take enforcement action?”
Catch up: Mexico’s GM corn ban a lose-lose scenario, study confirms
“Should I be confirmed, I am very interested in engaging within the administration on what’s going on in Mexico around biotechnology and [with] my counterparts in Mexico to ensure we’re advancing science-based decision-making around the use of these critical tools,” said Taylor.
“The underlying point here is about using science to make informed regulatory decisions,” continued Taylor. “That is how we do it in the United States, that is our expectation of our trading partners around the world.”
Why it matters: “We have huge challenges we’re experiencing globally. The war in Ukraine and the global food insecurity crisis that’s really exacerbating, coming off the heels of the global pandemic, climate change and the impacts to production,” said Taylor. “We’re going to need advancements in science and technology globally to address those challenges and continue to feed our growing world population.”
More Agriculture & Environment News: Agri-Pulse: Ag groups urge Senate to vote on McKalip BIO, several of its member companies, and a broad and diverse set stakeholders in American agriculture sent a letter to Senate leadership urging a final floor vote on Doug McKalip’s nomination as Chief Agricultural Negotiator in the Office of the United States Trade Representative (USTR). The Senate Finance Committee unanimously approved McKalip’s nomination over two weeks ago. |
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The impact of the Inflation Reduction Act on the biotech sector |
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The Inflation Reduction Act contains historic climate investments—as well as drug price controls that are expected to kill drug innovation and hamper the development of new treatments, said BIO experts during a webinar yesterday.
What it means: “The vast majority of venture capital and private equity that flows into the biotech ecosystem, which is frankly critical for the startup biotech economy, is going to have new net present value calculations that they’re going to be evaluating,” explained John Murphy III, BIO’s Chief Policy Officer and Deputy Counsel for Healthcare, during BIO’s webinar earlier this week on the law’s drug provisions.
Here’s why: “You have a law that sets up a differentiated environment for large molecule and small molecule drugs,” he continued. “There is an exclusivity canceling date that is predictable in certain circumstances, particularly as you get later in the law where more and more products are captured by this cumulative negotiation paradigm that’s going to affect the valuation calculus.”
Data backs it up: A 2021 Vital Transformation study (funded by BIO) found that every 10% drop in the price of medicines after price controls were implemented in the EU led to a 14% decrease in venture capital funding and a 9% decrease in biotech start-up funding.
The bottom line: These price controls are undoubtedly going to affect the U.S. biotech sector in a negative way—though it’s not clear yet exactly how much of a hit the sector will take.
Want to know more? BIO’s members-only webinar was an efficient how-to on dealing with the drug pricing program, Medicare Part B and Part D inflation rebates, and more—watch and read the highlights.
More Health Care News: Bio.News: How the European Health Data Space (EHDS) will impact companies operating in the EU The European Health Data Space (EHDS) will change how patients, doctors, researchers, and policymakers access and use health data, and also affect companies operating in – or about to enter – the EU, writes Leander Vranken, Digital Health Policy Officer at the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), in a Bio.News exclusive. |
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President Biden’s Friday: Delivering remarks at a DNC event in D.C., where he’s expected to focus on Biden’s “economic agenda and legislative wins,” as well as abortion rights, per CNN. This evening, he’s hosting Sir Elton John for a performance at the White House.
What’s Happening on Capitol Hill: Yesterday, lawmakers within the Senate HELP Committee and the House Energy and Commerce Committee reached a deal to reauthorize the FDA’s user fee programs for five more years. “BIO has long touted the importance of PDUFA, and we’ve been very vocal about the need for timely reauthorization this year," said BIO's Dr. Michelle McMurry-Heath. "While we eagerly await final passage, the announcement of a deal to reauthorize the user fee agreements paves the way for continued stability for the FDA and its ability to usher in the next generation of medicines and safeguard public health [… and brings] some much-needed stability to biopharma companies working on the next generation of cures. This is especially crucial for the small and mid-sized companies responsible for the lion’s share of biomedical innovation.”
Meanwhile, BIO members spent Tuesday and Wednesday meeting with over a dozen House and Senate offices to share the specific impact of R&D amortization on the biotech community. This tax change was enacted as a pay-for in the 2017 Tax Cuts and Jobs Act but took effect calendar year 2022. BIO and members explained how the new tax law disincentivizes investments and partnerships in small, early-stage biotech projects, threatening chronic and rare disease R&D project pipelines.
While there is strong bipartisan support across the Capitol to delay this tax change, time is running out to pass a legislative fix before the new year. BIO members stressed the importance of including such a fix in any remaining must-pass vehicles, specifically an end-of-year tax extenders package in December. BIO will continue to advocate for a fix before the 117th Congress ends this winter. |
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