President Biden today unveiled details of the White House’s budget request that included drastic changes to the Medicare program, including further expanding the program’s new authority to institute price controls in Medicare. BIO Chief Advocacy Officer, Nick Shipley, made the following statement: “The President’s plan to expand Medicare price controls is another costly blow to the millions of patients depending on innovative cures, particularly those in the rare and orphan drug space. The White House hasn’t even implemented the pharmaceutical provisions in the Inflation Reduction Act, yet they are already proposing to further destabilize Medicare, slow critical investment in future research and development, stall drug innovation, and ultimately harm patients. Press reports indicate HHS wants to double the size of the price control program, without even the slightest acknowledgement about impacts on diseases like oncology or Alzheimer’s.    “These impacts are then disproportionality felt by the very small biotechnology businesses that are responsible for nearly 80% of the treatments in the clinical pipeline. These companies rely on stable investing market to stay afloat. They are also responsible for the lion's share of medical innovation, helping millions of Americans live longer and healthier lives. Without a healthy investment environment, the cures of tomorrow might never reach the patients who desperately need them. “BIO supports legislative solutions to bolster medical innovation and increase patient access to medicines. We’ve consistently advocated for patient out-of-pocket caps and a crackdown on pharmacy benefit managers – the middlemen in the drug supply chain responsible for inflating drug prices.  Much like the IRA was a gift to pharmacy benefit managers by preserving their kickback schemes, the Budget represents another missed opportunity to address one of the biggest drivers in drug pricing. “While this latest proposal is an attack…

A broad coalition of national and state agriculture and bioscience organizations have written President Biden to thank the administration for beginning technical consultations with Mexico concerning its action to ban imports of biotech corn. The groups are calling for those consultations to start without delay. “We support your administration’s request for consultations with Mexico regarding its treatment of agricultural biotechnology and denying the use of certain crop protection tools, to provide a framework and timeline to resolve this issue,” the 65 groups wrote. “We look forward to these consultations beginning promptly.” Technical consultations bring leaders from the involved countries, which now includes Canada as well, into formal discussions to resolve the dispute. If the talks are not successful, the U.S. can initiate a dispute settlement under USMCA. The organizations expressed appreciation for the administration’s efforts over several months to resolve the issue through negotiations but indicated that the results, including a revised decree that Mexico issued Feb. 13, 2023, are inadequate, and now it is time for action. The new decree, which the groups said drew a non-science based distinction between corn for food and corn for feed and industrial uses, is inconsistent with USMCA obligations. The new decree “continues to limit the use of innovative agricultural tools, extends restrictions on safe crop protection products, and enacts barriers to trade,” the groups wrote, and it “fails to establish a science- and risk-based regulatory approval process for all agricultural biotechnology products and ignores the immediate need to establish a risk assessment process for gene editing technology.” The agriculture and biotechnology groups reiterated the importance of beginning the legal process to not only resolve the dispute with Mexico but also prevent other countries from following suit. “The United States must use the dispute mechanisms afforded in…

The Biotechnology Innovation Organization appreciates that USDA and the Biden Administration are aiming to increase access to modern, innovative seeds. We are reviewing USDA’s report, “More and Better Choices for Farmers: Promoting Fair Competition and Innovation in Seeds and Other Agricultural Inputs,” to identify potential concerns about weakening intellectual property protections for biotech companies. Strong patents, and an efficient, predictable and objective patent system, are critical to the seeds industry, which depends on patent-driven activities to fuel the development of new inventions and products that benefit the public. The patent system helps drive the development of improved seed and crop protection products that address challenges such as increasing harvests, allowing conservation of arable land and, ultimately, helping to feed the world’s growing population. Notably, almost all the foregoing activities are highly regulated by government agencies such as the FDA, EPA and USDA, which have decided that these developments are socially useful and should be promoted. However, one of the greatest challenges to expanding biotech’s benefits to more producers, as well as growing agriculture’s sustainability and the world’s food security, is the cost and time it takes to bring new traits to market due to the regulatory structure. Studies have found that over the past decade, the cost of regulation for biotech trait commercialization has grown more than 23 percent while regulatory timeframes grew 75 percent. While scientific advancements have made commercialization more efficient, the resulting cost and time savings have been nearly canceled out by increases in regulatory costs and delays. Identifying and addressing such barriers to biotech innovation, as called for in President Biden’s Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe and Secure American Bioeconomy, is the best way to increase farmers’ and…

The Biotechnology Innovation Organization welcomes today’s announcement by the Office of the U.S. Trade Representative that it is initiating a technical consultation with Mexico over that country’s plan to ban imports of biotech corn. “BIO applauds the efforts of USTR and USDA to resolve this issue through negotiations,” said Nancy Travis, vice president for international affairs at BIO. “However, it’s time to send a strong message to the government of Mexico and return to the science-based trading system and obligations to which both our countries committed when we signed the U.S.-Mexico-Canada Agreement. “In addition to the economic harm that Mexico’s proposed ban will have on U.S. corn producers, the ban will have a devastating impact on the agricultural innovation needed to achieve our climate goals and ensure we can meet the world’s growing demand for food. BIO has called for the Biden Administration to use the dispute settlement process in USMCA to provide a framework and timeline to resolve this issue. Today’s announcement of a technical consultation with Mexico is a vital first step to restoring policies that enable farmers to use agricultural biotechnology products and improve food security and sustainability.”