New Drug Regulations Overhauled
The government published regulations Friday that it said will get new drugs to the market faster and improve monitoring of their safety.
“American consumers are the chief beneficiaries of the new regulations, because beneficial drugs will be marketed and available sooner,” Health and Human Services Secretary Margaret M. Heckler said in a statement.
Heckler, who announced the new rules when she signed them in December, called them the most extensive overhaul of Food and Drug Administration regulations in more than 20 years.
The rules were published in the Federal Register on Friday. Most of their requirements take effect in 90 days, but some include up to a year’s phase-in.
Shorter Approval Time
The government said the time required for new drug approval, currently about two years, would be cut by about six months under the new rules. Significant new drugs, which already are given priority consideration, would be least affected.
The rules require manufacturers to tell the government of any serious side effects they learn of while their drugs are being considered for marketing approval by FDA. The rules also require faster and more frequent reports on side effect problems after a drug has been approved.
The rules will reduce paper work by as much as 70% for new drug applications, which average 100,000 pages, the government said.
The rules let the FDA approve new drugs based on tests conducted in some foreign countries, and speed resolution of differences between government and drug makers, the government said.