|By PR Newswire||
|January 29, 2014 12:32 PM EST||
WASHINGTON, Jan. 29, 2014 /PRNewswire-USNewswire/ -- "In last night's State of the Union address, President Obama said, 'Today in America… [a]rural doctor gave a young child the first prescription to treat asthma that his mother could afford,' vividly capturing the critical importance of access to safe, affordable medicines for our nation's patients and our health care system.
Indeed, in the 30 years since the enactment of the enormously successful Hatch-Waxman law in 1984, which struck a balance between competition and innovation in the pharmaceutical marketplace, generic utilization has now grown to be 84% of medicines dispensed. This success has generated savings for the U.S. health system of $217 billion in 2012 and $1.2 trillion over the most recent decade, according to the fifth annual Generic Drug Savings in the U.S. report, compiled by IMS Health on behalf of GPhA.
And it all rests on the foundation of the Food and Drug Administration's (FDA's) approval of generic medicines as scientifically equal to the brand medicine in drug safety, efficacy and quality. As the preeminent public health agency in the world today, doctors and consumers can rely on the FDA's determination of sameness to be confident in generic drugs.
Unfortunately, the FDA's current Proposed Rule on Labeling would undermine the Hatch-Waxman Act and put both patient safety and health care savings at risk, according to a new GPhA white paper on the topic.
As drafted, the proposed rule would create substantial confusion for pharmacists, doctors, nurses, patients and others in the health care system by allowing for multiple, different drug labels in the market for the very same product, upending 30 years of law and regulation. This would not only jeopardize patient safety, but would also cause billions of dollars in increased costs for consumers, taxpayers, large and small businesses, and state and federal governments. The rule would decrease patient access, impede healthcare decisions and delivery, and make fewer generic drugs available.
The sustainability of our health care system, indeed our national economy, depends on the continued access to safe, effective, more affordable generic medicines in a timely manner as envisioned under Hatch-Waxman. Patients and healthcare practitioners must continue to have access to consistent, transparent information in order to best inform treatment decisions. The generic pharmaceutical industry will continue to work with the FDA and other stakeholders to make sure that any changes to labeling rules and regulations protect patient safety, align with federal laws, and do not hinder patient access to more affordable generic medicines.
At a time when all stakeholders and patients are adjusting to the new realities of the Affordable Care Act, we should seek to limit provider confusion about generic prescribing. Unfortunately, the current FDA proposed rule on generic labeling does just the opposite."
For detailed analysis on the impact of the FDA proposed rule, read the new GPhA white paper:
About the Generic Pharmaceutical Association
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. Additional information is available at www.gphaonline.org. Follow us on twitter: @gpha
Contact: Steve Arnoff
Generic Pharmaceutical Association (GPhA)
SOURCE Generic Pharmaceutical Association
The 17th International Cloud Expo has announced that its Call for Papers is open. 17th International Cloud Expo, to be held November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA, brings together Cloud Computing, APM, APIs, Microservices, Security, Big Data, Internet of Things, DevOps and WebRTC to one location. With cloud computing driving a higher percentage of enterprise IT budgets every year, it becomes increasingly important to plant your flag in this fast-expanding bu...
Jul. 4, 2015 09:30 AM EDT Reads: 776
The 5th International DevOps Summit, co-located with 17th International Cloud Expo – being held November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA – announces that its Call for Papers is open. Born out of proven success in agile development, cloud computing, and process automation, DevOps is a macro trend you cannot afford to miss. From showcase success stories from early adopters and web-scale businesses, DevOps is expanding to organizations of all sizes, including the ...
Jul. 4, 2015 09:15 AM EDT Reads: 762
Internet of Things is moving from being a hype to a reality. Experts estimate that internet connected cars will grow to 152 million, while over 100 million internet connected wireless light bulbs and lamps will be operational by 2020. These and many other intriguing statistics highlight the importance of Internet powered devices and how market penetration is going to multiply many times over in the next few years.
Jul. 4, 2015 09:00 AM EDT Reads: 2,286
Today air travel is a minefield of delays, hassles and customer disappointment. Airlines struggle to revitalize the experience. GE and M2Mi will demonstrate practical examples of how IoT solutions are helping airlines bring back personalization, reduce trip time and improve reliability. In their session at @ThingsExpo, Shyam Varan Nath, Principal Architect with GE, and Dr. Sarah Cooper, M2Mi’s VP Business Development and Engineering, will explore the IoT cloud-based platform technologies drivi...
Jul. 4, 2015 09:00 AM EDT Reads: 1,296
WebRTC converts the entire network into a ubiquitous communications cloud thereby connecting anytime, anywhere through any point. In his session at WebRTC Summit,, Mark Castleman, EIR at Bell Labs and Head of Future X Labs, will discuss how the transformational nature of communications is achieved through the democratizing force of WebRTC. WebRTC is doing for voice what HTML did for web content.
Jul. 4, 2015 08:45 AM EDT Reads: 947
DevOps Summit, taking place Nov 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 17th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. The widespread success of cloud computing is driving the DevOps revolution in enterprise IT. Now as never before, development teams must communicate and collaborate in a dynamic, 24/7/365 environment. There is no time to wait for long development...
Jul. 4, 2015 08:45 AM EDT Reads: 897
To many people, IoT is a buzzword whose value is not understood. Many people think IoT is all about wearables and home automation. In his session at @ThingsExpo, Mike Kavis, Vice President & Principal Cloud Architect at Cloud Technology Partners, discussed some incredible game-changing use cases and how they are transforming industries like agriculture, manufacturing, health care, and smart cities. He will discuss cool technologies like smart dust, robotics, smart labels, and much more. Prepare...
Jul. 4, 2015 08:30 AM EDT Reads: 1,018
"Plutora provides release and testing environment capabilities to the enterprise," explained Dalibor Siroky, Director and Co-founder of Plutora, in this SYS-CON.tv interview at @DevOpsSummit, held June 9-11, 2015, at the Javits Center in New York City.
Jul. 4, 2015 08:00 AM EDT Reads: 1,309
Overgrown applications have given way to modular applications, driven by the need to break larger problems into smaller problems. Similarly large monolithic development processes have been forced to be broken into smaller agile development cycles. Looking at trends in software development, microservices architectures meet the same demands. Additional benefits of microservices architectures are compartmentalization and a limited impact of service failure versus a complete software malfunction. ...
Jul. 4, 2015 07:30 AM EDT Reads: 1,196
Explosive growth in connected devices. Enormous amounts of data for collection and analysis. Critical use of data for split-second decision making and actionable information. All three are factors in making the Internet of Things a reality. Yet, any one factor would have an IT organization pondering its infrastructure strategy. How should your organization enhance its IT framework to enable an Internet of Things implementation? In his session at @ThingsExpo, James Kirkland, Red Hat's Chief Arch...
Jul. 4, 2015 07:00 AM EDT Reads: 1,001
17th Cloud Expo, taking place Nov 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA, will feature technical sessions from a rock star conference faculty and the leading industry players in the world. Cloud computing is now being embraced by a majority of enterprises of all sizes. Yesterday's debate about public vs. private has transformed into the reality of hybrid cloud: a recent survey shows that 74% of enterprises have a hybrid cloud strategy. Meanwhile, 94% of enterprises ar...
Jul. 4, 2015 06:00 AM EDT Reads: 817
SYS-CON Events announced today that Secure Infrastructure & Services will exhibit at SYS-CON's 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. Secure Infrastructure & Services (SIAS) is a managed services provider of cloud computing solutions for the IBM Power Systems market. The company helps mid-market firms built on IBM hardware platforms to deploy new levels of reliable and cost-effective computing and hig...
Jul. 4, 2015 03:00 AM EDT Reads: 823
IT data is typically silo'd by the various tools in place. Unifying all the log, metric and event data in one analytics platform stops finger pointing and provides the end-to-end correlation. Logs, metrics and custom event data can be joined to tell the holistic story of your software and operations. For example, users can correlate code deploys to system performance to application error codes. In his session at DevOps Summit, Michael Demmer, VP of Engineering at Jut, will discuss how this can...
Jul. 3, 2015 07:00 PM EDT Reads: 954
"AgilData is the next generation of dbShards. It just adds a whole bunch more functionality to improve the developer experience," noted Dan Lynn, CEO of AgilData, in this SYS-CON.tv interview at 16th Cloud Expo, held June 9-11, 2015, at the Javits Center in New York City.
Jul. 3, 2015 05:00 PM EDT Reads: 974
The basic integration architecture, as defined by ESBs, hasn’t changed for more than a decade. Most cloud integration providers still rely on an ESB architecture and their proprietary connectors. As a result, enterprise integration projects suffer from constraints of availability and reliability of these connectors that are not re-usable across other integration vendors. However, the rapid adoption of APIs and almost ubiquitous availability of APIs amongst most SaaS and Cloud applications are ra...
Jul. 3, 2015 04:45 PM EDT Reads: 894