Generic drugs online

Source: Reuters

Date: 25-Feb-2010

Author: Lucas Jackson, Cynthia Osterman

With an aim of getting experimental new drugs to people quicker, the U.S. Food and Drug Administration and National Institutes of Health announced a plan on Wednesday to work more closely together.

Under the new arrangement, the NIH will better design some of its basic research so that potential new drugs can get into the FDA approval process more quickly, the agencies said.

"This is a significant bringing together of two major agencies in the government that have different but complementary roles to play in terms of speeding up treatments," NIH director Dr. Francis Collins said in a telephone interview.

Both NIH, which conducts and funds medical research, and the FDA, which regulates some food and most drugs, fall under the Department of Health and Human Services.

"We've all been following the remarkable advances in biomedical sciences led by the NIH with great enthusiasm for years," HHS Secretary Kathleen Sebelius said in a statement.

"However, much more can be done to speed the progress from new scientific discoveries to treatments for patients. Collaboration between NIH and FDA, including support for regulatory science, will go a long way toward fostering access to the safest and most effective therapies for the American people."

NIH often does the ground-floor research that leads to the eventual development of drugs. NIH researchers discovered that Pacific yew trees could yield a compound used to make Taxol and related cancer chemotherapy drugs, for instance.

REGULATORY NEEDS

But Collins said this research is rarely done with an eye to meeting the needs of the FDA, which must decide if a drug can be tested in people and whether, once it has, it is safe and effective.

"You can have all of that vast scientific planning in the world (but) if you have not thought carefully about the data that the regulators are going to need and the study design you should have adopted, you will just have to start over again," Collins said.

The two agencies will establish a joint leadership council to do this.

"In addition, the NIH and the FDA will jointly issue a request for applications, making $6.75 million dollars available over three years for work in regulatory science," they said in a joint statement.

Collins said the NIH may do more to bring drugs to market itself but will also continue to work closely with biotechnology and pharmaceutical companies. Usually, the NIH does the ground-floor work and licenses the most promising compounds to a company for further development.

Collins said he and the new FDA commissioner, Dr. Margaret Hamburg, came up with the idea soon after both were appointed by President Barack Obama.