Washington, DC, December 12, 2013 – Today, the House Committee on Oversight & Government Reform, Subcommittee on Energy Policy, Health Care & Entitlements held a hearing entitled, “FDA Check-Up: Drug Development and Manufacturing Challenges.” Paul Hastings, Chairman and Chief Executive Officer of California-based OncoMed Pharmaceuticals and Chairman of BIO’s Emerging Companies Section Governing Board, presented testimony at the hearing emphasizing the positive indicators that demonstrate the biopharma industry is rebounding, but significant financial and regulatory challenges remain.
Hastings highlighted the need to advance the regulatory environment so that it fosters biopharma innovation. Among his recommendations, Hastings emphasized the need to eliminate the sequestration of industry user fees and expedite drug development for serious and life-threatening diseases by expanding the existing Accelerated Approval pathway and by facilitating the new Breakthrough Therapy Designation process. Furthermore, Hastings asserted that encouraging scientific dialogue and interactive FDA-sponsor communication and incorporating patient perspectives in balancing benefits and risks are critically important to the drug development and review process.
Excerpts from the testimony are below, and can be attributed directly to Paul Hastings:
“Key provisions of PDUFA V and FDASIA, if implemented successfully, could significantly improve the efficiency and effectiveness of clinical development of innovative drugs by increasing scientific dialogue and enabling the utilization of modern tools and approaches to drug development.
“In addition to the primary mission of developing and providing new medicines and improving the lives of patients, the biopharma industry is and will be an important sector in a 21st century innovation driven U.S. economy.
“This year we have seen positive signs that the biotechnology industry is recovering from the economic crisis of 2007 and 2008, but the financial and regulatory environment continues to pose significant challenges to innovative drug and biologic developers.
“Our industry faces intense competition from other countries, as well as increasing R&D costs, regulatory challenges, and a contracted funding environment. It is vital that policies protect the intellectual property of these companies as any weakening of those protections will have deleterious impact on the ability to attract the necessary and long-term investment required to research, develop and ultimately make new medicines available to the public.
“I have over 27 years of experience in the biopharmaceutical industry. At OncoMed, we are at the cutting edge of oncology research. The biopharma industry is working on treatments and therapies that have the potential to deliver new solutions to our most pressing health care needs and is a key element of an innovation-driven economy.
“By harnessing the power of molecular biology and genomics, we have come a long way in turning incurable diseases to treatable diseases, increasing the ability of patients to be independent, and improving the quality of lives for many patients suffering from chronic and life-threatening diseases. Improving the quality of life, decreasing hospitalizations and allowing patients to live longer, more independent lives is not only a public health goal – it is a national imperative.”
The full written testimony can be accessed here, and a guest blog post by Paul Hastings can be found here. For more information on the latest advancements and policies impacting the biotech industry, please visit www.bio.org.