Navigation Links
House Voting Today on FDA Reform Act
Date:5/30/2012

WASHINGTON, May 30, 2012 /PRNewswire-USNewswire/ -- The House is scheduled to vote on the Food and Drug Administration Reform Act today.  The House bill is weaker than similar legislation passed by the Senate last week.  Neither bill includes important provisions needed to protect patients from unsafe medical devices, according to Consumers Union, the policy and advocacy arm of Consumer Reports. 

"The FDA is hamstrung by a weak medical device law that leaves patients at risk of serious injury and even death," said Lisa Swirsky, senior policy analyst for Consumers Union.  "While both bills include some provisions that will improve the FDA's ability to track devices once they are on the market, only the Senate offers a provision that may improve safety before devices reach consumers. Both bills lack key consumer protections needed to help ensure devices are safe and effective before, not after, patients use them."

The House bill does not include a number of important provisions that were included in the Senate legislation last week:

  • A provision that would allow the FDA to more easily re-classify problematic devices so that subsequent, similar devices will receive more scrutiny before they get to patients.
  • A timeframe for implementing proposed regulations on unique device identifiers.  Once these rules are in place, the FDA will be better able to track problematic devices and make sure patients are warned about safety problems.
  • A provision that codifies the requirement that approval for high-risk devices is contingent on completing required post market studies. This should make it easier to impose civil monetary penalties on bad actors, leveling the playing field for companies that comply.
  • A timeline on 522 post-market studies for devices that had been cleared in the fast track 510k process, aiding the FDA in reacting more quickly when device safety issues have been identified.

Neither the House nor the Senate bill include a number of critical patient safety protections, including:    

  • Providing the FDA with the authority to reject new devices based on their similarities to devices recalled by manufacturers for safety reasons
  • A national registry for tracking medical implant problems and notifying patients when problems arise.  Similar registries are used in Australia and the UK that have allowed them to track and evaluate how patients with implants and other high-risk devices are faring. 
  • Stronger authority for the FDA to require post market studies; and
  • Keeping existing conflict of interest limitations for people serving on FDA advisory panels that approve drugs and devices. 

For more details on these important patient safety provisions, see Consumers Union's news release on last week's Senate vote on the FDA Safety and Innovation Act.


'/>"/>
SOURCE Consumers Union
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. BioSurplus Expands, Debuts New 8000 Square Foot Warehouse and Service Facility
2. Dont Give Your Pet a Deadly Dose; Medicines Top the List of Household Poisons for Pets
3. Pennsylvania Hospital Data Shows Increased Likelihood of Medication Errors When In-House Pharmacy is Closed
4. FRCs Jeanne Monahan Testifies Before House Judiciary Committee, Urges Repeal of Discriminatory Mandate
5. The Centers for Disease Control & Prevention Signs Vaccine Warehouse and Distribution Contract with Sentry BioPharma Services
6. HealthWarehouse.com Partners With MedLion to Bring Affordable Healthcare to Northern California
7. Consumers Union to Testify for Stronger Medical Device Safety Oversight at House Hearing Today
8. Medical Alarm Concepts™ Chosen as a Strategic Alliance Partner with Costco Warehouse Clubs
9. Bipartisan Group of 22 House Members ask CMS to Stop Prepayment Review Project that would Jeopardize Care for Medicare Beneficiaries
10. HealthWarehouse.com Offers Lowest Price Generic Lipitor on the Market
11. HealthWarehouse.com Reports 129% Quarter-Over-Quarter Revenue Growth in the Third Quarter 2011
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/12/2017)... West Pharmaceutical Services, Inc. (NYSE: ... drug administration, today announced that it will release third-quarter ... October 26, 2017, and will follow with a conference ... 9:00 a.m. Eastern Time. To participate on the call, ... ID is 94093362. ...
(Date:10/11/2017)... 2017  True Health, a leader in integrated ... during National Breast Cancer Awareness month to educate ... Research recently published ... more than 10 million American women are at ... or BRCA2 and have not had testing. These mutations ...
(Date:10/10/2017)... Oct. 10, 2017   West Pharmaceutical Services, Inc. ... for injectable drug administration, today shared the results of ... for improving the intradermal administration of polio vaccines. The ... Summit in May 2017 by Dr. Ondrej Mach ... World Health Organization (WHO), and recently published in the ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... ... Apple Rehab Shelton Lakes , which specializes in the delivery of sub-acute ... of a disaster drill on October 3rd. , Apple Rehab participated with the Shelton ... well as the Connecticut Long Term Care Mutual Aid Plan (LTC-MAP). The LTC-MAP ...
(Date:10/13/2017)... ... October 13, 2017 , ... Global Healthcare Management’s 4th Annual Kids Fun Run ... This free event, sponsored by Global Healthcare Management’s CEO, Jon Letko, is aimed ... geared towards children of all ages; it is a non-competitive, non-timed event, which is ...
(Date:10/13/2017)... , ... October 13, 2017 , ... “The Journey: From ... every danger possible to save lost souls in the Philippines. “The Journey: From the ... is a dedicated teacher of the Bible. She has taught all ages and currently ...
(Date:10/12/2017)... LA (PRWEB) , ... October 12, 2017 , ... Planet ... in the U.S., announced today its plans to open a flagship location in Covington, ... occupy the former Rooms To Go store next to Office Depot in the Holiday ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... leader in post-acute health care, have expanded their existing home health joint venture ... , AccentCare has been operating a joint venture home health company with Asante, ...
Breaking Medicine News(10 mins):