BioWorld International Correspondent
WASHINGTON - The FDA will update its regulations in a bid to reduce the time taken to get a drug approved by 10 percent or more, cutting the total investment needed to develop a new treatment by $12 million, FDA Commissioner Mark McClellan told delegates at the BIO 2003 Convention last week.
He also promised an overhaul of GMP regulations, which have remained unchanged for 25 years. New standards will be designed to foster the introduction of cost-cutting technologies into manufacturing.
At the same time postmarket monitoring will be improved by setting up an electronic system that allows the FDA to link into medical records in real time, or near real time, and monitor for signals, such as trends in blood tests, indicating a potential problem with a new medication.
McClellan told his audience, "There is no more critical time than now to address these problems."
The potential benefits of biological medicines seem greater than ever, but at the same time it appears the process of medical innovation is becoming both more costly and less certain.
The cost of developing a new drug doubled in the past 10 years, while improvements in biological science have not translated into a better success rate. "The vast majority of treatments that enter clinical testing don't succeed, and even among those products entering Phase III trials, less than half result in an application for product approval to the FDA," McClellan said.
McClellan was appointed in October, and in January set out an initiative to improve medical innovation. It includes the application of management best practice to the FDA's review procedures, and the development of new guidance documents to bring more efficiency and predictability to the regulatory process. Those will include guidance on development pathways for new technologies such as pharmacogenomics, novel drug delivery systems, and cell and gene therapy.
McClellan promised that all the objectives in the initiative will be completed "within the next few years, and in many cases, within a matter of months."
The FDA will announce shortly some specific new performance commitments to improve innovation, including the target of reducing total review times by 10 percent or more for the first 50 percent of applications approved among those submitted in a year.
"We will do more than ever to help avoid multiple cycles of review and to increase the likelihood that an application to the FDA gets it right the first time," said McClellan.
Another initiative to cut costs is an overhaul of the way medical products are manufactured. In the 25 years since GMP regulations for drugs were changed there have been significant advances in manufacturing processes that can cut impurities and inaccuracies in production. "The new standards are being designed to encourage cost-reducing and precision-enhancing innovation in manufacturing," McClellan said.
On postmarket monitoring, McClellan told delegates, "The truth is that countless adverse events go unreported." Setting up an electronic monitoring process will give the FDA more confidence during the review process that problems can be identified and communicated to doctors and patients quickly after a drug is approved, he said.