Featured Research

from universities, journals, and other organizations

Drug approvals taking as long as ever, despite new information technology at FDA

Date:
November 19, 2009
Source:
Inderscience Publishers
Summary:
Drug approvals are taking just as long as they ever did despite increased expenditure on new information technology at the Food and drug Administration. So says a statistical analysis of approval intervals from 1997 to 2006.

Drug approvals are taking just as long as they ever did despite increased expenditure on new information technology at the Food and drug Administration. So says a statistical analysis of approval intervals from 1997 to 2006, published in the International Journal of Electronic Healthcare.

Related Articles


Since the middle of the 1990s, FDA review intervals have been an important topic of discussion for the boards of major pharmaceutical companies and among consumer groups desperate to see new, improved products on the market. The issue has been raised by economists and financiers and in Congress.

John Kros and Christopher Keller of the College of Business, at East Carolina University, in Greenville, North Carolina, explain that the implementation of new Information Technology (IT) at the FDA has been a persistent target for reducing the time taken between an application and final approval. They have analyzed data on three main categories of new drugs are studied: New Drug Application (NDA), the Supplemental New Drug Application (SNDA) and the Abbreviated New Drug Application (ANDA).

The team points out that under the 1992 Congressional Prescription Drug User Fee Act (PDUFA), drug companies agreed to pay fees to the FDA and in turn, the FDA agreed to time limits on the review process for new drug applications. Then, the FDA Modernization Act of 1997 new funds and user fees were authorized. Both changes coincided with a significant increase in the use of IT at the FDA.

However, significant increases in IT use do not seem to have translated into shorter interval times, according to the study by Kros and his team. They have found that the median review time (almost seven months) for an ANDA was significantly longer than that of an NDA and SDNA. In this study, which concludes the second part of a long-term analysis of the data, Kros and his colleagues saw no statistically significant reduction in review times.

Earlier research suggested that FDA review times decreased throughout the 1980s and into the 1990s, which was ascribed to greater resources and higher quality submissions as well as the PDUFA. However, increasing numbers of drug applications and increased concerns over drug safety, have to some extent negated the earlier gains in recent years.

"The FDA faces a balance between allocating resources between new drug reviews and the generic drug review process," the researchers say, "When more resources go to the new drugs, these new drugs can get to market faster and patients suffering from unsuccessfully treated diseases can benefit more quickly." Shorter drug review times can encourage new drug R&D, but more resources allocated to generic approvals can benefit the market and the consumer by offering more choice.

"The present research contributes a baseline for future comparison by which any future reductions in approval times which, do result from the implementation of information technology could be verified," the researchers conclude.


Story Source:

The above story is based on materials provided by Inderscience Publishers. Note: Materials may be edited for content and length.


Journal Reference:

  1. Kros et al. FDA drug approval intervals from 1997 to 2006: analysis and comparison during information technology implementation. International Journal of Electronic Healthcare, 2009; 5 (2): 164 DOI: 10.1504/IJEH.2009.029223

Cite This Page:

Inderscience Publishers. "Drug approvals taking as long as ever, despite new information technology at FDA." ScienceDaily. ScienceDaily, 19 November 2009. <www.sciencedaily.com/releases/2009/11/091119101044.htm>.
Inderscience Publishers. (2009, November 19). Drug approvals taking as long as ever, despite new information technology at FDA. ScienceDaily. Retrieved March 29, 2015 from www.sciencedaily.com/releases/2009/11/091119101044.htm
Inderscience Publishers. "Drug approvals taking as long as ever, despite new information technology at FDA." ScienceDaily. www.sciencedaily.com/releases/2009/11/091119101044.htm (accessed March 29, 2015).

Share This


More From ScienceDaily



More Health & Medicine News

Sunday, March 29, 2015

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

S. Leone in New Anti-Ebola Lockdown

S. Leone in New Anti-Ebola Lockdown

AFP (Mar. 28, 2015) — Sierra Leone imposed a three-day nationwide lockdown Friday for the second time in six months in a bid to prevent a resurgence of the deadly Ebola virus. Duration: 01:17 Video provided by AFP
Powered by NewsLook.com
These Popular Antibiotics Can Cause Permanent Nerve Damage

These Popular Antibiotics Can Cause Permanent Nerve Damage

Newsy (Mar. 27, 2015) — A popular class of antibiotic can leave patients in severe pain and even result in permanent nerve damage. Video provided by Newsy
Powered by NewsLook.com
WH Plan to Fight Antibiotic-Resistant Germs

WH Plan to Fight Antibiotic-Resistant Germs

AP (Mar. 27, 2015) — The White House on Friday announced a five-year plan to fight the threat posed by antibiotic-resistant bacteria amid fears that once-treatable germs could become deadly. (March 27) Video provided by AP
Powered by NewsLook.com
House Ready to Pass Medicare Doc Bill

House Ready to Pass Medicare Doc Bill

AP (Mar. 26, 2015) — In rare bipartisan harmony, congressional leaders pushed a $214 billion bill permanently blocking physician Medicare cuts toward House passage Thursday, moving lawmakers closer to resolving a problem that has plagued them for years. (March 26) Video provided by AP
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
 
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:  

Breaking News:

Strange & Offbeat Stories

 

Health & Medicine

Mind & Brain

Living & Well

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:  

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile iPhone Android Web
Follow Facebook Twitter Google+
Subscribe RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins