HOME >> MEDICINE >> NEWS
Proposal calls for sweeping changes at US Food and Drug Administration

WINSTON-SALEM, N.C. -- Five current or former members of the Drug Safety and Risk Management Advisory Committee to the U.S. Food and Drug Administration (FDA) called today for Congress to make sweeping changes to deal with a large number of longstanding problems at the agency.

"The current FDA system of regulating drug safety has serious limitations and is in need of changes," they say in Archives of Internal Medicine, released today. Since Congress is ultimately responsible, "it is up to Congress to take the steps necessary to reinvigorate the FDA's ability to assure the public that approved medical products are safe."

Curt D. Furberg, M.D., Ph.D., professor of public health sciences at Wake Forest University School of Medicine and the lead author, said the five decided to write the analysis after becoming discouraged by the FDA's inability to fix its own problems.

"Congress has not provided adequate funding and authority to the FDA," he said.

The group cites eight major problems impacting FDA performance, including:

  • The system of initial approval of drugs often fails to detect serious adverse drug reactions.
  • The same FDA center that approves drugs also has the responsibility of taking safety actions, creating a conflict-of-interest situation.
  • The FDA is overly dependant on user fees from drug companies.
  • The FDA is short on expertise in drug safety and public health.

"The key features of today's media stories about questionable drug safety are the same as with previous drug tragedies," Furberg said. "New drugs are introduced on the market with inadequate safety documentation; serious adverse drug reactions are later reported from the marketplace, and a large number of patients are unnecessarily injured before the drugs are withdrawn or better managed. The only difference is the name of the culprit drug."

Furberg and his colleagues recommend that Congress make five changes:

    '"/>


Contact: Robert Conn
rconn@wfubmc.edu
336-716-4587
Wake Forest University Baptist Medical Center
9-Oct-2006


Page: 1 2

Related medicine news :

1. Report calls for new directions, innovative approaches in testing chemicals for toxicity to humans
2. National Academy of Sciences Institute of Medicine report calls for more dairy foods at school
3. Report calls for using heated chemotherapy after colon cancer surgery to optimize patient survival
4. Civil society movement calls for transparency in the WHO director-general elections
5. Study calls for 39 percent more family physicians
6. The Lancet calls for transparency in the selection of a new executive director for the global fund
7. The Lancet calls on research community to address neglected disease that causes heart failure
8. International AIDS Vaccine Initiative calls for new measures to search for an AIDS vaccine
9. Who calls for stronger collaboration between HIV/AIDS and TB programs in the developing world
10. New data finds recalls of automated external defibrillators to be common
11. World Hypertension League calls for urgent action to get more hypertensive patients to goal

Post Your Comments:
*Name:
*Comment:
*Email:
TAG: Proposal calls for sweeping changes Food and Drug Administration

(Date:8/22/2014)... (PRWEB) August 22, 2014 AWeber, ... services that currently helps more than 120,000 small ... caught the attention of Shane Michaels, prompting an investigative ... crucial element for any online marketing campaign, despite what ... in the marketing world,” reports Michaels. “AWeber is a ...
(Date:8/22/2014)... Buying a policy for different life insurance products can ... coverage types by insurers in the U.S. The Quotes Pros ... the public using its sortable tool at http://quotespros.com/life-insurance.html . ... is expected to promote the discounts and special offerings for ... The system is designed to help an adult locate a ...
(Date:8/22/2014)... Indiana (PRWEB) August 22, 2014 The ... Toyota Indiana is on the grow again. ... 300 jobs by summer 2016 to boost production of ... will bring Toyota Indiana’s overall investment to $4 billion. ... North America while providing additional flexibility to adjust its ...
(Date:8/22/2014)... York (PRWEB) August 22, 2014 ... morcellators ( http://www.injurybeacon.com/power-morcellator/ ) in uterine surgeries continues ... Massachusetts insurance companies have decided to limit coverage ... the Worcester Telegram, Blue Cross-Blue Shield of Massachusetts ... surgeries that involve morcellation as of September 1, ...
(Date:8/22/2014)... 11 (BIM) deletion in advanced non-small cell lung ... survival (PFS) in epidermal growth factor receptor (EGFR) ... patients. Also, BIM deletion independently predicts overall survival ... protein can activate the programmed cell death also ... deletion has been detected in 12.8% of the ...
Breaking Medicine News(10 mins):Health News:AWeber: Review Exposes Affordable Provider of Opt-In Email Marketing Services 2Health News:Principal Life Insurance Policies Now Quoted for Adults at Insurance Website Online 2Health News:Toyota Indiana Adding 300 Jobs to Build More Highlanders 2Health News:As Power Morcellator Controversy Grows, Bernstein Liebhard LLP Comments on Massachusetts Insurers’ Plans to Limit Coverage of Uterine Morcellation 2Health News:As Power Morcellator Controversy Grows, Bernstein Liebhard LLP Comments on Massachusetts Insurers’ Plans to Limit Coverage of Uterine Morcellation 3Health News:As Power Morcellator Controversy Grows, Bernstein Liebhard LLP Comments on Massachusetts Insurers’ Plans to Limit Coverage of Uterine Morcellation 4Health News:Deletion predicts survival in advanced non-small cell lung cancer 2
(Date:8/21/2014)... 21, 2014  eRelevance Corporation ( www.erelevancecorp.com ), ... that it has completed integration with Nextech, a ... Surgery and Dermatology practices. "Integration allows ... healthcare practices using Nextech," stated Bob Fabbio ... information from the EMR we are able to ...
(Date:8/21/2014)... Aug. 21, 2014  Decision Resources Group finds ... Brazil and ... and commonly prescribe long-acting beta-agonist (LABA)- and long-acting ... so within current severe cost/coverage constraints. Therefore, new ... expected to launch in these countries—which will considerably ...
(Date:8/21/2014)... announces the list of stocks featured in the Analyst Blog. ... news and events impacting stocks and the financial markets. Stocks ... - Free Report ), IBM (NYSE: IBM - Free ... Report ), GlaxoSmithKline plc (NYSE: GSK - Free Report ... Report ). Today, Zacks is promoting its ,Buy, ...
Breaking Medicine Technology:eRelevance Corporation Integrates with Nextech Electronic Medical Records 2Novel Fixed-Dose Combinations for COPD in Brazil and Mexico Will Compete With Well-Established Therapies in an Environment Dominated by Aggressive Cost-Control Mechanisms 2Novel Fixed-Dose Combinations for COPD in Brazil and Mexico Will Compete With Well-Established Therapies in an Environment Dominated by Aggressive Cost-Control Mechanisms 3The Zacks Analyst Blog Highlights: Hewlett-Packard, IBM, Safe Bulkers, GlaxoSmithKline and Frank's International 2The Zacks Analyst Blog Highlights: Hewlett-Packard, IBM, Safe Bulkers, GlaxoSmithKline and Frank's International 3The Zacks Analyst Blog Highlights: Hewlett-Packard, IBM, Safe Bulkers, GlaxoSmithKline and Frank's International 4The Zacks Analyst Blog Highlights: Hewlett-Packard, IBM, Safe Bulkers, GlaxoSmithKline and Frank's International 5The Zacks Analyst Blog Highlights: Hewlett-Packard, IBM, Safe Bulkers, GlaxoSmithKline and Frank's International 6The Zacks Analyst Blog Highlights: Hewlett-Packard, IBM, Safe Bulkers, GlaxoSmithKline and Frank's International 7The Zacks Analyst Blog Highlights: Hewlett-Packard, IBM, Safe Bulkers, GlaxoSmithKline and Frank's International 8The Zacks Analyst Blog Highlights: Hewlett-Packard, IBM, Safe Bulkers, GlaxoSmithKline and Frank's International 9The Zacks Analyst Blog Highlights: Hewlett-Packard, IBM, Safe Bulkers, GlaxoSmithKline and Frank's International 10The Zacks Analyst Blog Highlights: Hewlett-Packard, IBM, Safe Bulkers, GlaxoSmithKline and Frank's International 11
Cached News: