The Food and Drug Administration (FDA) released a statement today on its plan to assure American’s have access to safe and effective drugs and biologics. The plan entails modernizing the functions of the Office of New Drugs to align organizational operations with advances in science and medicine. Moreover, the proposed modernization of FDA’s Drug Review Office is a strategy to ensure alignment between innovation and regulation.The Food and Drug Administration released its plan to provide American's with access to safe and effective drugs and biologics. Click To Tweet
With this progress comes more complexity. Not only challenges related to the science of how drugs are discovered, but also the manner in which they’re developed. For very novel drugs targeting unmet needs, this often doesn’t follow the traditional three phases of clinical trials.
The Office of New Drugs
The Office of New Drugs is a division within the FDA’s Center for Drug Evaluation and Research (CDER). To help the FDA meet its public health goals, the Office of New Drugs is responsible for:
- Reviewing applications and deciding if drugs and biologics meet safety and efficacy standards;
- Setting guidance and policy to ensure efficient drug review processes;
- Overseeing investigational studies during drug development;
- Determining marketing approvals for new innovator or non-generic drugs — and making decisions related to products already in the market;
- Providing guidance to industry on clinical, scientific, and regulatory matters;
- Overseeing the 21st Century Review Initiative;
- Regulating over the counter drugs (OTC) and drug labeling; and
- Maintaining and updating databases containing information about drug shortages, post-market studies, clinical trials, generic drugs, OTC drugs, and biological therapeutic products.
Click here for more on the Office of New Drugs.
Proposed Modernization of FDA’s Drug Review Office
The FDA’s proposed modernization efforts include structural changes and process revisions.
The FDA has introduced many fundamental advances in how it evaluates drugs for safety and effectiveness, as well as the manner in which clinical trials are guided. These include adaptive approaches to clinical development such as the introduction of seamless trial designs or master protocols or tissue agnostic product approvals.
Dr. Janet Woodcock, Director of the CDER, has set goals and proposed new steps to modernize the organization and functions of CDER’s Office of New Drugs. The stated goals and proposed steps include:
- Issuing more product-specific guidance documents. The plan is to develop hundreds of new clinical guidance documents and make sure they stay up-to-date to reflect the latest science;
- Implementing new organizational structures to allow review staff to have more time for reviewing and providing feedback to sponsors on clinical protocols;
- Engaging sponsors earlier in the development process to ensure that trial designs are efficient and structured in the most effective way to identify risks and measure outcomes;
- Expanding the Office’s ability to engage external stakeholders, such as disease specialists, academic researchers, external regulatory partners, and patient groups. Patient-focused drug development is becoming an industry trend;
- Creating many new therapeutic-specific divisions that will have more ability to engage in discrete areas of medicine; and
- Better organizing the entire review process and the development of the key review memos to enable medical staff to efficiently document their findings. This will allow medical staff to spend more of their time on advancing scientific work in their fields and less time documenting and performing administrative tasks.
We believe the new alignment and processes will improve efficiency by 20 percent at a minimum overall […] We’ll engage the external community more closely in our work, especially patients who inform our patient-focused drug development, with the aim of advancing more modern regulatory principles.
Ultimately, the proposed modernization of the FDA’s Drug Review Office is an attempt to:
- Ensure the organizational structure consistently follows the subdivisions of medicine;
- Streamline processes to enhance operational efficiencies and communication flows;
- Assure American’s have access to safe and effective drugs and biologics; and
- Achieve alignment between innovation and regulation.