Educate, Engage, Empower
Throughout BioOhio’s 34-year history, the organization has worked with local, state, and federal agencies, officials, and representatives to promote Ohio’s bioscience industry, BioOhio members, and the health and prosperity of Ohio.
BioOhio serves as the Ohio affiliate of national industry groups Advanced Medical Technology Association (AdvaMed), Biotechnology Innovation Organization (BIO), Medical Device and Manufacturing Association (MDMA), and Pharmaceutical Research and Manufacturers of America (PhRMA).
If you would like to get involved or have questions about these issues, please contact a BioOhio team member.
Current State Policy, Issues, and Opportunities
The following are selected key areas of focus for BioOhio, our partners, and members. Click here to review additional content and past activity at the State level. Use the links below for direct access to press releases, bill text, status, and testimony from proponents, opponents, and other interested parties.
• Essential Workers and Vaccinations (2/1/2021) – BioOhio, along with its national partner BIO, has asked Governor DeWine to consider certain bioscience industry personnel who reside and/or work in our state to be considered as essential workers slated to receive a COVID-19 vaccine during the early phases of immunization. Read the full letter here (pdf).
• HB 469 Accumulator Adjustment Policy Reform Legislation: State Reps. Thomas E. West (D-Canton) and Susan Manchester (R-Waynesfield) co-sponsored House Bill 469, which will cut out-of-pocket prescription costs for patients. BioOhio signed onto several support letters in 2020 along with 50+ supporters of this legislation including BIO and PhRMA.
• HB 412 Rare Disease Advisory Council: State Reps. Randi Clites (D-Ravenna) and Tim Ginter (R-Salem) co-sponsored House Bill 412, bipartisan legislation that will create the Ohio Rare Disease Advisory Council. BioOhio was written into legislation to participate in the Council and has submitted testimony in July 2020. This Council is officially endorsed by BIO and PhRMA.
• InnovateOhio: Under the leadership of Lt. Governor Jon Husted, InnovateOhio is advancing the DeWine Administration’s commitment to leading an aggressive, innovative path towards a better and stronger Ohio.
• HB 166 Prescription Drug Transparency and Affordability Advisory Council: The Council is tasked with providing recommendations to the General Assembly, Governor DeWine, and the Joint Medicaid Oversight Committee regarding Ohio’s best path forward for issues such as prescription drug price transparency, affordable payment models, and health care efficiency.
Current Federal Policy, Issues, and Opportunities
The following are selected key areas of focus for BioOhio, our partners, and members. Click here to review additional content and past activity at the Federal level. Use the links below for direct access to press releases, bill text, status, and testimony from proponents, opponents, and other interested parties.
• COVID-19 Relief Legislation: Congressional lawmakers have been debating the substance of a 5th legislative package to help the country weather the health and economic effects of the COVID-19 pandemic. Negotiations have spanned several months, stalling at times over disagreements surrounding unemployment insurance benefits and aid to state and local governments. This, combined with a rapidly approaching Presidential election and a potential Supreme Court confirmation process, has reduced the chances of a 5th COVID stimulus deal being reached until at least after the Nov. 3rd election.
• Medical Device User Fee Amendments: Device user fees were first established in 2002 by the Medical Device User Fee and Modernization Act (MDUFMA). Under the user fee system, medical device companies pay fees to the FDA when they register their establishments, list their devices with the agency, submit an application or notification to market a new medical device in the U.S., and for certain other types of submissions. The U.S. Food and Drug Administration is required to incorporate public input on this fee amendment decision-making process and does so through regular public hearings. Current fee amendments will be in place from Oct. 1, 2017, until Sept. 30, 2022. New legislation is required for the FDA to continue to collect user fees for the medical device program in future fiscal years.
• Buy American & Reshoring: A presidential election issue, following shortages of personal protective equipment (PPE) and critical medical supplies due to COVID-19, policy proposals have been brought forth to “reshore” U.S. medical and PPE supply chains. Depending on the specific language of the policy proposal, of which various versions have been recently introduced by congressional lawmakers, this policy could create unintended consequences, ultimately burdening Ohio’s bioscience and pharmaceutical industries if improperly enacted.
• International Pricing Index: President Trump has issued executive orders addressing the price of prescription drugs. While these orders take aim at significant issues faced by consumers of prescription drugs, certain provisions of these and other related policies may inhibit future biomedical and pharmaceutical innovation throughout the commercialization process. National-level organizations as well as state bioscience chapters are carefully monitoring the execution and implementation of these orders.
• CMS Breakthrough Pathways: The Centers for Medicare & Medicaid Services (CMS) recently released its long-awaited proposed rule on “Medicare Coverage of Innovative Technologies.” The proposed rule would make significant changes to streamline Medicare coverage for FDA-designated breakthrough technologies that have market authorization. The rule would create a new, voluntary Medicare Coverage of Innovative Technologies (MCIT) pathway that would provide immediate, national Medicare coverage of any FDA-market authorized breakthrough device if the device meets certain criteria. This automatic coverage would begin on the date of FDA-market authorization and would last for four years, after which time coverage would be determined through existing processes. This proposed rule is the result of years of advocacy on the part of national-level organizations such as AdvaMed and its member companies, who are generally supportive of the policies included in the measure. Supportive legislation has been introduced in the House and Senate that would be complementary to this CMS decision. Sen. McSally has introduced S.3914, the Ensuring Patient Access to Critical Breakthrough Products Act of 2020. Rep. Suzan DelBene is thought soon to carry this, as she has introduced this legislation before.
• Verifying Accurate, Leading-edge IVCT Development (VALID): This legislation would modernize the critical framework that the U.S. FDA uses for regulatory oversight over certain diagnostics, including laboratory-developed tests (LDTs) and in-vitro diagnostics (IVDs), in a risk-based manner that provides vital assurances to the public for accurate and high-quality testing. This bill would help ensure the healthcare industry keep pace with scientific progress in the field and would foster overall innovation. This risk-based framework brings together essential reforms for all diagnostics and is vitally important to ensure a consistent and predictable pathway for developers as well as timely patient access to cutting-edge diagnostic technologies. National-level industry organizations such as AdvaMed have testified in support of this policy proposal. This legislation has been introduced in the House and Senate by Rep. Diana DeGette (D-CO-1) and Sen. Richard Burr (R-NC) respectively.
• Medical Supply Transparency and Delivery Act: This legislation would require the president to utilize all available authorities under the Defense Production Act to mobilize a federal response to the pandemic through an equitable and transparent process. Companions bills were introduced in the House and Senate by Rep. Jason Crow (D-CO-06) and Sen. Tammy Baldwin (D-WI). While this legislation is not anticipated to gain momentum in the 116th Congress, national-level organizations such as AdvaMed and state bioscience chapters are closely following this legislation.
On the forefront of furthering lifesaving, landmark innovation, the biotechnology industry promises to continue to heal, fuel and feed the world. Learn about the key issues facing our biotechnology sectors, and how to get involved and share your biotechnology story with BIOAction.