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are later reported from the marketplace, and a large number of patients are unnecessarily injured before the drugs are withdrawn or better managed.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:


(Date:1/19/2017)... ... January 19, 2017 , ... ... CTMS, which provides a modern CTMS workflow designed to seamlessly integrate and streamline ... been condensed to a single page, maximizing usability and improving efficiency significantly for ...
(Date:1/19/2017)... San Antonio, Texas (PRWEB) , ... January 19, 2017 , ... ... entering the GenCure Tissue Donation Awareness Scholarship competition., The winner will earn a $1,000 ... media accounts. The competition begins Feb. 1, and the deadline is May 31, with ...
(Date:1/19/2017)... PETALUMA, CA (PRWEB) , ... January 19, 2017 ... ... new Tranquility acoustic and privacy panel system. , The Tranquility privacy panel ... to a collaborative office environment. Tranquility panels help reduce noise and provide the ...
(Date:1/19/2017)... Pittsburgh, PA (PRWEB) , ... January 19, 2017 , ... ... the experience of patients who seek access to the Network’s programs and services in ... requesting primary or specialty care appointments will be offered one for that same afternoon. ...
(Date:1/19/2017)... , ... January 19, 2017 , ... ... protection and financial planning services to communities throughout eastern Georgia, is embarking on ... heart disease. , Heart disease kills more Americans every year than anything else, ...
Breaking Medicine News(10 mins):
(Date:1/19/2017)... , Jan. 19, 2017 The U.S. Food ... of Chronic Idiopathic Constipation (CIC) in adult patients. ... chronic gastrointestinal disorders," said Julie Beitz , M.D., director ... Center for Drug Evaluation and Research. "With the availability of ... appropriate treatment for their condition." ...
(Date:1/19/2017)... 19, 2017 Report Details ... Alzheimer,s Disease ... Companies – our new study reveals trends, R&D progress, ... events affecting the Alzheimer,s disease therapeutics and diagnostics market. ... key questions: - How is the Alzheimer,s disease therapeutics ...
(Date:1/19/2017)... CITY, N.J. , Jan. 19, 2017 ... over $100 for their medication when a pharmacy just ... same exact prescription.  To alleviate this problem Medicationdiscountcard.com ... and patients to see exactly how much their medication ... Comparison Shopping Made Easy ...
Breaking Medicine Technology:
Cached News: