Navigation Links
Pro-Consumer Drug Safety Reforms Agreed to in Final FDA Bill; Should End Drug Industry Gaming of Safety System
Date:9/19/2007

House overwhelming approves bill, CU says major victory for patients

WASHINGTON, Sept. 19 /PRNewswire-USNewswire/ -- Nearly three years to the day Vioxx was removed from the market, Congress has completed a major drug safety reform bill that will give FDA the power to hold pharmaceutical companies accountable for safety problems, and help ensure the industry can't keep drug risks hidden from the public, Consumers Union said.

"Congress is about to give the President legislation that should end the secrecy and foot-dragging when it comes to letting consumers know about unsafe medicines," said Jim Guest, president of Consumers Union, publisher of Consumer Reports. "These reforms have been anxiously awaited by the millions of consumers who take a prescription drug every day and wonder if they know the truth about its side effects."

"Unfortunately, too many Americans suffered or lost their lives because they weren't given the straight story about safety risks by either the drug manufacturer or the FDA," Guest added. "It's now up to the FDA to enforce this law and make sure we get the straight story on the benefits and risks of drugs on the market."

A compromise was reached today by the Senate and House to reconcile differences between the two drug safety bills (S 1082 and HR 2900) passed earlier this year. The reforms are part of an underlying bill reauthorizing user fees on the pharmaceutical industry to fund the FDA drug approval process. The House approved the bill 405-7 today, with a Senate vote expected later this week. A final bill would then go to the President.

Two vital pro-consumer measures survived the closed-door negotiations - making important clinical drug trial results and adverse events public, and protecting a consumer's right to hold companies accountable in court if they're hurt by an unsafe drug.

The clinical trial language will require companies make public a technical summary of their trial result
'/>"/>

SOURCE Consumers Union
Copyright©2007 PR Newswire.
All rights reserved

0

GOOD

Page: 1 2 3 4

Related medicine news :

1. Alerts for safety of heart device
2. Surgery a safety in senility
3. Surgery a safety in senility
4. Surgery a safety in senility
5. New standards for Human Research Safety
6. Safety of soy under suspicion
7. The Safety Of Prenatal Ultrasounds Questioned
8. Report on the Safety and Effectiveness of Melatonin supplements
9. Monitoring Drug Safety
10. Testosterone patch for women Rejected For safety Reasons
11. Law ensuring safety and quality of Herbal drugs
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/21/2013)... (PRWEB) May 21, 2013 Artisan ... EB-5 Investment Summit: Dealmakers Conference in Long Beach, ... will focus on exploring alternative finance through EB-5 ... latest market, legal and economic information, and updates ... legal professionals within the EB-5 industry. , ...
(Date:5/21/2013)... York, New York (PRWEB) May 21, 2013 ... Wright Conserve hip replacement lawsuits in ... an Order in response to a request from Plaintiffs’ ... of the Defendant. The May 17th Order grants ... interviews may be conducted. (In re: Wright Medical Technology, ...
(Date:5/21/2013)... MedMar Healing Center announces their ... Harvest Food Bank. Twenty-eight businesses, including MedMar Healing Center, doctors, ... drive. The goal is to raise food to help area ... their families in recent years. , “We like being ... in need,” explains Douglas Chloupek of MedMar Healing Center. “Taking ...
(Date:5/21/2013)... CINCINNATIUsing the Department of Defense Serum Repository (DoDSR), University ... biomarkers for inflammatory bowel disease (IBD), which could help ... not yet shown symptoms. , This finding, the first ... MD, is being presented via podium presentation by staff ... Disease Week 2013, being held May 18-21 in Orlando, ...
(Date:5/21/2013)... May 21, 2013 Today, Zane Benefits, ... and FSA accounts. Zane Benefits, which provides comprehensive ... is the leader in defined contribution and ... . , According to Zane Benefits’ website, the Affordable ... signed into law in 2010 and impacts many areas ...
Breaking Medicine News(10 mins):Health News:Artisan Business Group to Host EB-5 Investment Conference in Long Beach, California 2Health News:Wright Hip Lawsuit News: Bernstein Liebhard LLP Notes Issuance of New Order in Federal Wright Conserve Hip Replacement Litigation 2Health News:Wright Hip Lawsuit News: Bernstein Liebhard LLP Notes Issuance of New Order in Federal Wright Conserve Hip Replacement Litigation 3Health News:San Jose Cannabis Club Helps Feed Hungry Children with Second Harvest Food Bank 2Health News:Biomarkers discovered for inflammatory bowel disease 2Health News:Zane Benefits Publishes New Information on HRA, HSA and FSA Accounts 2Health News:Zane Benefits Publishes New Information on HRA, HSA and FSA Accounts 3
... that sensible drinking, which can be likened to about two ... two drinks for women, may actually be a way to ... the risk of death, Italian researchers have said. ... their consumption, but people who already regularly consume low to ...
... sharp reductions in human immunodeficiency virus (HIV) levels, and ... with HIV infection. ,If the good results ... be a welcome addition to the existing treatment options ... study, led by Dr Martin Markowitz of The Rockefeller ...
... A multicenter study on treating common ear infections in ... of evidence that favors antibiotic ear drops over antibiotics ... a UT Southwestern Medical Center researcher reports. ... ear drops performed better and faster in treating middle ...
... explosion some 19 years ago had double hand transplant done on ... Spain, and worldwide first on a woman. ,A surgery ... ,The leading surgeon Pedro Cavadas said the patient was ... should get back full use of her hands within five to ...
... has always been regarded as one of the toughest and ... and also adds that the workload// and strain makes them ... and January 2006 on nearly 19,000 nurses, which included registered ... ,The overall observation was that nurses face a variety of ...
... his family spent a week of mental trauma after a private ... cleared of the disease after tests at a government hospital. ... positive for HIV by doctors at a private nursing home on ... sorrow with the fear of death hanging over him. ...
Cached Medicine News:Health News:New Drug Offers Promise as Single Treatment for HIV 2Health News:Antibiotic Ear Drops Favored Over Oral Antibiotics for Ear Infections 2Health News:Panic Gripped Young Man After Wrong Diagnosis With HIV 2
(Date:5/21/2013)... , 21 de mayo de 2013 La ... compañías filiales incluyen OMNIlife science®, Inc., Enztec, Ltd. y ... para su junta. Guy Mayer, un ejecutivo ortopédico experimentado, ... David Johnson , un experto refutado ... Antes de unirse a OSI como presidente ...
(Date:5/21/2013)... PHILADELPHIA , May 21, 2013 ... and impressive new product developments at the Special Libraries Association ... years of unerring focus on product literature databases and workflow ... mark the occasion," said founding director Nigel Johnson ... developments of benefit to our clients and what better forum ...
(Date:5/21/2013)... 21, 2013  Decision Resources, one of ... for pharmaceutical and healthcare issues, finds that ... key efficacy endpoints, including overall survival and ... influence over surveyed U.S. and European oncologists, ... HER2-negative breast cancer. The two novel emerging ...
Breaking Medicine Technology:Orthopaedic Synergy, Inc. anuncia nuevas incorporaciones a la junta directiva 2Orthopaedic Synergy, Inc. anuncia nuevas incorporaciones a la junta directiva 3Pi2 Solutions' 10th Anniversary Heralds New Corporate Image as Platinum Sponsor of SLA PHT Meeting in Philadelphia 2Pi2 Solutions' 10th Anniversary Heralds New Corporate Image as Platinum Sponsor of SLA PHT Meeting in Philadelphia 3Thought-Leader Opinion and Clinical Data Indicate that Emerging Agents from Two Drug Classes Have Efficacy Advantages Over Currently Used Therapies for HR-Positive, HER2-Negative Breast Cancer 2
...  - Agreement allows development for potential ... SHP, NASDAQ: SHPGY ), the global specialty ... rights to develop and market Resolor ® (prucalopride) ... Janssen Pharmaceutica N.V.  Terms of the agreement have not ...
... 2012  Transvaginal mesh will undergo new safety studies, as ... Elk & Elk are currently investigating transvaginal mesh claims. ... more than 30 transvaginal surgical mesh manufacturers, including Johnson ... to perform post-market safety studies after a fivefold increase ...
Cached Medicine Technology:Shire Acquires US Rights to Resolor(R) (prucalopride) 2Shire Acquires US Rights to Resolor(R) (prucalopride) 3Shire Acquires US Rights to Resolor(R) (prucalopride) 4Ohio Injury Lawyers Support FDA's Decision for Further Testing of Transvaginal Mesh 2
The TBR-360-1-GD is a large capacity upright style operating temperature +4C. It is specially designed refrigerators for the storage of blood in standard 500ml bags, complying with Australian Standar...
... is specially designed for ... in standard 500ml bags, ... AS3864 1997. Quiet hermetic ... CFC Free refrigerant with ...
... a direct competitive EIA for the ... serum or plasma. A specific agent ... it available for antibody binding. Testosterone ... linked to fluorescein isothiocyanate (FITC) and ...
... Vitamin B6 makes it possible to determine ... precise method. The kits includes all reagents ... separation of the samples with,exception of the ... the simultaneous handling of many analytes in ...
Medicine Products: