Featured Research

from universities, journals, and other organizations

Conflict-of-interest restrictions needed to ensure strong FDA review

Date:
June 6, 2013
Source:
George Washington University School of Public Health and Health Services
Summary:
A 2012 law that loosened conflict-of-interest restrictions for FDA advisory panels could weaken the agency's review system and could allow more drugs with safety problems to gain market approval, says a new analysis.

A 2012 law that loosened conflict-of-interest restrictions for FDA advisory panels could weaken the agency's review system and could allow more drugs with safety problems to gain market approval, says a new analysis published June 7 in Science by researchers at the George Washington University School of Public Health and Health Services (SPHHS).

Related Articles


The 2012 legislation removed measures put in place by an earlier law passed in 2007, according to the report by Susan F. Wood, PhD, an associate professor of health policy at SPHHS and Jillian K. Mador, a medical student at the GW School of Medicine & Health Sciences (SMHS). The 2007 FDA Amendments Act put caps on the number of experts with conflict of interest who could serve on FDA advisory panels in order to ensure an impartial review of new drugs, the authors said.

They say there is good reason to worry about the revisions in the law that now allow FDA panels to have more members who report a conflict -- such as consulting fees from drug companies. The removal of the requirement for "caps" on advisory committee members with financial conflicts was seen as a top priority of the pharmaceutical industry during the 2012 passage of the FDA Safety and Innovation Act.

"Panels top-heavy with experts who have financial ties to industry might be more likely to dismiss or ignore scientific evidence of risks or other problems," said Wood, who is a former FDA official and the lead author on the paper. "This analysis also suggests that loosening the restrictions could lead to an appearance of conflict -- and to potentially biased recommendations for approval or disapproval of a FDA regulated product."

The authors point to historical examples of cases in which loaded panels voted for drugs that were later found to have serious safety problems.

The 2012 law was passed after the drug industry complained that the conflict of interest restrictions slowed down the FDA approval process and made it hard to fill panel positions with qualified experts. But Wood and Mador looked at the evidence and concluded that there are plenty of scientists with expertise to fill these positions -- without the ties to the industry.

The analysis goes on to say that the restrictions did not affect FDA's productivity in the past and there is little reason to think that reinstituting the caps would slow down the process of bringing safe new drugs to market today. The analysis also demonstrates that the caps have never been reached, so FDA had apparently been successful in identifying experts without financial conflicts.

The analysis concludes that the evidence does not support the decision to remove the caps on conflict of interest and points out that Congress will soon begin discussing reauthorization of the 2012 law which is revised every five years. The authors urge the scientific and medical community to weigh in early on those discussions in order to point out concerns -- and to ensure that the FDA Advisory Committee and review process remains strong and effective.


Story Source:

The above story is based on materials provided by George Washington University School of Public Health and Health Services. Note: Materials may be edited for content and length.


Journal Reference:

  1. S. F. Wood, J. K. Mador. Uncapping Conflict of Interest? Science, 2013; 340 (6137): 1172 DOI: 10.1126/science.1231955

Cite This Page:

George Washington University School of Public Health and Health Services. "Conflict-of-interest restrictions needed to ensure strong FDA review." ScienceDaily. ScienceDaily, 6 June 2013. <www.sciencedaily.com/releases/2013/06/130606154706.htm>.
George Washington University School of Public Health and Health Services. (2013, June 6). Conflict-of-interest restrictions needed to ensure strong FDA review. ScienceDaily. Retrieved March 31, 2015 from www.sciencedaily.com/releases/2013/06/130606154706.htm
George Washington University School of Public Health and Health Services. "Conflict-of-interest restrictions needed to ensure strong FDA review." ScienceDaily. www.sciencedaily.com/releases/2013/06/130606154706.htm (accessed March 31, 2015).

Share This


More From ScienceDaily



More Science & Society News

Tuesday, March 31, 2015

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

Models in Masks Highlight Indonesian Environmental Devastation

Models in Masks Highlight Indonesian Environmental Devastation

AFP (Mar. 31, 2015) — Wearing gas masks and designer dresses, models condemn the fashion industry&apos;s role in causing environmental devastation. Duration: 00:40 Video provided by AFP
Powered by NewsLook.com
The Future Of Japanese Whaling: Heritage Vs. Conservation

The Future Of Japanese Whaling: Heritage Vs. Conservation

Newsy (Mar. 30, 2015) — In 2014, the International Court of Justice ruled Japan could no longer engage in whaling in the Antarctic, but Japan has plans to return this year. Video provided by Newsy
Powered by NewsLook.com
Soda, Salt and Sugar: The Next Generation of Taxes

Soda, Salt and Sugar: The Next Generation of Taxes

Washington Post (Mar. 30, 2015) — Denisa Livingston, a health advocate for the Dinι Community Advocacy Alliance, and the Post&apos;s Abby Phillip discuss efforts around the country to make unhealthy food choices hurt your wallet as much as your waistline. Video provided by Washington Post
Powered by NewsLook.com
UnitedHealth Buys Catamaran

UnitedHealth Buys Catamaran

Reuters - Business Video Online (Mar. 30, 2015) — The $12.8 billion merger will combine the U.S.&apos; third and fourth largest pharmacy benefit managers. Analysts say smaller PBMs could also merge. Fred Katayama reports. Video provided by Reuters
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

 

Science & Society

Business & Industry

Education & Learning

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