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BIO Comments on FDA Draft Guidance on Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment

Letters, Testimony & Comments • October 8, 2018

BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment. The draft guidance is an important step in clarifying the FDA’s view of endpoints to demonstrate efficacy of therapies to treat opioid use disorder (OUD). It’s important to expand primary and secondary endpoints in clinical trials for medications to treat opioid use disorder, including the outcomes patients and clinicians said were important to them at the public meeting on patient-focused drug development for opioid use disorder. BIO requests clarification on how the FDA defines relapse to illicit opioid use, and requests FDA consider other possible endpoints to demonstrate effectiveness of drugs. BIO recommends the FDA provide additional detail on Phase III studies for medication assisted treatments.

Press Release • October 4, 2018

Washington, D.C. (October 4, 2018) – Biotechnology Innovation Organization (BIO) President & CEO James C. Greenwood today issued the following statement on the United States-Mexico-Canada Agreement (USMCA):“BIO supports the USMCA and appreciates the Administration’s efforts to prioritize biotechnology innovation, including provisions that update intellectual property protections and agricultural market access to 21st century standards.“Strong and dependable intellectual property standards are critical to fueling innovation, attracting investment, and ensuring that patients, farmers, and consumers around the globe have access to the next generation of biotechnology breakthroughs. The USMCA represents an important step in bringing Mexico and Canada closer to high U.S. standards that have made us the world leader in biotechnology innovation.“The U.S., Mexico and Canada also have a long history of cooperation in the area of agricultural biotechnology, the USMCA builds on this by advancing provisions to facilitate trade and ensure cooperation on future innovation in biotechnology.“Thanks to the Administration’s leadership, the U.S. and our neighboring countries will continue to drive global innovation, ingenuity and ground-breaking science.“The USMCA sets important new standards for U.S. trade policy by ensuring trading partners establish policies that protect, respect, and advance the hard work and investment needed to bring new biotechnology innovations from the lab to the marketplace.”

Press Release • October 4, 2018

"Innovation and bad public policy cannot coexist. That’s an important message often neglected in the debate about health care costs, and that’s precisely the message this organization will help deliver.”

Letters, Testimony & Comments • October 2, 2018

On September 24, BIO submitted final comments in response to the CY 2019 Outpatient Prospective Payment System Proposed Rule. This year’s OPPS rule included a Request for Information (RFI) around the potential development of a new innovation model for delivery of Part B drugs, using CMS’ authority under the previously existing Competitive Acquisition Program (CAP) – of which the original iteration was discontinued in 2008 after failing to attract participants and costing more than the traditional reimbursement structure in Part B.BIO outlined the need for CMS to be thoughtful and measured in the development of models that are voluntary and support a competitive, market-driven approach, including that any models properly address: (1) adequate protections for patient access to clinically appropriate care and lowering costs to beneficiaries; (2) not creating interference that erodes the existing coverage and reimbursement structure, (3) encouraging robust competition and avoiding misaligned incentives; (4) ensuring workability for physicians who may choose to participate; (5) considering appropriate exemptions for certain drugs and biologicals; and (6) transparency in model design, development, and assessment processes.

Press Release • September 27, 2018

Bill reforms tax rules that currently penalize investment in job creation, innovation Washington, DC (September 27, 2018) – The Biotechnology Innovation Organization (BIO) today applauded the House of Representatives for passing the American Innovation Act of 2018 (H.R. 6756), which includes a provision that would protect investments in start-ups from inadvertently triggering the net operating loss (NOL) limitations under Section 382 of the tax code. R&D-intensive biotech start-ups frequently accumulate substantial NOLs in their early, pre-revenue years, given their typical reliance on investor capital for more than a decade before realizing any product revenue.

Letters, Testimony & Comments • September 27, 2018

September 21, 2018The Honorable Richard Shelby The Honorable Patrick LeahyChairman Vice ChairmanCommittee on Appropriations Committee on AppropriationsU.S. Senate U.S. SenateWashington, D.C. 20510 Washington, D.C. 20510The Honorable Rodney Frelinghuysen The Honorable Nita LoweyChairman Ranking MemberCommittee on Appropriations Committee on AppropriationsU.S. House of Representatives U…

Press Release • September 26, 2018

Washington, D.C. (September 26, 2018) – The Biotechnology Innovation Organization applauds the House and Senate’s bipartisan passage of the Small Business Innovation Protection Act. The bill directs increased cooperation between the Small Business Administration (SBA) and the U.S. Patent and Trademark Office (PTO) to improve intellectual property protections for small businesses.The following statement may be attributed to BIO’s President of Advocacy, Law & Public Policy, Tom DiLenge:“Strong intellectual property (IP) protections sustain our nation’s global leadership in biotechnology innovation and the creation of high-wage, high-value jobs throughout our country. By passing the Small Business Innovation Protection Act, Congress has provided enhanced tools to equip American innovators to defend their valuable inventions against infringement both domestically and abroad.“I commend Senators Peters and Risch and Representatives Evans and Fitzpatrick for their leadership on this bipartisan legislation, which recognizes the vital role that small businesses play in driving America’s innovation economy. By providing IP training through the Small Business Development Centers, this new law will foster growth in the jobs of the future.“Study after study confirms that protecting IP is the key to innovation and economic growth. IP-intensive industries employ over 45 million Americans. The average worker in an IP-intensive industry earns about 46% more than his or her counterpart in a non-IP-based industry.“Strong patents are the lifeblood of the biotechnology industry. They are critical in ensuring a steady stream of capital to biotechnology companies developing innovative medicines and more sustainable sources of energy and agricultural products. And they are essential to the technology transfer process that leads from inventions in the lab to products on the shelves. Yet too often, small businesses lack the resources and know-how to protect their valuable IP assets.“The…

Biodefense • Press Release • September 25, 2018

Legislation will strengthen pipeline of medical countermeasures against serious public health threats Washington, DC (September 25, 2018) – The Biotechnology Innovation Organization (BIO) today applauds the House of Representatives for passing the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 (H.R. 6378). The legislation would re-authorize critical federal biodefense programs and agencies, including the BioShield Special Reserve Fund (SRF), the Biomedical Advanced Research and Development Authority (BARDA), and the Strategic National Stockpile (SNS).

Rare Diseases • Letters, Testimony & Comments • September 25, 2018

BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Slowly Progressive, Low-Prevalence Rare Diseases with Substrate Deposition that Results from Single Enzyme Defects: Providing Evidence of Effectiveness for Replacement or Corrective Therapies. It’s important to support and advance drug development for individuals with rare diseases. BIO suggests the FDA eliminate the phrase “low-prevalence rare disease” from the guidance.

Letters, Testimony & Comments • September 21, 2018

BIO submitted comments for the Food and Drug Administration (FDA) public hearing on Facilitating Competition and Innovation in the Biological Products Marketplace, which took place on September 4, 2018. BIO remarked on the need to foster a robust, competitive marketplace for biological products to improve patient access to safe, effective, and affordable therapies. BIO unequivocally believes that safe and effective biosimilars and interchangeable products are good for patients and good for public health. BIO's detailed comments cover topics as they relate to the biosimilars market including interchangeability, analysis of analytical similarity, patented and unpatented uses, regulatory exclusivity, and the Purple Book.