By Nancy Chew
Most people who work in the pharmaceutical industry know that drug development comprises of pharmaceutical development, animal pharmacology and toxicology studies, and clinical research; many also know that there are quality standards applied to manufacturing and controls that become more and more stringent as the development process evolves. Similarly, the quality standards for animal pharmacology, safety pharmacology and toxicology are implemented in a tiered manner. Clinical research, the most time consuming and costly part of the process, is also controlled by quality practices.
Many more drugs fail during development than make it to market. The Pharmaceutical Research and Manufacturers of America estimates that it requires more than 10 years and $2.6 billion dollars for a drug to be approved for marketing. And only 12% of drugs that enter the development process make it to market. The discovery of clinical lead compounds requires many more potential drugs to be discarded prior to IND development.
This means that FDA holds many more pre-IND meetings than end-of phase 2 or pre-NDA meetings.
Many people hold that “regulatory efficiency” is an oxymoron. The only efficient path to market is to do it right in the first place. FDA provides consultation to pharmaceutical manufacturers throughout the development process. Using the opportunities offered by standard development, pre-IND, end of Phase 2, and pre-NDA meetings with the agency gives sponsors access to the wealth of information FDA has gained from review of previous applications as well as up-to-the minute advice on how to comply with current regulations and standards. There are published guidance documents on how to prepare for and hold these meetings; however, often, a sponsor requires the assistance of consultants who are experts in the various aspects of development that pertain directly to their product (e.g. a new nanotech formulation). Most sponsors also benefit from the assistance of regulatory experts for defining the topics and detailed questions to discuss, preparation of documents, regulatory protocol, and the conduct of the meeting itself.
Today, global drug development is coordinated mainly through the International Conference on Harmonization (ICH) process. The beauty of this system is that when a drug is developed according to ICH Guidelines, the research portfolio will be accepted in all the countries that have incorporated those guidelines into their own regulatory system. For example, the group of toxicology studies required before starting clinical studies is agreed and accepted by all the countries that participate in this process. This allows one body of technical information to be accepted by health regulatory authorities in Europe, Japan, Canada and many other countries.
Because the development of a novel compound into a marketable drug is so costly and time consuming, other regulatory routes to market are available. Perhaps the best known is the Abbreviated New Drug Application, a copy of a previously approved drug, which is available after all patents and marketing exclusivity options have expired. Recently, the 505(b)(2) process has become a popular means of short-circuiting part of the drug development process; it relies, as does the ANDA process, on FDA’s previous finding of Safety and Effectiveness for a drug product.
In summary, this brief overview illustrates that there is no simple route when introducing a new drug and there is more than one possible path to success.