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One of the last remaining perks of a transcontinental flight is the ability to put on a set of noise cancelling headsets, listen to your favorite tunes and read through a hefty 600 plus page volume. I chose the 604 page Fiscal Year 2011 Food and Drug Administration Justification of Estimates for Appropriations Committees.

As I ploughed through this “engaging material”, I noticed that FDA’s 2011 Budget Justification includes a 400 Million Dollar investment in information technology (IT). Through this funding, FDA will continue to expand the adoption of Agency-wide systems supporting the transformation of nearly every aspect of Agency operations and regulatory duties.

The budget justification identified the following Agency-wide systems for use by ALL FDA centers and offices:

Regulated Product Submission (RPS) will provide a standard framework for receiving regulatory information using predefined parameters for the more efficient identification and cataloging of submitted information.

Janus will establish FDA-wide data architecture and standards that will ultimately convert and store scientific data from external and internal sources into a structured format that can be used throughout FDA.

The Common Electronic Document Room (cEDR) will establish a single, FDA-wide repository for all FDA-regulated documents and provide an end-to-end electronic environment from the receipt of product pre-market application information through its review, approval, and post-market surveillance to achieve a more efficient review and surveillance process.

Harmonized Inventory (HI) will provide a complete and reliable inventory of firms, facilities, products, and components/ingredients, as well as their relationships and points of contact for all FDA regulated products.

MedWatch Plus will provide an integrated system for receiving, processing, storing and analyzing adverse event reports and other safety information for all FDA regulated products.

FDA Advisory Committee Tracking and Reporting System (FACTRS) will provide a fully electronic system to support advisory committee meetings and management of meeting information, people, and reporting capabilities.

 As we revealed in Axendia’s “FDA e-Transformation” whitepaper, the agency is implementing 21st century IT systems and infrastructure. This modernization will create a robust foundation to enable interoperability of regulatory data and support information sharing across the FDA centers and program areas. Shared systems will support agency-wide activities ranging from pre-market review for all regulated products to post-market surveillance, including adverse event detection and future scientific computing capabilities.

Are you ready for the 21st Century FDA?

Last week, FDA Commissioner Dr. Margaret Hamburg formally announced the deployment of PREDICT–the Predictive Risk-Based Evaluation for Dynamic Import Compliance Targeting.

“PREDICT is an exciting innovation that harnesses advances in information science to enable us to do our job better and to improve our service to the nation” said Dr. Hamburg. “But it is just one step. More broadly, we are moving from a system that places most of the regulatory burden on the FDA’s modest inspection force, to one that creates greater oversight at points further back along the production chain” she added.

The system was piloted in Los Angeles and is currently going online in New York. FDA’s targets to have PREDICT up and running around the country by late Spring 2010.

PREDICT is a sophisticated information technology system developed for use by border inspection operations. The system allows FDA inspectors to monitor products at the port of entry more reliably and to target shipments for inspection that pose the greatest risk.  It utilizes Analytics and Business Intelligence tools to rank product shipments according to risk. Based on these assessments, it decides which shipments should be checked upon arrival.
The System enables FDA inspectors to spend more of their time looking at the highest-risk items. PREDICT will by automatically flag potentially risky shipments as well giving lower risk scores to materials that are more innocuous and those products with good FDA compliance histories.

To make these decisions, PREDICT takes into account information on:

• Product manufacturer
• Manufacturing site location
• Inspection site of manufacturing facilities
• Manufacturer’s level of supply chain accountability
• Criticality of final products marketed

This is especially important give that FDA-regulated products marketed in the US are manufactured in more than 300,000 foreign facilities in over 150 countries around the globe.  This year, nearly 20 million shipments of food, devices, drugs, and cosmetics will arrive at U.S. ports of entry.

“I can assure you that addressing the problem of global supply chain safety, and shifting the existing paradigm from reaction to prevention, is one of my highest priorities for FDA”  said Hamburg. “Refining our understanding of the problem and exploring and assessing possible solutions will be a major focus of our work over this next year and well beyond.”

As we identified in our “FDA eTransformation Initiatives” research study, the Agency is making significant investments in Information Technology to support its mission. PREDICT is another leap forward on FDA’s shift from a model that places most of the regulatory burden on its inspection force, to one that creates greater oversight further back along the supply chain.  The use of Analytics, Business Intelligence and Information Technology takes FDA’s “Risk Based Approach” to a higher level.

See a video of PREDICT in action

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.