Future Plans of the FDA in the Pharmaceutical Manufacturing Industry

The main regulatory body at large in the pharmaceutical manufacturing industry is the Food and Drug Administration (FDA). The FDA sets de jure standards responsible for protecting and promoting public health through the regulation and management of food safety, pharmaceutical drugs, and many other fields relating to public health. The main body of the FDA responsible for the development and approval of drugs is the Center for Drug Evaluation and Research (CDER). The goal of CDER is to ensure that drugs marketed in the United States are safe and effective. CDER recently published a strategic plan to discuss the steps it will be taking to address pressing issues and their proposed ways of enhancing operations over the next five years. One of the main issues outlined in the plan is scientific innovation. CDER admits that not all current trends in the pharmaceutical industry are positive. “Despite the significant advances in basic research witnessed over recent decades, the cost of new drug research and development has never been greater, nor the failure rate in drug development higher” (FDA CDER). It is estimated that the failure rate in late-stage clinical development is around 50 %. One of the major, reoccurring factors contributing to this failure rate is scientific uncertainty. New methods and technologies for gauging the clinical benefits and risks of a drug much earlier in development would help reduce these uncertainties, resulting in a lower cost and risk in drug development. This would allow more innovators to invest in the development of new medicines.

One example of an area that would benefit from a reduction in scientific uncertainty is biotechnology. The pharmaceutical protein products developed by biotechnology processes are derived from complicated expression and production systems that usually involve a genetically modified host cell and growth media. Production conditions can greatly affect the final protein structure, which may result in changes in efficacy or safety of the product. “Understanding the relationships between production conditions, product characteristics, and clinical performance and safety is critical for both innovator biologics as well as biosimilars” (FDA CDER).

The foundation of CDER’s scientific innovation strategy includes addressing scientific uncertainties, collaborating to develop tools and approaches to deal with those uncertainties, qualifying new drug development tools for use in regulatory decision-making, and conducting training on and making informatics and data analysis readily available to reviewers. Once these new scientific standards are established, the FDA can update their regulatory requirements and decision protocols to include these methods. By continuously revising regulatory requirements, the FDA incorporates scientific innovation into their management strategy. All prescription and over-the-counter drug manufactures are required to comply with FDA regulations and therefore integrate scientific innovation into their business and manufacturing model.

CDER’s strategic plan also includes scientific innovation goals and initiatives, including information about when each initiative will start and identifying the key external stakeholders. For example, one of CDER’s initiatives is, “Advancing regulatory sciences related to innovator and generic product manufacturing and quality” (FDA CDER). This initiative is labeled as on-going with stakeholders in academia, regulated industry, research consortia, standards organizations, and other federal agencies. It is interested to note that several of the initiatives have standards organizations as one of the stakeholders. The FDA recognizes that some of the work it does directly affects how standards organizations like ASTM and USP developed their standards. Standard organizations need to aware of the drug approval process and quality regulations outlined by the FDA in order to ensure seamless transition from the research and development laboratory to clinical production and manufacturing. As with many scientific fields, the regulatory bodies and standards organizations of the pharmaceutical industry are interconnected and dependent on each other for proper functionality.

Table 1—CDER’s Scientific Innovation Initiatives

Scientific Innovation Initiatives	Start	Key External Stakeholders
Advancing the Use of Biomarkers and Pharmacogenomics	2013	·         Regulated Industry ·         Research Consortia
Advancing Development of Patient-Reported Outcomes (PROs) and Other Outcome Assessment Tools	2013	·         Patients ·         Research Consortia ·         Regulated Industry
Advancing Development of Drugs for Rare Diseases	2013	·         Patients ·         Research Consortia ·         Regulated Industry
Advancing the Science of Meta-Analysis Methodologies	2012	·         Other Federal Agencies ·         Regulated Industry ·         Academia
Advancing the Development of Predictive Safety Models, Biomarkers, and Assessment Tools (e.g., through public private consortia)	On-going	·         Patients ·         Research Consortia ·         Regulated Industry ·         Other Federal Agencies
Advancing Social and Behavioral Science to Help Consumers and Professionals Make Informed Decisions about Regulated Products	On-going	·         Patients ·         Research Consortia ·         Regulated Industry ·         Academia
Advancing Regulatory Sciences Related to Innovator and Generic Product Manufacturing and Quality	On-going	·         Academia ·         Regulated Industry ·         Research Consortia ·         Standards Organizations ·         Other Federal Agencies
Advancing Regulatory Science Related to the Manufacture, Characterization and Assessment of Biologic Drug Products	On-going	·         Academia ·         Regulated Industry ·         Research Consortia ·         Standards Organizations ·         Other Federal Agencies
Advancing the Development of Electronic Data Analysis Tools to Enhance Review Capabilities	On-going	·         Standards Organizations ·         Private Industry ·         Academia ·         Research Consortia ·         Other Federal Agencies

Source— FDA Center for Drug Evaluation and Research (CDER): Strategic Plan 2013-2017