FDA Plans to Spend as Much as $50M on Regulatory Science, With Focus on Generics

The US Food and Drug Administration (FDA) has released its latest "Broad Agency Announcement" detailing the areas to which it hopes to direct funding in the coming year in order to solve or alleviate some of its most pressing regulatory needs.

Like FDA's 2013 Broad Agency Announcement, the 2014 announcement says FDA is prepared to spend—"subject to congressional appropriations"—as much as $50 million on meeting nine overarching goals and dozens of sub-level interests. A brief overview of those areas is as follows:

1. Modernize toxicology to enhance product safety

a. Develop better models of human adverse response

b. Identify and evaluate biomarkers and endpoints that can be used in non-clinical and clinical evaluations

c. Use and develop computational methods and in silico modeling

d. Develop better models to investigate the toxicology of veterinary drugs

2. Stimulate innovation in clinical evaluations and personalized medicine to improve product development and patient outcomes

a. Develop and refine clinical trial designs, endpoints and analysis methods

b. Leverage existing and future clinical trial data

c. Identify and qualify biomarkers and study endpoints

3. Support new approaches to improve product manufacturing and quality

a. Enable development and evaluation of novel and improved manufacturing methods

b. Develop new analytical methods

c. Reduce risk of microbial contamination of products

d. Improve scientific approaches to evaluate generic drugs

e. Identify and qualify pain-associated biomarkers that are associated with therapeutic Control of pain in food producing animals

f.  Develop a regulatory database for species identification

4. Ensure FDA readiness to evaluate innovative emerging technologies

a. Develop assessment tools for novel therapies

5. Harness diverse data through information sciences to improve health outcomes

a. Develop and apply simulation models for product life cycles, risk assessment, and other regulatory science uses

b. Analyze large scale clinical and preclinical data sets

c. Computer modeling and simulation to assess product risk

6. Implement a new prevention-focused food safety system to protect public health

a. Establish and implement centralized planning and performance measurement processes

b. Enable intelligence-driven, risk-based targeted inspections

7. Facilitate development of medical countermeasures to protect against threats to US and global health and security

a. Develop, characterize, and qualify animal models for MCM development

b. Modernize tools to evaluate MCM product safety, efficacy, and quality

c. Develop and qualify biomarkers of diseases or conditions

d. Enhance emergency communication

8. Strengthening social and behavioral science at FDA by enhancing audience understanding

a. Assessment of how communications are understood, especially among diverse audiences and populations, and methods to improve the comprehension of content, including numerical information

b. Exploration of how FDA communications can best complement those produced by industry to enhance audience comprehension

c. Research to assess public understanding of the regulatory terms in use

d. Evaluation of timing of release of recall or warning messages, when the messages should be changed to enhance impact, and how to communicate the end of a recall or warning

e. Studies to increase the safety of post approval drug use

9. Strengthening the global product safety net

a. Advancing global public health

b. Leveraging and collaborating

c. Analyzing and utilizing global data to manage risks

d. Manage risks related to intentional disruptions to food supply

Focus on Generic Drugs

Of interest in the announcement is how much space is devoted to the evaluation of generic drugs—an area that has received a growing amount of interest in recent years owing to quality problems at generic drug manufacturing sites and bioequivalence problems in some major drugs.

FDA's announcement notes that as part of its commitment under the 2012 Generic Drug User Fee Amendments, it plans to conduct research "Designed to enhance public access to safe, high-quality generic drugs and to reduce costs to industry."

FDA says it plans to initiate at least one study of how to better "Evaluate and verify therapeutic equivalence" using "generic switching studies.” Among the drugs to be studied are some with known problems (anti-epileptic drugs and bupropion), as well as some with lesser-known problems like ADHD drugs, cardiovascular drugs and immunosuppressant drugs.

FDA said it also plans to develop therapeutic equivalence evaluation and standards for narrow therapeutic index (NTI) drugs and investigate factors that may have an effect on equivalence, such as tablet size.

Several other studies are also planned.

Broad Agency Announcement