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:6/24/2016)... India , June 24, 2016 ... Needles Market by Type (Standard Pen Needles, Safety Pen ... Therapy (Insulin, GLP-1, Growth Hormone), Mode of Purchase (Retail, ... by MarketsandMarkets, This report studies the market for the ... expected to reach USD 2.81 Billion by 2021 from ...
(Date:6/24/2016)... , June 24, 2016  Arkis BioSciences, a ... invasive and more durable cerebrospinal fluid treatments, today ... The Series-A funding is led by Innova Memphis, ... and other private investors.  Arkis, new financing will ... and the market release of its in-licensed Endexo® ...
(Date:6/23/2016)... 2016 Any dentist who has made an implant ... process. Many of them do not even offer this as ... high laboratory costs involved. And those who ARE able to ... a high cost that the majority of today,s patients would ... Parsa Zadeh , founder of Dental Evolutions Inc. and inventor ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... June 25, 2016 , ... Experts from the ... AcademyHealth’s Annual Research Meeting June 26-28, 2016, at the Hynes Convention Center in ... topics including advance care planning, healthcare costs and patient and family engagement. , ...
(Date:6/25/2016)... ... ... Bruton Memorial Library on June 21 due to a possible lice infestation, as reported by ... lice: the parasite’s ability to live away from a human host, and to infest common ... the event that lice have simply gotten out of control. , As lice are a ...
(Date:6/25/2016)... (PRWEB) , ... June 25, 2016 , ... First ... United States, named Dr. Sesan Ogunleye, as the Medical Director of its new Mesquite-Samuell ... facility Medical Director of our new Mesquite location,” said Dr. James M. Muzzarelli, Executive ...
(Date:6/25/2016)... ... June 25, 2016 , ... Dr. Calvin ... injury. Recently, he has implemented orthobiologic procedures as a method for treating his ... of the first doctors to perform the treatment. Orthobiologics are substances that orthopaedic ...
(Date:6/25/2016)... ... June 25, 2016 , ... Conventional wisdom preaches the benefits ... terms of the latter, setting the bar too high can result in disappointment, perhaps ... slow progress toward their goal. , Research from PsychTests.com reveals that ...
Breaking Medicine News(10 mins):