Groups Highlight Need for Hard Look at Patient Safety, Access, Cost, and Supply Chain Ramifications

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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 Follow us on twitter: @gpha.

Contact: Steve Arnoff, 202.249.7113


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