Modernizing the New Drugs Regulatory Program

In 2017, the FDA’s CDER (Center for Drug Evaluation and Research) Department instituted a modernization initiative for its “New Drugs Regulatory Program (NDRP).” This modernization program:

“Is in response to a rapid increase in drug development complexity and volume in the past two decades and the anticipation of future growth — fueled in part by the recent breakthroughs in genetic science, personalized medicine advances, and a greater focus on rare diseases and disease subtypes.”

The CDER has the task of ensuring that human drugs are safe and effective for their intended purpose.

What are the aims of the New Drugs Regulatory Program?

According to the FDA’s June 24, 2024 review, the NDRP modernization initiative will help CDER by participating in the regulatory review and decision-making for “new drug products and original therapeutic biologics.” The modernization plan has six core goals:

• “Scientific Leadership. Grow our scientific expertise and clarify pathways to regulatory approval.
• Integrated Assessment. Critically, collaboratively, and consistently assess whether information in drug approval applications meets legal and regulatory requirements. [Our healthcare are lawyers can help pharmaceutical companies and healthcare providers understand these requirements].
• Operational Excellence. Standardize workflow, business processes, roles, and responsibilities to improve operational efficiency, and enable our scientists to focus on science.
• Benefit-Risk Monitoring. Systematically monitor the benefits and risks of approved drugs pre- and post-approval to effectively protect the American public.
• Managing Talent. Attract, develop, and retain outstanding people.
• Knowledge Management. “Facilitate the identification, capture, distribution, and effective use of information.”

There are also numerous strategies to achieve these objectives. These strategies include:

• OND (Office of New Drugs) reorganization.
• Integrated assessment of marketing applications.
• Postmarket safety.
• IND review management.
• Advisory committees.
• Assessing talent and talent development and management.
• Knowledge management.

According to CBS Reports, during the premarket (preapproval) phase, drug manufacturers cannot sell their drugs until there is FDA approval. The postmarket (post-approval) phases lasts as long as the drug is being sold.

Generally, drug manufacturers:

• Work in the laboratory and with animals to develop a prototype drug.
• The company then seeks FDA approval (through an investigational new drug (IND) application), to “test the product with human subjects.” The tests, clinical trials, involve “Phase I, II, and III studies, which involve increasing numbers of subjects.”
• The company then “compiles the resulting data and analysis in a new drug application (NDA).”
• The FDA then reviews the NDA with three major concerns:
  • “Safety and effectiveness in the drug’s proposed use
  • Appropriateness of the proposed labeling
  • Adequacy of manufacturing methods to assure the drug’s identity, strength, quality, and purity.”

Some of the accomplishments of the NDRP modernization program

One successful workstream was the creation of an “Investigational New Drug (IND) Review Management,” to help streamline the IND. The modernization program is helping to provide:

• “New review templates for IND 30-day safety and protocol and amendment reviews across all OND prescription drug divisions to improve flexibility and suitability.”
• Transition the IND 30-day safety reviews into an automated workflow system – for the purposes of efficiency, knowledge management, collaboration, and standardization.

How the modernization effort is impacting public health.

In several ways the NDRP modernization program is improving public health:

• The NDRP modernization’s Benefit-Risk Monitoring objective (described above), “identifies and evaluates risks across the lifecycle of drugs and biologics—that is, both pre- and post-approval.” Most of the benefit is “postmarket safety surveillance of drugs” after the drugs are approved and enter the market. The monitoring program helps to identify positive and negative effects that weren’t covered in the premarket clinical trial setting. There are nine “Drug Safety Teams” that help the different offices collaborate and increase postmarket safety surveillance effectiveness.
• COVID-19. The NDRP program, in 2021, was able, through its Scientific Leadership initiative (described above) to help the various CDER offices work “jointly with partners from within and outside FDA” to share their knowledge of COVID-19 treatments and help develop safe and effective COVID-19 therapies to treat and prevent COVID-19.

“These collaborations ensured that CDER provided timely advice on COVID-19 to sponsors, standardized regulatory actions across CDER, and modified trial designs to best evaluate potential therapies within the current standard of care treatment paradigm.” Other review teams helped address drug shortages of COVID-19 treatments, including tocilizumab and baricitinib.”

What does NDRP hope to accomplish in the future?

The FDA states that additional short-term goals and long-range initiatives of the NDRP modernization program include:

• New improvements based on user input to help create easier access to important product lifecycle information.
• The creation of an “Information Request (IR) focused dashboard” to help search and filter information requests.
• Exploring and evaluating new technologies.
• Improving “learning and development opportunities in the field of Postmarket Safety, such as in our “Essentials of Postmarket Drug Safety Curriculum.”

The NDRP modernization program has now become a permanent initiative.

More information about the NDRP modernization program can be found here.

The Center for Drug Evaluation (CDER) has implemented an initiative to modernize CDER’s New Drugs Regulatory Program (NDRP). Pharmaceutical companies need to understand how these modernization strategies can improve their ability to obtain premarket and postmarket approval for the drugs these companies manufacture. Pharmaceutical companies also need to understand what compliance issues may regulate their drug approval and drug monitoring process.

Pharmaceutical companies and healthcare providers who manufacture and prescribe drugs should contact Cohen Healthcare Law Group, PC to review their legal and healthcare compliance requirements. Our experienced healthcare lawyers advise medical companies, pharmacists, and physicians about compliance laws and regulations issues.