Navigation Links
FDA to Broaden Disclosure on Advisers' Conflicts of Interest
Date:4/21/2010

Agency has faced criticism in the past over the issue

WEDNESDAY, April 21 (HealthDay News) -- The U.S. Food and Drug Administration on Wednesday proposed new guidelines to help give the public more information on the experts the agency places on its all-important advisory committees, which help approve drugs and devices.

The FDA has in the past been criticized for allowing individuals with conflict of interests to serve on these panels. In some cases, prospective committee members with financial or other ties to a product under discussion can still receive special conflict-of-interest waivers that allow their participation on an advisory panel.

But on Wednesday the agency proposed new guidelines that, in its words, would "expand transparency and [public] disclosure" whenever one of these waivers are handed out.

FDA advisory committees provide the agency with advice on a wide range of topics, including drugs, medical devices and tobacco. They also provide key advice on regulatory decisions, such as product approvals and general policy matters. While the FDA is not bound to follow its committees' recommendations, it usually does.

"The primary goal of the advisory committee process is to bring high-quality input to FDA to inform our decision making," Jill Hartzler Warner, the FDA's acting associate commissioner for special medical programs, explained during a press conference Wednesday.

The new guidelines would expand the information disclosed to the public whenever the FDA grants a conflict-of-interest waiver, Warner said.

The FDA has 49 advisory committees with room for more than 600 members. Currently, there are over 200 vacancies on these committees, according to the agency.

Under the proposed guidelines, the FDA would disclose conflict-of-interest waivers before committee meetings, naming the company or institution and any financial interest advisers might have as well as the specific conflict of interest.

"In my view, it is clearly better for the agency in fulfilling its public health mission when advisers have no conflicts of interest," FDA Commissioner Dr. Margaret A. Hamburg wrote in a letter to senior agency officials. "FDA staff should search far and wide for experts who have the requisite knowledge without conflicts of interest. At the same time, however, I recognize the fact that many of the top authorities in specific areas may have conflicts of interest."

In the letter, Hamburg outlined three steps to consider before a conflict-of-interest waiver is given. These include:

  • Defining the nature of the conflict of interest before recommending giving a waiver. "Not all conflicts are created equal. For example, an academic researcher whose institution receives grants from an affected company but who does not personally participate in the studies has a more tangential relationship to the conflict than the researcher who conducts studies for the company directly," she wrote.
  • Weighing the kind of advice the committee is being asked for. "A waiver may be more appropriate for a meeting about a policy issue affecting a class of entities or products than for a meeting focusing on approval of a specific product," Hamburg explained.
  • Determining why expert advisers without conflicts could not be found and why the individual under scrutiny is needed.

"Conflict-of-interest waivers for scientific advisers have been controversial, however," Hamburg wrote. "If FDA is perceived to rely heavily on conflicted experts, then confidence in the agency's decision-making can be undermined."

More information

For more on the proposed guidelines, visit the U.S. Food and Drug Administration.



SOURCES: April 21, 2010, teleconference with Jill Hartzler Warner, J.D., acting associate commissioner for special medical programs, U.S. Food and Drug Administration; April 21, 2010, letter, Margaret A. Hamburg, M.D., commissioner, U.S. Food and Drug Administration


'/>"/>
Copyright©2010 ScoutNews,LLC.
All rights reserved

Related medicine news :

1. Healthy Aging Global Leader Broadens Patient Exercise/Nutrition Success With Online Living Site
2. SOKO Fitness & Spa Group Broadens Geographic Expansion Strategy
3. Pivot Networks and Brookside Technology Partners, Inc. Team to Broaden Managed IT Services Offering for Texas SMBs
4. BD Applauds PEPFARs Broadened Emphasis on Strengthening Health Systems
5. Comcast and Stand Up To Cancer Launch First-Ever Video-on-Demand Effort to Broaden Awareness and Raise Funds for Cancer Research
6. Vend Marketing Institute Calls on Congress to Modify Calorie Disclosure Requirement: Supports Existing Disclosure Which Is More Complete and Effective
7. FDA Advisers Urge Stricter Regulation of Tanning Beds
8. Primary care physicians nationwide face clinical ethical conflicts with religious hospitals
9. Couples who say we do better at resolving conflicts
10. NursePractitionerBusinessOwner.com Announces No-Charge Teleseminar for Nurse Practitioners Interested in Starting Their Own Practice
11. Study shows strong interest in palliative care programs, services and integration vary across nation
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/12/2017)... ... October 12, 2017 , ... ... the demand of today’s consumer and regulatory authorities worldwide. From Children’s to Adults ... tested to meet the highest standard. , These products are also: Gluten ...
(Date:10/12/2017)... ... , ... The American College of Medical Informatics (ACMI) will present the 2017 ... Session of AMIA’s Annual Symposium in Washington, D.C. AMIA’s Annual Symposium is ... pioneer in the field of medical informatics, this prestigious award is presented to an ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... system that we intend to develop to enable prevention of a major side ... severe hearing loss, especially in pediatric patients. For cisplatin, hearing loss is FDA ...
(Date:10/12/2017)... ... October 12, 2017 , ... HMP , a leader ... a 2017 Folio Magazine Eddie Digital Award for ‘Best B-to-B Healthcare Website.’ Winners were ... 11, 2017. , The annual award competition recognizes editorial and design excellence across a ...
(Date:10/12/2017)... , ... October 12, 2017 , ... On Saturday, October ... treadmill relay – Miles by Moonlight to raise money for the American Heart Association ... more. , Teams will work together to keep their treadmills moving for 5 ...
Breaking Medicine News(10 mins):
(Date:9/25/2017)... 2017   Montrium , an industry leader ... the IQPC Trial Master Files & Inspection Readiness ... EastHORN Clinical Services has selected eTMF Connect ... management. EastHORN, a leading European contract research organization ... transparency to enable greater collaboration with sponsors, improve ...
(Date:9/22/2017)... Sept. 22, 2017  As the latest Obamacare repeal ... Bill Cassidy (R-LA) and Lindsey Graham ... the medical device industry is in an odd place. ... the 2.3% excise tax on medical device sales passed ... want covered patients, increased visits and hospital customers with ...
(Date:9/19/2017)... , Sept. 19, 2017   ZirMed Inc ., a ... today announced that it has been ranked #1 by its ... Book™ Rankings 2017 User Survey. ZirMed was recognized as ... large hospitals and medical centers over 200 beds and holds ... healthcare technology user survey history. ...
Breaking Medicine Technology: