Comments on OND Opportunities, Priorities
Pharmaceutical Research and Manufacturers of America (PhRMA) says it strongly supports FDA efforts to facilitate effective drug development, leveraging rapidly evolving scientific and technological advances to characterize the benefits and risks of a potential product and generate the data necessary to support product approval. Commenting on an FDA docket and public meeting on opportunities and priorities for the CDER Office of New Drugs (OND), PhRMA said it strongly supports a vision of a future new drug regulatory program paradigm that is optimized for early identification and resolution of key issues, promoting efficiencies and effectiveness in drug development, and conducive to highly productive and timely interactions between FDA and sponsors during drug development. The association said it believes that OND reorganization “will enhance and improve the efficient science-based review of new drugs and biologics, thereby expediting the availability of needed new therapies for patients.”
Pfizer provided recommendations that FDA, industry, academia, and patients can take jointly to enhance the drug development and review process, covering the development of new medicines for severely debilitating or life-threatening disorders; post-market requirements and commitment process reforms; addressing variation in the application of existing FDA guidance; and adoption of novel regulatory science tools and methods.
The Sanofi comment letter said the company believes that creating a robust, accessible, quality database of FDA regulatory actions would greatly advance drug development and regulatory decision-making.
Janssen shared its experience developing drugs in several therapeutic areas, including cardiovascular and metabolism, infectious diseases, immunology, neuroscience, oncology, and pulmonary hypertension. It discussed its experience across not only OND review divisions but also the intersection between CDER, CBER, and CDRH in hopes of improving drug development for patients.
The Biotechnology Innovation Organization (BIO) offered several specific recommendations for CDER on how to promote effective drug development programs. The association pointed out that while FDA has said that real-world evidence and patient-focused drug development are not within the scope of this topic, BIO believes they have an integral role in improving efficiencies in drug development and regulatory decision-making. It also called attention to OND’s position at the apex of review divisions, providing guidance on policy that may include real-world evidence and patient-focused drug development and thus the topics should be kept in mind.
Finally, Amgen provided its policy recommendations about innovative trial designs, using the FDA Sentinel system to evaluate drug safety issues, sharing of case examples, and increased flexibility in regulatory approaches to clinical trial endpoints.