Washington, DC (February 11, 2019) – Today, to recognize National Inventors’ Day, the Biotechnology Innovation Organization (BIO) released a new report, “Science or Compliance: Will Section 404(b) Compliance Impede Innovation by Emerging Growth Companies in the Biotech Industry?” The report shows the detrimental impact of Sarbanes-Oxley 404(b) on biopharmaceutical emerging growth companies (Bio-EGCs) and demonstrates how this regulatory requirement harms innovation and capital formation without any corresponding investor benefit. “It’s an exciting time for the life sciences sector,” BIO’s President and CEO Jim Greenwood noted, “but we must do more to protect small business innovators from regulatory burdens that are counterproductive to their mission. As this study proves, failing to exempt pre-revenue biotech companies from costly and unnecessary regulations is harming innovation, capital formation, and the ability of companies to develop breakthrough medicines and cures.” The study was conducted by renowned economists, Craig Lewis, a Senior Advisor at Patomak Global Partners and Professor of Finance and of Law at Vanderbilt University, and Joshua T. White, Assistant Professor of Finance at Vanderbilt University.  In it, the scholars point to mounting evidence that links Section 404(b) compliance to reduced market capitalization, higher audit fees, exiting of public markets, and a direct reduction in innovation such as R&D that results in fewer patents.   Under the JOBS Act, enacted in 2012, small companies like Bio-EGCs were granted a five-year exemption from the costly Section 404(b). Since the law’s passage, more than 300 Bio-EGCs have gone public representing a 270 percent increase compared to the same period prior to JOBS Act. However, because drug development is an exceptionally time-consuming endeavor and often requires a decade or more of research and development, many life science startups are still pre-revenue when…

The Biotechnology Innovation Organization (BIO) announced today that after 19 years leading the Industrial and Environmental Section, Executive Vice President Brent Erickson will step down from the organization in March 2019 to begin new business ventures. 

But New Legislative Proposals Endanger Progress

BIO applauds the leadership of Senator Thom Tillis (R- NC) and Congressman Bill Flores (R-17 TX) for introducing the “Hatch-Waxman Integrity Act of 2019” to preserve the time-tested approach of the HWA while strengthening the ability of patent owners to fairly defend against abusive efforts to invalidate patents for innovative life-saving medical therapies.

BIO’s President and CEO Jim Greenwood issues statement on President Trump’s State of the Union Address.

BIO’s President and CEO Jim Greenwood issued a statement after the Trump administration released a proposed rule that would alter safe harbor policies under the federal anti-kickback statute.

"President Trump has taken unprecedented measures to take on China – our largest trading partner – for its history of trade abuses. Beijing has long imposed unjustified restrictions on U.S. companies seeking to do business in and export to China, particularly with respect to agricultural products. "With Chinese Vice Premier Liu He in Washington to participate in bilateral trade talks, the Trump administration should remain steadfast in pushing China towards structural reforms of its market. This means that any prospective trade deal with China cannot be based simply on a promise to buy more U.S. products. Such a bargain would fail to address the longstanding impediments that have contributed to the trade deficit with China. "Any trade deal must require systemic change from China when it comes to U.S. agricultural exports. It’s time for the Chinese government to implement a predictable, timely, transparent and science-based decision-making process that facilitates trade and the importation of agricultural biotechnology products. "Under China’s current opaque regulatory system for agriculture, Beijing arbitrarily dictates what technologies our farmers can use to address production challenges such as pests and drought. This month, Beijing approved only five of the 10 biotechnology crops seeking Chinese market access. Many of the still-unapproved products have languished in China’s regulatory process for more than six years – with no rational or legitimate scientific basis for the hold-up.  "As we near the March 1 deadline for a trade deal, U.S. Trade Representative Robert Lighthizer, Treasury Secretary Steve Mnuchin and Commerce Secretary Wilbur Ross must be resolute and insist on a deal with enduring commitments and not only purchases of U.S. goods. Any trade deal lacking fundamental reform is inadequate and only will exacerbate the inequities in our existing trading relationship that President Trump rightly is trying to…