Navigation Links
FDA Advisors Declare 'FDA Science and Mission at Risk'
Date:12/3/2007

Broad-ranging Report Concludes that Increased Resources Are An Essential

First Step

WASHINGTON, Dec. 3 /PRNewswire-USNewswire/ -- The nation's food supply is at risk, as are the regulatory systems that oversee the nation's drug and device supplies, according to a subcommittee of the FDA's Science Board in a report to be presented today. The subcommittee attributes the deficiencies to soaring demands on the FDA; and resources that have not increased in proportion to those demands. They conclude that "this imbalance is imposing a significant risk to the integrity of the food, drug, cosmetic and device regulatory system, and hence the safety of the public."

The result of a year-long review by a distinguished panel of experts, the Subcommittee's 300-page report concludes that the state of FDA's scientific and regulatory programs could not be separated from the lack of resources. It urged funds to support the agency's scientific base, hire a broadly-capable scientific workforce, and build a sophisticated, modern information technology infrastructure.

The FDA Science Board meets from 8 a.m. to 5:30 p.m. on December 3 at the Gaithersburg, MD Hilton. The Subcommittee is scheduled to present at 12:30 p.m., with discussion continuing until 4 p.m. Its report has been posted on the FDA website in advance of the meeting and is available at: http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4329b_02_00_index.html .

Comments on the report:

"Over the last decade, complex scientific advances, globalization and challenging new safety issues have combined to multiply the responsibilities of the FDA. As this new report makes clear: our expectations cannot exceed the resources we give FDA to accomplish its mission. In this regard, more is definitely better."

--Mark McClellan, MD, former FDA commissioner and chairman of the new Reagan-Udall Institute.

"FDA can't improve its science, prepare for the future, or protect American consumers without significant additional resources. Congress is negotiating FDA's FY 2008 (current year) budget right now and can start to fix this critical problem."

--Don Kennedy, PhD, former FDA commissioner and editor-in-chief of Science.

"That FDA needs more resources should be obvious. What makes this report so extraordinary is the qualifications of the individuals who wrote it, the year-long process to put it together, and the depth of analysis that supports its conclusion: FDA's mission is at risk for lack of support for its scientific capabilities."

--Jane Henney, MD, former Commissioner of FDA and Senior Vice President and Provost for Health Affairs, University of Cincinnati.

About the FDA Alliance and the Coalition for a Stronger FDA

In response to the unmet resource needs of the FDA and the threat this poses to America's health, safety and commerce, two organizations were formed in 2006 to educate and advocate about the importance of FDA and the need for better funding. More about each group can be found on their websites: http://www.StrengthenFDA.org (FDA Alliance) and http://www.FDACoalition.org (Coalition for a Stronger FDA).


'/>"/>
SOURCE FDA Alliance
Copyright©2007 PR Newswire.
All rights reserved

Related medicine news :

1. Lincoln Financial Advisors to Provide Exclusive Services to American Osteopathic Association Members
2. Landauer, Inc. Declares Regular Cash Dividend
3. Weight Watchers Declares Quarterly Dividend
4. Ventas Declares Regular Quarterly Dividend of $0.475 Per Share
5. P.A.C.K. Week Declared in Support of Fruits & Veggies-More Matters Month
6. Abbott Declares 335th Consecutive Quarterly Dividend
7. MedCom USAs Subsidiary Card Activation Technologies, Inc.s SB2 Registration Declared Effective by SEC
8. HealthSouth Declares Dividend on 6.5% Series A Convertible Perpetual Preferred Stock
9. Colgate Declares Regular Quarterly Dividends
10. Governor Rendell Declares Senior Smiles Day in Pennsylvania; Goal is to Improve Oral Hygiene for Senior Citizens
11. Mayors Office Declares October 13 as First Metastatic Breast Cancer Awareness Day for New York City
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/27/2016)... Lafayette, California (PRWEB) , ... ... ... a pioneer in the patient payment industry today announced its strategic partnership ... and health system workflows. , The two companies’ proven, proprietary technology combine ...
(Date:6/26/2016)... (PRWEB) , ... June 26, 2016 , ... Pixel Film ... Pro X. , "Film editors can give their videos a whole new perspective by ... Austin - CEO of Pixel Film Studios. , ProSlice Levels contains over 30 ...
(Date:6/25/2016)... ... 2016 , ... Austin residents seeking Mohs surgery services, can now turn to ... Dr. Russell Peckham for medical and surgical dermatology. , Dr. Dorsey brings specialization to ... fellowship in Mohs Micrographic Surgery completed by Dr. Dorsey was under the direction of ...
(Date:6/25/2016)... Oklahoma City, Oklahoma (PRWEB) , ... June 25, ... ... to helping both athletes and non-athletes recover from injury. Recently, he has implemented ... for the Oklahoma City area —Johnson is one of the first doctors to ...
(Date:6/24/2016)... Marne, Michigan (PRWEB) , ... June 24, 2016 , ... ... awareness about the dangers associated with chronic pain and the benefits of holistic treatments, ... for individuals who are suffering with Sickle Cell Disease. , Sickle Cell Disease (SCD) ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... -- MedSource announced today that it has selected Datatrial,s ... choice.  This latest decision demonstrates MedSource,s commitment to ... by offering a state-of-the-art electronic data capture (EDC) ... the EDC platform of choice in exchange for ... long been a preferred EDC platform by our ...
(Date:6/23/2016)... -- Any dentist who has made an implant supported denture ... of them do not even offer this as a viable ... costs involved. And those who ARE able to offer that ... cost that the majority of today,s patients would not be ... , founder of Dental Evolutions Inc. and inventor of Implanova ...
(Date:6/23/2016)... June 23, 2016  In a startling report released today, ... residents by lacking a comprehensive, proven plan to eliminate prescription opioid ... ranking of how states are tackling the worst drug crisis in ... states – Kentucky , New Mexico ... . Of the 28 failing states, three – ...
Breaking Medicine Technology: