Drug makers aim to hasten drug approval process

BOSTON —The Food and Drug Administration’s review time for new drugs has declined in recent years, yet the development of new drugs still takes eight years.

A study by the Tufts University Center for the Study of Drug Development released early last month, titled “Outlook 2009,” indicated that despite a review process that declined by 1.1 years between 2005 and 2007, the complexity of new diseases for which drug makers develop medicines has increased clinical development times and thus offset the accelerated review.

“Even though the total time to bring new drugs to market has remained essentially unchanged in recent years, drug developers are making progress,” CSDD director Kenneth Kaitin said. “Many factors are leading to longer clinical times, including a focus on complex diseases and more complicated development design protocols.”

According to the Pharmaceutical Research and Manufacturers of America, the average drug on the market is the end result of 15 years of research and development from the earliest stages of drug discovery to FDA approval. The last phase of development before a drug receives FDA approval, phase 3 clinical trials, typically includes thousands of patients at several research centers.

Kaitin said that drug companies have sought to speed development by improving project management, expanding use of partnerships and licensing arrangements, and increasing surrogate endpoints and adaptive clinical trials.

But other trends also could slow down the approval process. In particular, a shortage of experienced personnel, especially among upper-level management staff, and vacancies in advisory committees resulting from conflicts of interest and public disclosure rules could hamper the FDA’s ability to fulfill its mandate.

Still, as cost and time for research and development increase, drug companies will likely continue to partner, outsource and in-source to improve productivity, according to the report. They are likely to continue globalization of preclinical and clinical development to overcome local capacity constraints and increase the speed at which drugs make it to market, as India-based generic drug maker Ranbaxy Labs has done with phase 3 trials for the malaria treatment arterolane maleate and piper-aquine phosphate, announced in November and set to take place in Asia and Africa. Companies also may increase their use of services from contract research organizations, which the report predicted would grow by 15% a year.

But as the development time for new drugs appears likely to increase, so will the number of biotech drugs called monoclonal antibodies. The FDA has approved 22 mAbs for the U.S. market, and more than 200 are in the pipeline worldwide. These include Dutch biotech firm Crucell’s experimental flu vaccine CR6261 and bapineuzumab, an Alzheimer’s disease treatment by Elan Corp. and Wyeth in phase 3 trials set to end later this year.

This string of new antibodies could create a lot of opportunities for large drug companies looking to acquire biotech firms. In November, Indianapolis-based Eli Lilly & Co. acquired ImClone, developer of Erbitux (cetuximab).