Today, the Supreme Court announced it will soon weigh in on a case that challenges how the Food and Drug Administration (FDA) regulates mifepristone, a drug it approved almost 25 years ago. BIO interim president and CEO, Rachel King, made the following remarks: “The unprecedented suspension of mifepristone -- a drug that had been approved by the FDA and on the market for nearly 25 years -- earlier this year was a significant overreach of the courts and a major disservice to patients relying on biomedical innovation.  "Preserving and protecting the FDA's authority to make determinations about the approval of lifesaving and life-enhancing therapies has been -- and will continue to be -- critically important to both ensuring it is able to meet its mission to protect and promote the public's health and to ensuring there are clear paths forward for new waves of innovation for patients suffering from a wide range of illnesses. 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.  "We are pleased the Supreme Court will soon hear this important case. As we have warned repeatedly, this decision has long-term ramifications that extend well beyond a single drug. We will continue fighting on behalf of patients and our member companies to ensure groundbreaking scientific ideas in labs have the opportunity to benefit our neighbors and loved ones for years to come."

Most Americans Recognize that Biotech Is ‘Climate Tech’ A new poll from the Biotechnology Innovation Organization (BIO) shows that majorities of Americans agree that biotech plays an important role in addressing climate change and federal policymakers should incentivize biotech innovations that solve problems associated with climate change. Four in five Americans view climate change as a threat to global food security and public health — and most agree biotechnology has a significant role in protecting both. “When you look at the many ways in which biotech companies are rising to the challenge of reducing and mitigating climate impacts, there is no question that biotech is ‘climate tech,’” said Beth Ellikidis, vice president for agriculture and environment at BIO. “Whether developing crop traits to withstand more challenging growing conditions or plant-based materials to replace fossil-based materials, these technologies are helping to reduce waste, emissions, or both.” According to the new poll, more than half (51%) of Americans say not enough is being done to address climate change, but the American public is generally confident that the biotechnology industry will play a positive role in promoting food security (78%) and public health (75%) in the face of climate change. Additionally, 66% say federal policymakers should prioritize incentives for biotech companies to devote resources to solving the challenges brought by climate change. The poll was conducted Nov. 23 – 25, 2023, among a sample of 4,411 adults, and has a margin of error of +/- 1%. BIO commissioned Morning Consult to conduct the poll. There are already several biotech solutions that can reduce climate impacts: Crops that are bioengineered to withstand harsh environments and rising pressure from pests and diseases; Produce engineered to stay fresh longer and reduce food waste; Alternatives to synthetic fertilizers; Animal feed additives that support digestive efficiency and can reduce…

Today, the Biotechnology Innovation Organization released a poll that shows voters overwhelmingly support the ORPHAN Cures Act, a recently introduced bill that would incentivize rare disease drug development.  The ORPHAN Cures Act would fix a provision in the Inflation Reduction Act that punishes biopharmaceutical companies for discovering multiple rare disease applications for the same medicine. Of the more than 280 orphan drugs approved since 2003, nearly a quarter were later approved to treat additional diseases.According to the survey, 94% of American voters think it's important for scientists to search for rare disease treatments, while 85% agree it is critical for the government to "expand incentives for rare disease drug development.""Americans clearly want our best and brightest scientists working on rare disease treatments,"said BIO CEO Rachel King. "This bill is a beacon of hope for the 30 million Americans suffering from rare diseases." 1Nearly 80% of American voters agree that the federal government shouldn't prevent scientists from researching treatments for multiple rare diseases. Additionally, almost 70 percent would support their congressional representatives voting for the ORPHAN Cures Act -- and nearly 40 percent would "strongly support" this (only 5 percent oppose; with 14 percent having no opinion or don’t know). "Right now, 95% of rare diseases have no FDA-approved treatment. As this poll shows, Americans want lawmakers to incentivize the scientific pursuit of these much-needed treatments," added King. The poll, conducted by Morning Consult, surveyed 1,990 registered voters between November 23 and November 25, 2023. Results have a margin of error of plus or minus two percentage points.Click here to view the full results of the poll. About BIO:  BIO is the premier biotechnology advocacy organization representing biotech companies, industry leaders, and state biotech associations in the…