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The FDA is requesting $4.03 billion to promote and protect public health as part of the fiscal year 2011 budget. This represents a 23 percent increase over the agency’s current $3.28 billion budget and includes a $146 million increase in budget authority and $601 million in industry user fees.

According to FDA Commissioner Margaret A. Hamburg, M.D. “The FY 2011 resources will strengthen our ability to act as a strong and smart regulator, protecting Americans through every stage of life, many times each day. This budget supports the ability for patients and families to realize the benefits of science that are yielding revolutionary advances in the life and biomedical sciences.”

The budget request reflects commissioner Hamburg’s resolve to transform food safety practices, improve medical product safety, protect patients and modernize FDA regulatory science to advance public health. This budget also funds FDA’s new regulatory authority over cigarettes and other tobacco products.

According to the agency, four initiatives are the major highlights for the FY2011 budget increases:

Transforming Food Safety (+ $318.3 million)
The Transforming Food Safety Initiative reflects President Obama’s vision of a new food safety system to protect the American public. The FDA will set standards for safety, expand laboratory capacity, pilot track and trace technology, strengthen its import safety program, improve data collection and risk analysis and begin to establish an integrated national food safety system with strengthened inspection and response capacity.

Protecting Patients (+ $100.8 million)
The Protecting Patients Initiative advances the Obama Administration’s priorities for safe, quality health care for all Americans. The resources in this initiative will support the safety of drugs, devices, and vaccines, as well as the Nation’s blood supply. The FY 2011 resources will also strengthen the FDA’s ability to act as a strong and smart regulator to address medical product safety challenges in the years ahead.

Advancing Regulatory Science (+ $25.0 million)
Advancing Regulatory Science builds on President Obama’s commitment to harness the power of science for America’s benefit. During the past two decades, extraordinary investments have led to revolutionary advances in the life and biomedical sciences. Many key discoveries, however, have yet to translate into real therapies for patients. The FY 2011 budget will allow the FDA to begin to strengthen its core scientific capacity. This investment will allow the FDA to identify improved pathways to product development and approval for new technologies that offer promising new opportunities to diagnose, treat, cure and prevent disease.

Tobacco (+ $215.0 million)
An increase in tobacco user fees will allow the FDA to continue to implement the Family Smoking Prevention and Tobacco Control Act. Preventing youth from using tobacco and helping Americans quit, promoting public understanding of the harmful constituents of tobacco products, developing the foundation of science for regulating tobacco, and regulating tobacco to reduce the toll of tobacco-related disease, disability and mortality are tobacco program priorities for FY 2011.

In our December 2009 article “What to Expect from FDA in 2010“ I stated that time would tell how the FDA’s current vision would affect industry and consumers. It is evident that through this budget request, Commissioner Hamburg is seeking the resources needed to achieve her vision for the FDA as a Public Health Agency. As she stated shortly after she took office, FDA’s role is to “Minimize Risks Through Education, Regulation, and Enforcement.”

The complete FDA FY2011 budget is available at: http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/BudgetReports/UCM199447.pdf

Healthcare providers are under more pressure than ever to improve clinical outcomes and reduce costs, while ensuring compliance with a myriad of applicable regulations. The proliferation of Medical Technologies has created a new level of complexity and risks for Healthcare organizations.

To meet these sometime divergent objectives, Healthcare providers must find ways to effectively manage a sophisticated mix of clinical, biomedical and facilities systems and equipment.

At the same time, healthcare administrators are looking for opportunities to maximize service delivery while managing the costs associated with these increasingly complex assets. Integrated Asset Management can help hospitals reduce costs, increase efficiencies and improve the quality of patient care.

To examine these issues and offer recommendations, IBM in cooperation with Axendia are proud to present a webcast entitled “Lower the Cost of Healthcare from the Inside Out”.

During this session, we discuss:

• Key business technology and regulatory trends facing the industry
• Ways to leverage the latest Asset Management solutions to improve care while controlling costs
• How healthcare organizations around the world have lowered the cost of healthcare from inside out using Asset Management solutions

To view this on-demand event, visit:
http://event.on24.com/r.htm?e=183331&s=1&k=E0A8E272CA5064F03BEDE54501F93BD5 

The FDA has initiated the process to amend its postmarket medical device reporting regulation (21 CFR Part 803) to require that manufacturers, importers, and user facilities submit mandatory reports of individual medical device adverse events, also known as medical device reports (MDRs) to the agency in an electronic format.

The Agency currently processed and analyses approximately 100,000 initial individual MDRs on a paper FDA Form 3500A. According to FDA figures, shifting to mandatory eMDR would improve it’s process for collecting and analyzing postmarket medical device adverse event information.

The proposed regulatory changes would also provide the agency with a more efficient data entry process that would allow for timely access to medical device adverse event information and identification of emerging public health issues. To support this, the proposed amendment to Part 803 includes modifications to the content of Form 3500A to better track information already required by FDA.

The implementation of the eMDR requirement is expected to reduce FDA annual operating costs by $1.25 million and generate industry savings of about $3.2 million.

The FDA has also issued a draft guidance document to assist industry and provide recommendations the preparation and submission of eMDRs in a manner that satisfies the requirements of the proposed regulation.

On January 26, 2010, Sparta Systems will be hosting a Seminar on eMDR at the Chicago Marriott O’Hare, in Chicago IL.

This seminar will address how medical device manufacturers can plan and prepare for a successful transition to electronic adverse event reporting. It will provide an overview and status report of the FDA’s Center for Devices and Radiological Health (CDRH) guidance, explore eMDR best practices and a successful eMDR implementation case study.

During the seminar, Axendia will provide an overview and status update on key initiatives driving FDA’s shift to eMDR. The discussion will cover background of the regulation and FDA guidance for eMDR implementation.

Ortho Clinical Diagnostics will discuss the challenges their company faced when planning for and designing transition to eMDR. They will then discuss best practices and lessons learned based on his successful eMDR implementation.

To learn more about this eMDR seminar and for registration information visit: http://www.spartasystems.com/media-center/seminars/preparing-for-emdr/

Adapted from an article published in MedicalDeviceSummit.com

FDA, like any other organization is comprised of people driven by collective goals, a mission and vision. The Agency’s mission is “protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.”

Whenever I have interacted with FDA officials, there is a palpable pride and passion for the Agency’s mission. As one FDA official commented during his remarks at Advamed 2009, “we certainly don’t do it for the money.”

The FDA’s role under President Obama is clear: “Minimize Risks Through Education, Regulation, and Enforcement.” (See report on the then newly appointed FDA Commissioner Margaret A. Hamburg, M.D., and FDA Principal Deputy Commissioner Joshua M. Sharfstein, M.D., and their vision for the Agency in June 9, 2009 article in Life-Science Panorama).

At recent industry events, we have seen clear evidence that this vision, as set forth by FDA’s new leadership, has been willingly embraced by personnel throughout the Agency. This was especially true of the “increased enforcement” theme.

During his keynote address at Advamed 2009, Dr. Sharfstein stressed: “the key challenge facing the Agency is credibility. The Commissioner will restore the Agency credibility with a three-pronged approach that will increase transparency, enforcement and integrity of scientific decisions.”

So what can we expect from FDA in 2010? I wish I could predict the future…
Nevertheless, based on the priorities and drivers set forth by FDA’s leadership, I provide my professional opinion:

• Higher morale and job satisfaction
• Increased regulatory enforcement
• New tools to enhance transparency
• Opportunities to challenge agency decisions based upon scientific data
• A drive to operate with the highest level of integrity

Time will only tell how the FDA’s current vision will affect industry and consumers. I look forward to providing you my thoughts and insights in 2010.

Seasons Greetings and Best Wishes for a Successful 2010

As part of the FDA’s transparency initiative, the agency seeks input from its constituents on whether inspectional observations reports (form 483) should be re-designed to make inspection findings available to the public quickly.

Form FDA-483 lists observations made during the inspection of a firm. Responding to Freedom of Information Act requests for 483s, often takes a lot of time due to the need to redact non-public information, such as trade secret and confidential commercial information, from the report.

The Agency is seeking to streamline the process required to make 483 findings available. To this end, FDA would like to re-design the inspection reports (483s) to include a summary or key findings page that could be made available to the public quickly. FDA would still review the full inspectional observation reports to redact any non-public information. 

To provide input to the agency on the re-design of Form 483, visit:  http://bit.ly/7ytaHG

What came first, the chicken or the egg?

In the case of FDA’s hearing on the “Promotion of Medical Products Using the Internet and Social Media Tools”, definitely the chicken.  FDA is using Internet and Social Media Tools to “stream” the hearing on the “Promotion of Medical Products Using the Internet and Social Media Tools” live on the internet (this is a circular sentence by design).

This is very refreshing and in line with Commissioner Hamburg’s vision to improve transparency at FDA.  The agency has made huge strides in recent months, with its transparency blog and official tweets.

You can view the live stream for the hearing by visiting http://bit.ly/4yWXip

The issue of networked medical devices has come from and center with two recent Life-Science Panorama articles focused on the topic.

“Hospitals & Medical Device Manufacturers Address Interoperability with New Standard“  by Oliver P. Christ, CEO Healthcare of PROSYSTEM AG discussed the emergence of standards and regulations around communications involving medical devices.

“Is Medical Device Interoperability Sufficient“  by Rick Schrenker, Systems Engineering Manager in the Massachusetts General Hospital Department of Biomedical Engineering, provides his perspective on interoperability standardization efforts and their impact on ensuring medical device safety and dependability.

Today, FDA issued a reminder to Medical device manufacturers, hospitals, medical device user facilities, healthcare IT and procurement staff, medical device users, biomedical engineers entitled: “Cybersecurity for Networked Medical Devices is a Shared Responsibility“ 

Through this vehicle, the FDA reminds the Medical Device community that cybersecurity for medical devices and their associated communication networks is a shared responsibility between medical device manufacturers and medical device user facilities. The proper maintenance of cybersecurity for medical devices and hospital networks is vitally important to public health because it ensures the integrity of the computer networks that support medical devices.

According to the article, FDA is aware of misinterpretation of the regulations for the cybersecurity of medical devices that are connected to computer networks. FDA’s interpretation of the regulations can be found in the 2005 guidance for industry and its accompanying information for healthcare organizations.
FDA wants to emphasize the following:

• Medical device manufacturers and user facilities should work together to ensure that cybersecurity threats are addressed in a timely manner.
• The agency typically does not need to review or approve medical device software changes made for cybersecurity reasons.
•  All software changes that address cybersecurity threats should be validated before installation to ensure they do not affect the safety and effectiveness of the medical devices.

Software patches and updates are essential to the continued safe and effective performance of medical devices. Typically, FDA approval is not required before installing changes, updates, or patches that address cybersecurity issues. Software patches usually do not involve FDA review because most patches are installed to reduce the risk of a cybersecurity problem and not to address a risk to health posed by the device.

The need to be alert and responsive to cybersecurity issues is part of the device manufacturer’s obligation. FDA recommends that purchasers and users of medical devices that may have a cybersecurity problem contact the device manufacturer with their concerns.

In the Reminder, FDA encourages the Medical Device ecosystem to take simple steps to help to protect against cybersecurity threats like viruses and worms that affect medical devices.

Last week, Karim Lokas, Vice President of Product Strategy for Camstar Systems, briefed me on the company’s acquisition of Technology Resources Group (TRG). A recognized leader in the Asia Pacific (APAC) region, TRG has expertise in manufacturing execution, equipment automation, manufacturing applications development, and program management for enterprise solution deployments. The acquisition is expected to accelerate the Camstar’s growth in the Greater China and Southeast Asian markets. This will place Camstar in an advantageous position to provide support for the growing number of global companies manufacturing and sourcing products in APAC.

However, TRG focuses primarily on Semiconductor, Solar and Electronics verticals. So why was I briefed?

Global Life-Sciences companies increasingly source and outsource to the APAC region. Yet a number of recent high-profile cases have focused Regulators and Manufacturers alike on the need to better manage and secure the global supply chain. (See “Pfizer and FDA Share Perspectives on Global Supply Chain Security“).

The sustained growth of Medical Product manufacturing in developing economies hinges on their ability to consistently provide products that meet the high quality standards that are expected by today’s global marketplace. Achieving this goal will require the implementation of systems and processes that provide real-time visibility, controls and situational-awareness around the corner and across the globe.

The combined services and support teams of Camstar in Asia will greatly enhance the firm’s ability to support the expected growth of medical product manufacturing in key APAC countries like China, India, Korea, Singapore and Malaysia.

Last month’s article in Life-Science Panorama entitled “Hospitals & Medical Device Manufacturers Address Interoperability with New Standard” discussed the emergence of standards and regulations around communications involving medical devices.  The article  offered what was to me a surprising claim:  “The use of these networked medical devices in a clinical context … will soon be subject to national or regional regulations [and] may not be marketed without evidence of interoperability, that is, they must not compromise the organization’s delivery of health care.” 

Having been involved with medical device interoperability standardization efforts for over a decade and watched approaches to the problem and players interested in it come and go as time went by, not much actually surprises me anymore.  But it’s quite a leap and a bit of a shock to go from “evidence of interoperability” to “[not compromising the] delivery of health care.”  Strictly speaking, interoperability is about the capability of devices to communicate with each other and make use of the shared data and nothing else.  Other properties will arguably play greater roles in assuring system integrity, e.g., reliability, usability, maintainability, availability, etc.  Interoperability is not synonymous with risk management, nor does it guarantee it. 

Still, I agree that draft standard IEC 80001 “Application of risk management to information technology (IT) networks incorporating medical devices” is expected to play a key role in assuring the system integrity necessary to realize the visions that interoperability is expected to enable.  But is IEC 80001 sufficient?

“I pose the following to clinical engineers and biomedical equipment technicians: “What would make you comfortable with supporting a request to implement aspects of critical care device functionality on an IT network?” Would being told that the network had been designed and installed according to relevant process and standards be sufficient? Or … evidence that the result of application of the processes and standards addressed functional and non-functional requirements relevant to critical care.   How much evidence do you need to support an argument that worst case failure of an ICU monitoring system … could not place a patient, or hundreds of patients, at unacceptably increased risk?” [1]

It is notable that that the risk management principles of IEC 80001 are largely inherited from IEC 14971, a more general and process-based medical device risk management standard that has primarily been applied to stand alone devices and system from single manufacturers. 

“Imagine the implications as medical devices increase their use of and dependence on networked resources, particularly in light of the rate of change and heterogeneity of clinical applications and systems implementations. This begs the question of whether anyone has examined, let alone established, the validity of extrapolating 20th-century medical technology development, assessment, and regulatory practices for the 21st-century healthcare system.” [2]

There is not enough space here to do justice to addressing the implications of the above, but for anyone interested I recommend the National Academies Press’ Software for Dependable Systems: Sufficient Evidence?, which argues:

“…the pursuit of dependability in software systems should focus on the construction and evaluation of evidence…software is guilty until proven innocent…This approach is…becoming standard in the world of systems safety, in which an explicit safety case…is  usually required… …a software system may not be declared “dependable” based
on the method by which it was constructed…Those claiming dependability for their software should therefore make available the details of their claims, criteria, and evidence…The willingness of a supplier to provide such data, and the clarity and integrity of the data that the supplier provides, will be a strong indication of its attitude to dependability”

In other words, for sufficiently complex technology, good process alone is insufficient to ensure safety and dependability.  So again I ask:  Granted that 80001 is necessary, but is it sufficient? 

1. R Schrenker, “Sufficient Evidence – Making the Case for Safety”, Biomedical Instrumentation and Technology, November – December 2008.
2. R Schrenker, “Learning from Failure – The Teachings of Petroski”, Biomedical Instrumentation and Technology, September – October 2007.

The opinions expressed in this article are those of the author(s) and do not necessarily represent those of Life-Science Panorama, its editor or Axendia, Inc.

Over the last few years, FDA has recognized the need to develop modern, well-integrated, reliable, efficient and affordable information infrastructure to support its administrative and regulatory business operations.  To this end, the Agency has embarked on a number of eTransformation initiatives. 

These initiatives promise to dramatically change interactions between the Agency and its primary constituents, Industry and the American Public.  FDA’s eTransformation initiatives will also affect the way Life-Science companies architect IT systems to store, manage and secure data.

The NetApp Pharmaceutical Roundtable will enable Life-Science Industry executives to network with their peers while learning about the latest FDA initiatives affecting their business and IT infrastructures.  The roundtable will feature a presentation by leading Life-Science industry analyst Axendia.

The event is scheduled for Thursday October 15th, 2009 at 6 p.m. and will be held at
The Frog and The Peach restaurant in New Brunswick, NJ.

For more information, and to register for this Roundtable, contact NetApp