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[IN] MTC PHA HEA
[SU] AVO LEG
TO MEDICAL, AND NATIONAL EDITORS:
Twenty-one Healthcare Organizations Join GPhA Calling on FDA to
Reconsider Proposed Generic Labeling Rule
WASHINGTON, March 6, 2014 /PRNewswire-USNewswire/ -- In anticipation
of the March 13th deadline for comments on the FDA proposed rule on
prescription generic drug labeling, today 21 health industry groups
submitted a new letter to the FDA, raising concerns about the proposed
"Groups from every part of the healthcare supply chain agree that the
Proposed Rule raises serious questions about patient safety, cost and
access. That is why pharmacists, chain drug stores, distributors ,
pharmacy benefit managers, suppliers, healthcare advocacy groups, and
others are joining us and saying, 'we can do better,'"said Ralph G.
Neas, President and CEO of the Generic Pharmaceutical Association
(GPhA). "They recognize that by changing the FDA's long-standing
commitment to consistent labeling, this rule could have serious
unintended consequences. We are most concerned about the dangerous
confusion multiple labels would cause and the increased costs of and
reduced access to generic medicines for patients who need them most."
The letter was signed by the Academy of Managed Care Pharmacy (AMCP),
American Association of Colleges of Pharmacy (AACP), American
Pharmacists Association (APhA), American Society of Health-System
Pharmacists (ASHP), Amerinet, AmerisourceBergen, Cardinal Health,
Cardiovascular Research Foundation (CRF), CVS Caremark, Express
Scripts, H. D. Smith, Healthcare Distribution Management Association
(HDMA), Healthcare Supply Chain Association (HSCA), Mckesson, Corp.,
MedAssets, National Association of Chain Drug Stores (NACDS), National
Coalition on Health Care (NCHC), Novation, Pharmaceutical Care
Management Association (PCMA), Premier Healthcare Alliance, and
"Especially noteworthy are the associations representing more than
100, 000 pharmacists and more than 40,000 pharmacies who signed on to
the letter," said Neas. "No one understands better than pharmacists
the potential harm this proposed rule could engender. They are the 'on
the ground' trusted experts who dispense more than three billion
generic medicines that Americans use every year. The FDA should listen
carefully to their concerns."
The signatories call for FDA to consider the public health impact of
the draft rule. The letter reads: "The FDA and others need to fully
explore the potential unintended consequences that the rule may have
on patient access and national health care costs. Permitting labeling
changes for generic drugs without FDA approval counters 30 years of
law requiring generic and brand medicines to have the same labels."
The letter, addressed to FDA Commissioner Margaret Hamburg, also
points out the issue of potential liability for healthcare
practitioners, stating: "The Proposed Rule also may expose
pharmacists, physicians, generic drug manufacturers and others in the
health care system to substantial new tort liability costs; these, in
turn, would require generic manufacturers to adjust prices to stay in
business, withdraw products, or decline to launch new affordable
versions of brand medicines. This would have a chilling effect on the
ability of generic manufacturers and others in the pharmaceutical
supply chain to provide affordable medicines to millions of Americans
and people across the globe. This is the opposite effect that was
intended with the advent of generic medications."
The letter also pointed to the impact of the Proposed Rule on
healthcare system costs, citing a recent study by Matrix Global
Advisors. It showed that spending on generic drugs would increase by
$4 billion per year (or 5.4 percent of generic retail prescription
drug spending in 2012). Of this, government health programs would pay
$1.5 billion, and private health insurance, $2.5 billion.
The letter recognizes the need for a streamlined, efficient process
for updating safety information regarding the use of pharmaceutical
products for health care practitioners and the public, and ends on a
positive note, stating, "We believe that simple changes to the
proposed rule can achieve all of FDA's objectives related to efficient
communication of important safety information. At this critical
juncture, we look forward to working with you and all stakeholders to
identify a course of action that does not put patient safety or
patient savings at risk."
To read the letter, click here.
About GPhA GPhA represents the manufacturers and distributors of
finished generic pharmaceuticals, manufacturers and distributors of
bulk pharmaceutical chemicals, and suppliers of other goods and
services to the generic industry. Generic pharmaceuticals fill 84
percent of the prescriptions dispensed in the U.S. but consume just 27
percent of the total drug spending, saving the health system nearly
$200 billion annually. Additional information is available at
www.gphaonline.org. Follow us on twitter: @gpha.
Contact: Steve Arnoff, 202.249.7113
/Web Site: http://www.gphaonline.org
ST: District of Columbia
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0000 03/06/2014 14:46:00 EDT http://www.prnewswire.com
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