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 October 31, 2014 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 October 31, 2014).

Share This



More Health & Medicine News

Friday, October 31, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

Melafind: Spotting Melanoma Without a Biopsy

Melafind: Spotting Melanoma Without a Biopsy

Ivanhoe (Oct. 31, 2014) The MelaFind device is a pain-free way to check suspicious moles for melanoma, without the need for a biopsy. Video provided by Ivanhoe
Powered by NewsLook.com
Battling Multiple Myeloma

Battling Multiple Myeloma

Ivanhoe (Oct. 31, 2014) The answer isn’t always found in new drugs – repurposing an ‘old’ drug that could mean better multiple myeloma treatment, and hope. Video provided by Ivanhoe
Powered by NewsLook.com
Chronic Inflammation and Prostate Cancer

Chronic Inflammation and Prostate Cancer

Ivanhoe (Oct. 31, 2014) New information that is linking chronic inflammation in the prostate and prostate cancer, which may help doctors and patients prevent cancer in the future. Video provided by Ivanhoe
Powered by NewsLook.com
Sickle Cell: Stopping Kids’ Silent Strokes

Sickle Cell: Stopping Kids’ Silent Strokes

Ivanhoe (Oct. 31, 2014) Blood transfusions are proving crucial to young sickle cell patients by helping prevent strokes, even when there is no outward sign of brain injury. Video provided by Ivanhoe
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