Navigation Links
Broad Stakeholder Coalition Concludes that the 'Pathway for Biosimilars Act' Fails to Ensure Timely Access to Safe, Affordable Biogeneric Medicines for Patients
Date:3/14/2008

WASHINGTON, March 14 /PRNewswire-USNewswire/ -- The Coalition for a Competitive Pharmaceutical Market (CCPM) -- the organization representing a broad range of pharmaceutical stakeholders, including large national employers, insurers, pharmacies and generic drug manufacturers -- strongly urges Congress to develop legislation that will provide safe, effective and affordable biogenerics to consumers. This legislation must provide an appropriate balance between innovation and access to affordable biogenerics through competition.

The Pathway for Biosimilars Act will not bring timely patient access to safe and affordable biogeneric medicines as it fails to provide for a workable approval pathway or promote much needed competition in the biopharmaceutical marketplace. Under the Pathway for Biosimilars Act, it will be at least a decade before patients have access to more affordable biopharmaceuticals.

"It is widely acknowledged that the science exists to permit FDA to approve safe and effective comparable and interchangeable biogeneric products," said Katie Huffard, Executive Director of CCPM. "We urge Congress to create a workable pathway that relies on the FDA's scientific expertise to assure safety and effectiveness -- a pathway that ensures no undue delays to market entry and enhanced patient choice."

CCPM has worked diligently in a bipartisan fashion to help pass legislation that provides patients and their physicians access to safe, effective biogeneric medicines. CCPM supports passage of legislation this year that achieves these goals and will continue to work for balanced legislation this year and look for opportunities for compromise. To ensure that consumers, businesses and our health care system truly benefit from biogenerics legislation, Congress must pass a bill that:

-- Creates a workable FDA approval process for both comparable and interchangeable products

-- Provides for timely resolution of patent disputes

-- Encourages innovation by both brand and generic companies without requiring excessive, unprecedented, and unjustified market exclusivity, data exclusivity or patent extension provisions

CCPM urges members of the House of Representatives to return to the fundamental principles embodied in the bipartisan Access to Life Saving Medicines Act. This legislation, which is supported by consumer and patient advocates, employers, health plans, pharmacies and others, would create a meaningful and workable FDA approval pathway without excessive barriers to timely consumer access.

"American purchasers of pharmaceuticals are looking for action, but the bill must appropriately balance innovation and competition." said Huffard. "Congress has the ability to pass a landmark bill that will make a difference in the health of countless Americans. We well recognize that compromise will be required, but the Pathway for Biosimilars Act fails to make meaningful steps in this regard. We urge Members of Congress from both parties to ensure the pathway works for patients, employers, health plans as well as brand and generic industries."

CCPM supports public policies that facilitate timely access to affordable pharmaceuticals. Visit http://www.competitiverx.com for more information and a list of CCPM members.


'/>"/>
SOURCE Coalition for a Competitive Pharmaceutical Market
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. Broad-based group of physicians calls for improvement in stroke treatment
2. Euro RSCG Life Broadens X2 Expertise
3. Revolutionary HD Surgical Footage from North Shore-LIJ Surgeon to be Broadcast for the First Time on ABCs 20/20, National Geographic Channel
4. Drug Detection Kits Manufactured By IDenta Corp. Shown During French Television Broadcast (at TF1) - Product Aids French Police In Bust of 600 Kilograms Of Cocaine
5. SATELLITE BROADCAST: Consumer Group Says Hillary Clintons Mandatory Health Insurance Plan is an Act of War on the Middle Class that Cant Afford $12k Policy
6. Verizon Introduces Broadband Video Call Center Link for Deaf or Hard-of-Hearing Customers in Mid-Atlantic Region
7. Incidental findings found when radiologists take a broader look at renal MRA
8. Sanarus Announces Partnership With Leading US Breast Care Physicians for the Next Generation Visica 2(TM) Treatment System for Fibroadenomas
9. Staffing Agency Hires Local Television News Team, Launches Broadband Network for Nurses
10. Abbott Broadens Use of i-STAT Handheld Blood Analyzer with CLIA Waiver Granted by FDA for CHEM8+ Test Cartridge
11. Regence CEO to Chair National Effort Promoting Broader Health Care Stewardship
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/26/2016)... N.J. (PRWEB) , ... June 27, 2016 , ... Quality ... sources, yet in many ways they remain in the eye of the beholder, according ... (EBO), a publication of The American Journal of Managed Care. For the full issue, ...
(Date:6/26/2016)... ... ... Brent Kasmer, a legally blind and certified personal trainer is helping to develop a weight ... app plans to fix the two major problems leading the fitness industry today:, ... program , They don’t eliminate all the reasons people quit their exercise program ...
(Date:6/25/2016)... ... June 25, 2016 , ... The temporary closing of Bruton Memorial Library on June 21 ... brings up a new, often overlooked aspect of head lice: the parasite’s ability to live ... not a common occurrence, but a necessary one in the event that lice have simply ...
(Date:6/25/2016)... , ... June 25, 2016 , ... ... and non-athletes recover from injury. Recently, he has implemented orthobiologic procedures as a ... area —Johnson is one of the first doctors to perform the treatment. Orthobiologics ...
(Date:6/24/2016)... ... June 24, 2016 , ... Those who have experienced traumatic ... many turn to unhealthy avenues, such as drug or alcohol abuse, as a coping ... released tools for healthy coping following a traumatic event. , Trauma sufferers tend to ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... 2016 The Academy of Managed Care Pharmacy ... that would allow biopharmaceutical companies to more easily share ... formulary and coverage decisions, a move that addresses the ... The recommendations address restrictions in the sharing ... drug label, a prohibition that hinders decision makers from ...
(Date:6/24/2016)... 2016   Pulmatrix, Inc ., (NASDAQ: ... drugs, announced today that it was added to the ... its comprehensive set of U.S. and global equity indexes ... important milestone for Pulmatrix," said Chief Executive Officer ... our progress in developing drugs for crucial unmet medical ...
(Date:6/23/2016)... BEVERLY HILLS, Calif. , June 23, 2016 ... faced the many challenges of the current process. Many of ... option because of the technical difficulties and high laboratory costs ... would have to offer it at such a high cost ... to afford it. Dr. Parsa Zadeh , ...
Breaking Medicine Technology: