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By Antoinette F. Konski, Partner, Foley and Lardner LLP
[Editor's Note: This article first appeared October 5, 2011, on the Personalized Medicine Bulletin. Permission to republish has been granted by Foley and Lardner.]
Recently, the FDA issued a report, Driving Biomedical Innovation: Initiatives to Improve Products for Patients ("Report"), which outlines proactive initiatives to promote science and innovation to meet today's and the future's health care challenges. The Report notes that because of its role as both a regulator and a public health agency facilitating the development of new and innovative products, the FDA has a unique perspective on the health of the biomedical industry. The Report acknowledges that while the quality of the submissions for new health care products has increased in the last few years, the number of new innovative products has decreased. Last year the FDA received the lowest number of applications for novel drugs in nearly two decades.
The Report highlights 7 areas for growth and improvement:
1. Rebuilding FDA's Small Business Outreach Services
The Report recognizes that small biomedical companies possess a unique set of needs as compared to their larger counterparts. They must raise capital to fund operations and lack the regulatory experience to navigate the complexities of the FDA approval process. In addition, the absence of a business background on the part of the FDA staff is a barrier to effectively assist small business with the approval process. To the end of facilitating small business needs, the FDA will establish a Small Business Liaison program and Young Entrepreneurs program, and set up a partnership with the Small Business Administration. The FDA will offer fellowships for business, engineering, and science students, as part of their educational program, to provide them first hand access to information about regulatory review and what it takes to move a product through the FDA approval process.
2. Building the Infrastructure to Drive and Support Personalized Medicine
The Report acknowledges while personalized medicine has the potential to streamline the approval process and provide targeted therapies for individual patients, much of the applied regulatory science for evaluating strategies and outcomes for personalized medicine, such as standards for whole genome sequencing, fully qualified biomarkers, and innovative clinical trial designs and statistics, are still underdeveloped. The Report indicates that the FDA is developing a series of regulatory policies and procedures to translate personalized medicine from the microscope to the marketplace. As part of this initiative, the FDA will continue to invest in these areas and collaborate with the NIH. The FDA will also develop a draft guidance outlining strategies for clinical trial design and regulatory considerations for co-developing a novel companion diagnostic and therapy simultaneously, where the approval and subsequent use of the therapy would incorporate a requirement for the diagnostic test. A Deputy Commissioner for Medical Products will also be appointed to coordinate approvals for products incorporating diagnostics as a requirement for therapy.
3. Expedited Drug Development Pathway
The FDA recognizes that sometimes during the development of a new drug to treat a disease or life-threatening disease that has few therapeutic options, the new treatment performs much better than standard-of-care in early trials. These drugs should be developed quickly and the FDA will seek to develop an expedited drug pathway for these promising therapies. The FDA also is developing a draft guidance on enrichment strategies in clinical trial development as well as a draft guidance on the use of a pathologic complete response - when no clinical evidence of a disease remains - as a surrogate endpoint for accelerated approval in primary high-risk breast cancer.
4. Harnessing the Potential of Data Mining and Information Sharing
The FDA is currently rebuilding its IT and data analytic capabilities to harness and exploit its large repository of clinical data. The hope is that the data the FDA possesses will allow the development of new targeted therapies and reduce the overall cost of drug development. The ability of companies to share information should avoid duplication of failures the FDA sees from multiple companies for the same or similar products. The Report also indicates that the FDA is currently developing the policies, standards, infrastructure, and tools for clinical study data to enable analysis across multiple studies. Within this structure, the FDA has launched the Partnerships in Comparative Effectiveness Science (PACES) program to support the development of new mathematical methods to support patient-centered outcomes research. The FDA is also creating a framework for building collaborative scientific computing communities through public-private partnerships which will incorporate multiple medical product development companies.
5. The Future of Medical Devices
To assist medical device innovators, the FDA is seeking to improve the predictability, consistency, and transparency of its premarket review programs. Following collaboration with the medical device community, the Report indicates that the FDA is moving forward with several new actions through the CDRH Medical Device Innovation Initiative to help accelerate and reduce the time and cost of development, assessment, and review of innovative medical devices.
For example, the Report highlights a newly created expedited review program called the Innovation Pathway that will provide a more streamlined pathway to market for technologies. Moreover, to improve consistency between review teams for medical devices, all new FDA reviewers are required to participate in a Reviewer Certification Program.
6. Training the Next Generation of Innovators
A new Future Innovators Programs is planned, to bring practical regulatory science and policy training to meet the scientific and technological demands of the next century. Under this program, the FDA will hire qualified individuals for short-term positions within the FDA.
7. Improving FDA Regulations
Based on feedback from the industry and academia and other stakeholders, and under the direction of the Commissioner, the FDA is currently reviewing its regulations to identify burdensome, unclear, obsolete, or ineffective regulations.
The Report clearly shows a commitment to easing the financial burden and uncertainty innovators face within the present regulatory climate. The FDA's willingness to partner with industry and academia to improve the regulatory process should also be commended. While ambitious, the Report indicates the FDA is listening to industry and working to harness the power and potential of today's technologies.
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