Health and Human Services Secretary Margaret M. Heckler said she has launched an "action plan" to help implement recent regulations that speed up the process of getting new drugs on the market.
The new regulations, which took effect earlier this year, are designed to reduce the time it takes for a new drug to be approved by up to six months from the two or more years that such approval now takes.
Under the plan, drug manufacturers will be able to submit new drug applications in electronic form, establish priority reviews for drugs already on the market that are found to have other benefits, increase FDA personnel where needed, and ensure that the best scientists in the drug field continue to be available for FDA work.
New drug applications average about 100,000 pages of raw and summary data. Heckler said the new rules will cut by about 70 percent the paper work that manufacturers must submit. She said that eventually these applications will be received electronically "for better management and speedier action."
Heckler said that FDA will also establish a toll-free number to encourage physicians to report adverse reactions to new drugs directly to the FDA.
Heckler also announced that she had approved a final regulation that will give manufacturers greater freedom in the early stages of drug research to design their own studies in accordance with safety requirements.