The United State’s Food and Drug Administration (FDA) created a plan to help promote improvement in the way products that are regulated by the FDA are developed, assessed, produced, and used. In March 2004, a program was initiated through a report released by the FDA called, Innovation/Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products. The report explained why there was a disconnect between important scientific breakthroughs that had the capability of preventing and curing some of the most deadly diseases and their ability to actually be used in the medical field.
The publication recommended that there be a combined national effort to update both scientific and technical resources that would simplify the entire process from the use of technology to creation, evaluation, and approval of new medical products.
In 2006 a list was released called, FDA’s Critical Path Opportunities List. It outlined areas where improvement was needed most in medical product development. The topics listed as critical include the following:
- development of improved evaluation tools
- streamline clinical trials
- use bioinformatics science
- update manufacturing process and procedures for the 21st Century
- produce products that help “urgent” public health needs
- address “at-risk” populations (Pediatrics)
The publication listed 76 actual examples where scientific breakthroughs could be used in the development process to help with testing accuracy when evaluating safety and effectiveness of prospective medical products. The list was a catalyst for many new projects that were put into place as part of the Critical Path Initiative during 2006 and 2007.
Critical Path Initiative – Innovation as a National Strategy
CPI resulted in concentration of improving tools and processes in the 21st century in areas such as medicine, food, and treatment methods. The number of projects for innovation grew from just 40 in 2006 to 95 in 2009 as a result of the CPI. The FDA began working more closely with other agencies, researchers, industries, and patient groups in areas such as development, solution distribution in scientific challenges, evaluation, and efficiency to improve the process for products regulated by the FDA. Details regarding innovation activities prompted by CPI can be found in a document titled, Critical Path Opportunities Initiated During 2006 posted on the FDA website.
New information is posted as new projects are added.
The CPI is one of the FDA‘s top priorities in the 21st century so that they can help move scientific advances forward to improve health treatments in America.
Critical Path Initiative in the 21st Century
The CPI continues to gradually take advantage of emerging technologies and new scientific discoveries to improve tools used by the FDA for evaluation of products.
Some examples of this are in the evaluation of food, food ingredients, and veterinary products, such as rapid testing that establishes whether or not there is chemical or biological contamination in foods derived from animals. Other new technologies such as cloning and genetically engineered animals and plants are presenting new obstacles to the field of veterinary medicine that need to be evaluated from a cross-disciplinary perspective. This reinforces the importance of collaborative efforts by partners in the medical field.
Another example is the CPI‘s use of bioinformatics, a science that combines the use of biology and information technology to analyze biological information. This approach is making it possible to put essential information systems into place that play a key role in boosting innovation and public safety in the medical field.
The report titled, Projects Receiving Critical Path Support in Fiscal Year 2008, released by the FDA in April 2009, highlights projects being undertaken by the FDA and its collaborative partners in their push toward designing and putting into place a more fully-integrated and flexible electronic infrastructure that makes it possible to send, receive, and manage data regarding FDA-related products in a “real time” environment. This will simplify data tracking for products and assist in areas such as tracing contamination of human or animal food, and in reporting other adverse findings.
These actions and projects are part of the overall CPI plan to assist the FDA with its move toward innovation that will improve the agency’s methods of monitoring foods and drugs, and instituting new treatments.
Reasons for Establishment of the Critical Path Initiative
The lack of innovative products being presented to the FDA for use in the medical field (due to a gap between scientific research and product creation and testing) was the primary catalyst for the development of the Critical Path Initiative.
Data collected showed that even though research time and development increased by 250 percent over a ten-year period, the number of new products presented to the FDA for approval had declined over the same period of time. The irony is that although the FDA review period has been shortened significantly, as compared to past years when review periods typically lasted on an average of 40 months, the process still generates low numbers of products.
The reasons given to explain the decline in approved products were outdated testing methods during the development phase and increased failure rates during the testing phase. It was deduced that product developers were using outdated tools and methods to evaluate innovative products. The FDA concluded that there had to be a conscious effort made to get regulators, academia, and industry to work collaboratively to improve medical product development processes and methods.
Creation of the Critical Path Institute
The Critical Path Institute, also known as C-Path, is a non-profit, independent organization that was founded in 2005 to help support the FDA‘s Critical Path Initiative. The institute uses an approach to drug innovation that is based on three basic tenets, “faster, safer, smarter.” The institute ensures that the Critical Path Initiative objectives are carried out. These objectives include modernizing the scientific development and testing methods and procedures so that medicines and other medical resources are available to the public in a timely manner.