For Pharmaceuticals:


Malcolm Bertoni Handles the Heat
Electronic Submissions, IT Changes Challenge FDA


Malcolm J. Bertoni is establishing the FDA?s strategic vision for transforming regulatory operations, with its emphasis on the importance of electronic submissions. This is a hot topic for his department and for the life sciences industry.

Where’s the hot spot at the Food and Drug Administration these days?  With product recalls, new hires at top levels and an impending election, there’s more than enough sizzling seats to go around at the Agency.  

Malcolm J. Bertoni, Acting Assistant Commissioner for Planning in the FDA’s Office of Policy, Planning and Preparedness, handles plenty of heat in his department.  This soft-spoken administrator is in the middle of establishing the FDA’s strategic vision for transforming regulatory operations, with its emphasis on the importance of electronic submissions. He’s a leading member of the FDA’s Bioinformatics Board, responsible for coordinating and overseeing all activities related to business automation planning, acquisition, and implementation decisions throughout FDA. Finally, he’s chairing the Pre-Market Business Review Board, which oversees many of the IT enhancements proposed under the Prescription Drug User Fee Act reauthorization (PDUFA IV).

Electronic Submissions Pivotal
Electronic application submissions are among the biggest FDA-related topics in the pharmaceutical and medical device fields today.  How to format these submissions and a deadline for requiring electronic submissions affects a tremendous number of businesses.

At the moment, there’s no specific timetable for forcing all submissions to become electronic, says Bertoni,.  “FDA is asking for stakeholder opinions on requiring submissions to become totally electronic,” he says.  “This is an area that’s getting a lot of attention.  I think everyone agrees that the goal is to get to a place where we use a standards-based approach for electronic submissions. FDA is working with a broad range of stakeholders to do this in feasible time frames that are not burdensome.”

Bertoni thinks electronic submissions are important for a number of reasons, not the least of which is public health.  Electronic submissions speed to the open market drugs and devices the public needs.  “From a public health standpoint, it’s important that we get to the point where there is less time spent managing paper and more time spent reviewing the content of submissions,” he says.

How these submissions will be formatted is also of concern.  “The Regulatory Product Submission (RPS) standard is the wave of the future,” Bertoni comments.  “It takes the current standards and provides more flexibility and administrative capabilities. The FDA is committed to working through the International Council on Harmonization (ICH) and Health Level 7 (HL7) international standards organizations as we move forward.  The HL7’s RPS standard is designed to cover all product areas that FDA regulates and we want to move toward it. We’ll honor our ICH commitments to the electronic Common Technical Document (eCTD) format, but RPS is a technological advance.  As is often the case, we’re faced with a tradeoff between maintaining a standard and  seizing an opportunity to advance technology.  Fortunately, in this case we’re seeing a convergence of thinking as eCTD evolves toward the RPS approach.”

Improving Quality of Submissions
Bertoni has received enough feedback from stakeholders about electronic submissions to recognize that industry wants to know how to improve the quality of submissions.  “FDA wants to be clear about recommendations for improvement and industry needs to follow these recommendations,” he says. 

“The general recommendation is for industry to open up a dialogue with the FDA and the people who handle submissions.  Work with them as you begin to build a submission and get feedback along the way.  Those who are most successful tend to open up a dialogue about technology information exchange with the submissions experts. We’re happy to run tests with industry to help them improve the technical submission aspects of their submissions.”

“In fact, we encourage submitters to test their submissions as early as possible so we can help them improve a process.  There’s a page on the FDA website—US FDA Electronic Submissions Gateway (ESG) ---that provides information about how to execute an electronic submission.  This is a good resource for people working with electronics submissions, whether they are doing it for the first time or as experts.”

“The day of all-electronic submissions is coming,” he adds. “We want people to voluntarily comply with the electronic submission standards that currently exist and plan for the new ones yet to be established.”

Strategic Plans for IT Governance
In the next six months, Bertoni and his staff will be working with the Bioinformatics Board and the Office of the Chief Information Officer on strategic plans for information technology within FDA.  He says that just like many biotechnology companies, FDA needs to clean up and reorganize the way information is stored and handled.

He says his office is dealing with several challenges facing FDA’s IT governance:

  • Given that
    • FDA is a scientific information agency
    • FDA’s scientific data and information is currently decentralized
    • FDA’s Centers and major Offices have developed independent IT systems
    • Much of FDA’s IT infrastructure is aging and frail
    • The automation currently planned will be expensive
  • FDA has concluded that they can more effectively and efficiently manage their resources by taking an enterprise-wide approach to IT planning and assessment.

“There’s a lot going on agency-wide to improve IT infrastructure,” he says.  “In addition to improving our physical assets, we’re laying out processes for developing standards and laying out broad timelines for the direction we’re taking.”

“In terms of actual building of capabilities, over the next 12 months we’ll make sure we’ve done enough planning to make sound investments and build the capabilities we’re going to need for the future.  We’re building a data center at FDA’s new campus at White Oak that will provide more efficiency and take us to a common platform to support bioinformatics computing needs.  We also are planning to consolidate our electronic documentation rooms.”

Bertoni lists five benefits to patients, industry and FDA from these IT investments:

  • Improved public health through better information and analysis
  • Improved productivity and efficiency
  • Greater consistency across FDA
  • More predictable technology improvement path
  • Improved harmonization with international standards

“We are definitely trying to aim before we shoot,” he says.  “We’re mostly in the planning and decision-making stage this year; we’ll execute our plans in the following four years.”

“FDA will be making the transformation from paper systems to electronic systems as a progression toward e-government,” he continues.  “This is an important public health goal because FDA sits on a tremendous repository of clinical trial and health information.  If we’re able to move this information into databases that allow us to do data mining and analysis, we’ll be able to improve how we do product safety evaluations.  This will help us improve product safety across the entire life cycle of a product, so public health benefits.  Achieving this transformation to e-government is important to the evolution of the FDA.”

Industry Participation Crucial
Bertoni acknowledges that this transformation may be disruptive to FDA and industry employees.  “We see the opportunity for greater efficiency and similarities in working across the Agency and across scientific boundaries,” he says.  “We’re seeing how we can migrate to agency-wide solutions and still tailor our work to meet individual program needs through technologies that are already common on the Internet and in e-commerce.  We want to see how to make our cross-Agency e-submission initiatives work best for the FDA and industry without disrupting both groups’ daily activities.”

“We know that industry needs time to adapt to the new standards we’re establishing,” he continues.  “We need to proceed at an appropriate pace that is reasonable and affordable for our stakeholders.”

Public discussions will be held during this IT transformation, he says.  “We have to talk to a wide diversity of stakeholders during this change.  We know small start-ups don’t have large IT resources at their disposal and we need to be aware of how our standards will affect them.  We’ll look at various business models and approaches to make sure that affordable services are available to these companies.”

He encourages everyone to participate in these public discussions, whether in person or online.  “We want everyone to stay aware of the changes happening in electronic submission policy.  We’re on the verge of a big change in the way information is captured, stored and transmitted.  It’s very important to our IT planning that the full spectrum of our stakeholders participates in the public forums. When we submit the draft of our proposed IT plan for PDUFA at the end of 2007, we want feedback.  We want to hear opinions from businesses large and small. Participation will be a very big key to the success of the IT transformation.”


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