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Companies Struggle to Harness Business Intelligence

December 16, 2011 By Leave a Comment

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Business Intelligence (BI), the process of transforming the raw data companies collect from various operations and sources into usable and actionable information, is an often under-utilized and misunderstood tool in the strategic arsenal.

A new white paper from Information Builders by Kevin R. Quinn notes that companies are increasingly leveraging BI software to help them aggregate, manipulate, and display data to further inform their decision-making. Harnessed properly, this can improve the way companies do business if they utilize the proper business intelligence improvement cycle (BIIC).

But many companies fall short of their BI potential for several reasons, including:

  • Users’ skills and desires are misinterpreted.
  • An emphasis is put on the wrong stage of the cycle (plan, improve, measure, and analyze).
  • No information self-sufficiency.
  • No culture of established measurement.
  • Disparate tactical BI solutions gain footholds.

Let’s look a little more in-depth at how these common pitfalls trip up companies.
SKILLS MISINTERPRETED: There are four categories of information workers. Nontechnical business users, who tend to make up 80 to 90 percent of the workforce, business analysts, power users, and IT developers. Quinn says that too many organizations focus all of their BI resources and tactics on the business analysts and power users, this prevents “the majority of users from using the tools and becoming part of the information culture.”

WRONG EMPHASIS: Quinn argues that companies often neglect the first stage, planning or gathering information, in their haste to get to the good stuff. As the old computer adage goes, “garbage in, garbage out.” Planning and collecting information may not be as fun as working with the data, but it’s the foundation for the success of any big BI project.

LACK OF SELF-SUFFICIENCY: A common pitfall when setting the BIIC in motion is that the IT department is relied on as the sole information-producers in the company, while of course they aren’t the only group that generates data. “This causes an imbalance that leads to a heavier burden on IT because as more and more information consumers need information, more and more requests are made of IT.” Making matters worse, IT personnel frequently don’t understand the underlying nature of the business questions that data users are looking to answer, so their responses are often incorrect or incomplete in practical terms.

NO MEASUREMENT CULTURE: We’ve emphasized this before. If there is not buy-in at the top, any initiative is most likely going to fail. No exception here, Quinn says. “If executives are the only people who are about measurement and the improvement of those measurements’ outcomes, the motivation to improve will not be established among the ranks of workers who have the capability to make the necessary changes.”

DISPARATE SOLUTIONS: Quinn writes that many organizations purchase BI tools without a clear strategic plan for using them to truly make changes within the organization. When reports are generated at the behest of a Big Cheese, for example, rather than being part of a bigger BI plan, key reports and key information is often locked in figurative silos without contributing to a smooth-flowing BIIC.

Quinn advocates a simple method of information access and distribution along with open communication within an organization to ensure that everyone understands the value of BI and why an intelligent BIIC is a critical component of success in today’s marketplace.

Editor’s Note: To read the full white paper, click here. Note: Registration is required.

 

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Lilly CEO Calls on FDA to Lighten Up

November 8, 2011 By Leave a Comment

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

The FDA has to speed up adoption of a “Benefit-Risk Framework” to improve decision-making in the regulatory process, said John Lechleiter, Ph.D., chairman, president and CEO of Eli Lilly and Company.

Speaking at recent industry conference, the CEO of the drug giant called for a regulatory process that focuses both on recognizing and appreciating benefits while identifying and minimizing risks. Such a balanced approach would help increase the flow of needed medicines to patients and reverse a trend of fewer new drugs getting approved, he said.

“The stakes are high,” Lechleiter said. “The only way to make inroads against [chronic and other] diseases is to sustain the pace of medical progress.”

The FDA appears to be a bit on the defensive here. It recently issued a report touting its record approving drugs it says demonstrates it isn’t stifling innovation at all thank you very much.

The backdrop to this battle is the upcoming reauthorization of the Prescription Drug User Fee Act (PDUFA) V. Originally enacted in 1992, PDUFA and its iterations set the foundation for how FDA will manage the drug review process for five years, beginning in October 2012.

Lilly’s Lechleiter stressed the importance of a non-partisan course for reauthorization. “As a basis for the drug review process, PDUFA is too important to get bogged down in partisan politics,” Lechleiter said. “As Congress considers reauthorization next year, we hope to see a ‘clean’ bill – one free of extraneous and controversial provisions that would politicize the bill and further complicate matters for all parties.”Lechleiter said the regulatory system must continue to evolve to meet 21st century needs.

Lechleiter offered five key characteristics of a “state of the art” regulatory approval system:

  1. Timely – “There are far too many conditions for which therapy is inadequate or nonexistent. We need a system that is not only effective, but efficient as well.”
  2. Predictable – “The system must be predictable in its judgments, its decisions, and the criteria on which those decisions were based – whether scientific, ethical, legal, etc.”
  3. Consistent – “The system must be consistent across review divisions using standardization and repeatable processes – so that an innovator clearly understands the regulatory requirements and so that institutional learning can be harnessed to replace time-consuming one-off learning by review groups and division.”
  4. Transparent – “The system needs to be transparent in its judgments and criteria so [stakeholders] understand the rationale for its decisions.”
  5. Scientifically rigorous – “This requires scientific expertise within the agency – or access to the expertise – that understands, engages in, and influences the constantly evolving external scientific environment and ensures that standards are up-to-date.”

Lechleiter also discussed ways to strengthen a medicine’s benefit and lower its risk, including calling for greater emphasis on improved outcomes for individual patients, through the development of tailored therapeutics.

“From the point of view of patients and their doctors, a tailored therapy will provide a better benefit/risk trade-off, because they can have a higher degree of confidence that it will work effectively and with minimal harmful side-effects relative to the benefit obtained,” said Lechleiter. “From a value-for-money standpoint, tailored medicines should also reduce the heavy costs associated with non-responders. In other words, payers will get what they are paying for.”

Cry havoc and let slip the dogs of war. This one isn’t over by a long-shot.

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Filed Under: FDA Regulated, Michael Causey, Pharma/Biotech, Regulatory, Risk Management Tagged With: , , , ,

FDA Promises ‘Sea Change’ in Food Regulation

November 2, 2011 By Leave a Comment

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

The new mantra for food manufacturers better be prevention, prevention, prevention according to current and former FDAers commenting on the January 2011 passage of the mammoth Food Safety and Modernization Act.

“This law represents a sea [of] change for food safety in America, bringing a new focus on prevention…” FDA Commissioner Margaret Hamburg says.

But former FDA Commissioner of Foods Dr. David Acheson takes it further in a new white paper from Plex Online. The new law “will result in significant changes for FDA-regulated food manufacturers and processors.” FDA’s emphasis on prevention will require registered facilities to develop and maintain a written food safety plan, for starters, Acheson stresses in a new white paper “Food Safety plans: New Requirements for Registered Facilities.”

As we’ve blogged before, most registered food facilities will be required to develop a clear, detailed safety plan that documents the facility’s:

  • Prerequisite programs are in place to ensure food is produced in a safe and sanitary manner;
  • Hazard analysis that identifies all potential risks throughout processing;
  • Preventive controls that are implemented to mitigate risks;
  • Monitoring of preventive controls to ensure they are properly implemented;
  • Verification that the preventive controls have the intended reduction in risk; and
  • Re-analysis of the hazards and preventive controls when there are significant changes in the process or every three years.

Acheson, now with Leavitt Partners, notes that regulated entities must soon be “able to quickly access records and demonstrate compliance with the food safety plan requirements.” They’ll also be expected to have “implemented a robust food safety program” if they want to maintain a position as a food safety leader.

He advises regulated entities to develop well-documented safety plans with strong monitoring procedures and corrective actions, for nine key areas:

  1. Facility Information: Facilities will need to document a description of the food, the methods of distribution and storage, the intended use and intended customer for all products produced.
  2. Prerequisite Programs: These programs will require a written plan, established monitoring procedures, established corrective action procedures, and an established recordkeeping system.
  3. Hazard Analysis: Facilities will be required to conduct and document these to identify potential product-related hazards, including biological, chemical, and other hazards such as terrorism.
  4. Preventive Controls: Once identified, each hazard must be evaluated to determine the significance of the hazard if it isn’t controlled, the likely occurrence of the hazards, and if it constitutes a “critical control point” that must be addressed.
  5. Monitoring: Each critical control point must be then monitored to ensure compliance with the critical limits.
  6. Corrective Actions: Beyond on-going monitoring, facilities must establish and document procedures for taking proper and effective corrective actions when critical limits aren’t met.
  7. Verification: Facilities will then need to verify that the preventive control and critical limits result in the intended control and reduction of hazard.
  8. Record-keeping: The new legislation authorizes the FDA to request access to a regulated entities’ Food Safety Plan. Each entity must establish a record-keeping system that documents their hazard analysis, critical control points, monitoring, verification, and corrective action plans and follow-up.
  9. Re-analysis: facilities are required to conduct one of their food safety plan and hazard assessment whenever they implement significant changes or every three years.

It will take some time for the FDA to decide exactly how it will enforce the new law, and its interpretation will clearly have some impact on food manufacturers and other regulated entities. But it’s equally clear that the new law means big changes for companies that make food for a living.

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Filed Under: FDA Regulated, Food, Michael Causey, Quality Management, Regulatory Tagged With: , , , ,

Former FDAer: ‘Sweeping’ Food Regulations Will Challenge Entire Industry

October 20, 2011 By Leave a Comment

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

The most sweeping food regulation since the days of Franklin Delano Roosevelt is about to catch some unsuspecting companies off guard, warns former FDA Associate Commissioner of Foods Dr. David Acheson. “Companies need to update their compliance systems to meet a new mindset and new regulations,” he stressed.

The Food Safety Modernization Act, signed into law in January, will go into effect in stages in the next few years. The final rule is expected to be enacted in July 2012, with a ramp up time for companies to comply. It’s worth noting that, unlike its work with, say, 21 CFR Part 11 and eMDR, the FDA has in fact hit every regulatory deadline it has given itself. “That doesn’t give you very long to understand and navigate the change,” Acheson said.

But as with pharma and medical device industries, the bigger food companies tend to have a jumpstart in terms of compliance when compared with smaller companies, notes Plex’s Executive Vice President, Tom Mackey. Big companies had a hand in writing the law and are generally supportive of its provisions, he adds.

FDA, reacting to some high-profile recalls with cantaloupes, peanuts and other food products, is now preaching a mantra of “prevention, prevention, prevention,” Acheson said this week at a Webinar sponsored by Plex Online.

Acheson, now managing director food and import safety with Leavitt Partners, warned food industry players that “protecting the brand today is different than it was five years ago…and these new regulations are just icing on the cake.” New challenges for the food industry include higher consumer expectations and more aggressive social media that can damage a brand almost instantly.

We’re in a new world of global risk and supply chains, Acheson warned. Food companies that don’t get it, are going to get it from the FDA.

While he doesn’t expect FDA food inspections to increase for at least another year or two domestically, they are already on the rise internationally. He noted, too, that FDA inspectors today are focusing more on how well companies have a handle on CAPA and root cause analysis. “The FDA really expects you to understand what went wrong,” he said.

For example, in a typical inspection, an FDA inspector will now ask to see your food safety plan. He won’t read it cover to cover, but he will focus on a particular point, then ask you to demonstrate what’s gone wrong in your system in the last six months and ask you to show your root cause analysis capability, too.

“This is a great way to inspect, and the FDA has a heavy emphasis on verification and knowing that your plan is working,” Acheson said. All components must be continuously documented.

Oh, and expect more warning letters and recall notices, too, as a result of the Act and FDA’s new emphasis.

“It’s a heavy lift [to comply] but there are many ways to make it easier, including staying informed and using technological innovations” to get a better handle on your supply chain and your operations, he said.

But don’t get complacent just because you have some time before you need to comply, he suggested. Instead, use this time to get ahead of the curve.

Start by identifying a team in your firm to spearhead compliance, conduct a gas assessment, determine the best way to close those gaps, examine if your current business practices conform to these new regulatory demands, set priorities based on risk and resources, and establish a system to stay informed internally and one that can be used to demonstrate to FDA inspectors that you are on top of it.

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Filed Under: FDA Regulated, Food, Michael Causey, Regulatory Tagged With: , , , ,

Medical Device Industry Warily Eyes More FDA Reorganization Plans

October 10, 2011 By 1 Comment

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

That sound you heard last week was the device industry sighing and maybe even applauding lightly when the FDA announced  it was seeking the public’s input on a plan to identify and harness a web of outside experts who may help it speed device approval.

As Reuters reported, FDA formed a pilot committee of experts, which will run through December 30 and expand the pool of vetted sources the agency already has on tap. It’s all part of the FDA’s effort to reform the 510(k) medical device review process. Some say the agency isn’t tough enough in protecting the safety of device users; others say the agency is stifling innovation and sending more jobs overseas.

Device manufacturers we spoke to were guardedly optimistic about this and other recent FDA moves. “We support the creation of such a network, providing that the FDA ensures that the experts do not have any personal or professional ties or conflicts of interest with the products / manufacturers / specific device industries they oversee,” Kelly Roman, Vice President at Fisher Wallace Laboratories, told us.

“We are aware that current Panel members that the FDA works with on PMA and reclassification matters may have these types of ties and conflicts,” Kelly continues. “It is difficult to retain top experts who have no vested interest in the fate of the industries they oversee, but ensuring that the process is completely free of bias is essential to the FDA’s mission and to public health.”

She suggests that, as with Panel members, FDA should “provide the full professional biographies of network experts. “ She also called on the agency to provide a forum by which the public may raise concerns over potential conflicts of interest on a case by case basis, and provide some process by which these concerns are officially addressed.

“This will help provide transparency and resolution to conflicts of interest that will inevitably arise. As of now, there is no clear, prescribed way to address such issues.

But Charlie Chi, Ph.D., former CEO and co-founder of OtisMed (now part of Stryker Orthopaedics), is a medical device industry entrepreneur and inventor flat out thinks it’s a bad idea for the FDA to get involved in new medical technologies.

Chi doesn’t think any company would want the FDA to get involved in every step of the product development cycle. In addition, he thinks it would take longer and be more costly for companies to develop new medical devices even though the approval process might be faster.

Chi noted that most U.S. companies are now going to Europe/Asia first to launch their new products because the approval process is quicker and less stringent than in the U.S. Yet, the failure rate is actually less than here in the U.S. He thinks the FDA should follow a review and approval process similar to other countries around the world.

Doug Mowen

Doug Mowen, Accenture

Accenture’s Doug Mowen feels the pain of both sides and urged the medical device industry to take a “wait and watch” approach. “There has been so much noise around FDA and these issues, but I believe the FDA has now heard everyone loud and clear.” He and his team work with medical device firms to handle 483s and other FDA-related dealings.

Doug sees some reasons for optimism because the FDA does seem to finally understand the medical device industries concerns. “If the FDA is able to reform a few things in the 510(k) process and make it more transparent, that will be such a positive thing.”

With over 15 years of experience in the Life Sciences industry, Doug has worked broadly across the medical technology industry, assisting major MedTech companies with compliance in key areas including emerging markets, supply chain, and pricing and customer profitability. Most recently Doug developed a research paper “Achieving High Performance: Reinventing Medical Technology for a Dramatically Different Future,” addressing how global regulatory issues are changing the overall business landscape for MedTech.

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Filed Under: FDA Regulated, Medical Devices, Michael Causey, Regulatory Tagged With: , , , ,

FDA Reorganization Signals More Inspections for Drug, Device Firms

October 4, 2011 By Leave a Comment

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Under pressure from all sides, the beleaguered FDA keeps announcing new reorganization initiatives, name changes and all sorts of stuff that would be funny if it was scripted by the same team handling Steve Carell’s departure from “The Office” and the ushering in of the new James Spader era.

Unfortunately, in real life these things aren’t always so funny. The FDA has been mocked in many quarters for its failure to maintain a balance between protecting the public safety and encouraging innovation among device and drug companies.

The list of FDA reorg moves made in just the past year would fill pages of old-fashioned newsletter space, but suffice it to say that the FDA has made a lot of changes and shows no signs of stopping.

Question: Should device and drug manufacturers care?

Short answer: Yes.

Question: Do the FDA changes mean more inspections and enforcement action for device and drug manufacturers.

Short answer: Yes.

We’ve spoke with several drug and device company compliance officers in the past few months, and without exception we’re told that dealings with the FDA have become more time-consuming and frequent. Not surprisingly, none wanted to go on the record for fear of further irritating an already irritating (to them) agency.

“I didn’t like the FDA’s approach five years ago, but now I miss those days,” a mid-size device firm compliance officer recently told us, only half jokingly.

Areta Kupchyk

Areta Kupchyk, a partner and former FDA-er now at Reed Smith LLP, notes that “where FDA puts their resources typically reflects their priorities and approach to enforcement.  For example, FDA appears to be putting resources in enforcement areas and giving some of those divisions more independent authority from the chief counsel’s office to take action,” she tells us.

“FDA also wants to speed review times for 510(k) submissions, orphan drug designations, and therapeutic biologics (especially biosimilars).  The new acting Chief Counsel, Liz Dickinson, has a strong background in generic drugs and biosimilars and we are very likely to see more focus in this area,” Areta adds.

These FDA changes are mostly going to impact mid- and small-sized companies on the device side, Areta says. “Large pharmaceuticals already basically understand how compliance works and how to do it, but the mid-size device companies in particular don’t have enough experience with quality systems and GMPs,” especially as FDA’s interests and demands seem to keep changing.

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Filed Under: FDA Regulated, Medical Devices, Michael Causey, Pharma/Biotech, Regulatory Tagged With: , , ,

Medical Device Industry Skeptical FDA Training Initiative Will Do Much Good

September 15, 2011 By Leave a Comment

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Medical device companies are telling us off the record that they are not particularly optimistic about the FDA’s much ballyhooed new reviewer training programs it unveiled last week.

“If it makes reviewers act more consistently it will be positive but I think the problem is deeper,” a small medical device shop told us this week. Their products are mostly Class I but last year they began a Class II review process.

“Our reviewer left the agency in the middle, and the new guy asked a whole bunch of new questions and even questioned some of the old questions again,” the CEO told us.

His situation is not atypical, according to John Smith, Partner at HoganLovells.  His firm has represented over 500 medical device companies navigating the FDA review process. And what he’s seen isn’t pretty.

“It’s well known in the medical device world that depending on which FDA reviewer is assigned, you may get dramatically different results,” John told us. Like our small medical device shop CEO’s experience, John has also seen the review process change completely when one reviewer leaves and is replaced mid-process.

John’s also seen too many situations where similar Class II products get completely different treatment during their review. “That inconsistency is tough for industry to deal with,” he adds.

“It’s not uncommon for a new member [of the FDA review team] to raise new questions or even go back and look at areas the device company thought were already addressed” by the outgoing reviewer, John says.

CDRH chief Jeffrey Shuren has sometimes downplayed the impact of FDA turnover on the review process, but he generally concedes that the agency needs more help here.

The FDA’s current training initiative is not making any hearts flutter with happiness in medical device land, but John says it is a positive at least in the sense that “the FDA is right to identify this as an issue where resources should be directed.”

For John and others, the impact of this training initiative won’t be clear for months and maybe years. “It sounds like a worthwhile initiative, but we’d like to see the results,” he diplomatically says.  “It’s easy to identify the problem, let’s see if the FDA addresses it.”

But former FDA reviewer Patrick Stone says reviewers will keep leaving unless the agency makes some fundamental changes. “They never praise reviewers or give any positive feedback, and that’s why most reviewers can only take it there for about five years.”

The Senate is also expected to hold hearings in the Fall that will look at how good, or bad, the FDA’s current device review process is and how effectively it balances patient safety with spurring product innovation.

Summer’s over. Back to work.

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Filed Under: FDA Regulated, Medical Devices, Michael Causey, Regulatory Tagged With: , ,

Industry: FDA Policies are Raising Threat of Drug Shortages

September 15, 2011 By Leave a Comment

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

A sobering report from the American Society of Health-System Pharmacists (ASHP), the American Society of Anesthesiologists (ASA), the American Society of Clinical Oncology (ASCO), and the Institute for Safe Medication Practices (ISMP) highlights a serious and growing drug shortage problem in this country – and the FDA is one of the big problems, according to many in the drug industry.

“This is a national security and health risk conundrum,” says former FDA reviewer and now industry consultant (and fellow Assurx blogger) Patrick Stone.

“If the pill well runs dry on our seniors or high risk folks they may expire or degrade further in health,” Patrick worries. The FDA’s “GMP controls and tightly held batch quotas are a mess. QbD will add fuel to this fire by doubling the number of drugs that don’t make it to the shelves.”

A distressing article from Marginal Revolution raises further questions about why this is happening and FDA’s role in it. “Currently there are about 246 drugs that are in short supply, a record high. These shortages are not just a result of accident, error or unusual circumstance, the number of drugs in short supply has risen steadily since 2006. The shortages arise from a combination of systematic factors, among them the policies of the FDA.”

Stone’s take: “The FDA simply doesn’t understand how many drugs are impacted by its regulations.” He challenges the agency to track that, just as it tracks 483 violations and other issues.

Editor’s Note: Watch for a new Patrick Stone blog on this topic next week.

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Filed Under: FDA Regulated, Michael Causey, Pharma/Biotech Tagged With: , , , ,

FDA Boosts Training Program for Premarket CDRH Reviewers

September 13, 2011 By Leave a Comment

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

FDA just announced two new training programs it hopes will improve the consistency of medical device reviews by improving the skills premarket reviewers at the Center for Devices and Radiological Health (CDRH).

The Reviewer Certification Program, which began as a pilot in April 2010 with participants from CDRH’s Division of Anesthesia, General Hospital, and Infection Control and Dental Devices, will launch in September and will include all new device reviewers.

The program includes up to 18 months of training, aimed at complementing the skills and knowledge that new reviewers bring to CDRH from fields such as biomedical engineering and health care. Reviewers in the program will complete online training modules, instructor-led courses, and obtain practical experience in the medical device review process. Courses include medical devices, food and drug law and regulatory requirements, the CDRH review process, device design, and the impact of human factors.

“We are investing resources so that new device reviewers at CDRH are equipped to handle the range of issues that arise during the premarket device reviews,” said CDRH director Jeffrey Shuren, M.D. “This investment will improve the quality of submission review and make the process more consistent and predictable.”

FDA logoCDRH is also developing a pilot Experiential Learning Program for premarket reviewers. The program will include visits to academic institutions, manufacturers, research organizations, and health care facilities and is intended to give reviewers a better understanding of how medical devices are designed, manufactured and used. The program will also help new medical device reviewers understand the challenges of technology development and the impact of medical devices on patient care.

The Experiential Learning Program is in the design stage and scheduled to begin as a pilot program in 2012.

For more information: CDRH Plan of Action for 510(k) and Science

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Filed Under: FDA Regulated, Medical Devices, Michael Causey, Regulatory

IOM Report Calls for Gutting Current 510(k) Review Process, Angers Everyone

August 3, 2011 By Leave a Comment

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Tyra Banks aside, not many 35 year olds look as pristine and buff as they did in younger days.

But if the new Institute of Medicine (IOM) report has its way, the FDA’s 35 year-old 510(k) process should be put out to pasture entirely.

I suppose there’s something to be said for the fact that IOM’s controversial new report seems to have made almost everyone mad.

FDA is reportedly not happy and surprised that it calls for scrapping the current 510(k) system.

Stephen J. Ubl, president and CEO of the Advanced Medical Technology Association (AdvaMed), said industry isn’t happy with it, either. “The report’s conclusions do not deserve serious consideration from the Congress or the Administration. It proposes abandoning efforts to address the serious problems with the administration of the current program by replacing it at some unknown date with an untried, unproven and unspecified new legal structure. This would be a disservice to patients and the public health.”

Ulb goes on, “Numerous academic studies have shown that the 510(k) process is overwhelmingly safe. The IOM committee itself acknowledges that there is no evidence that the 510(k) process is failing to assure safety and effectiveness. Yet the report recommends entirely scrapping this proven process with a vague new plan that contains no useful guidance. It even goes so far as to say that further investment in 510(k) process improvements would not be ‘a wise use of FDA resources.”

But IOM’s report seems to have surprised everyone with its stark view of the situation.

“The committee concludes that the 510(k) process lacks the legal basis to be a reliable premarket screen of the safety and effective­ness of moderate-risk devices and, furthermore, that it cannot be transformed into one,” the report says.

IOM believes “the current 510(k) process is flawed based on its legislative foundation. Rather than continuing to modify the 35-year-old 510(k) process, the IOM concludes that the FDA’s finite resources would be better invested in developing an integrated premarket and postmarket regulatory framework that provides a reasonable assurance of safety and effectiveness throughout the device life cycle.”

In other words, junk it. Start over.

Has the FDA’s 510(k) process hindered innovation (as much of the medical device industry maintains), or has it struck the best balance between protecting patients and spurring new ideas?

Sorry, IOM punted on that one. “It is unclear—and the committee concludes that it is indeterminable, given current information— whether the 510(k) process over the last 35 years has had a positive or negative effect on innovation. To answer this question, the FDA should commission an assessment to determine this effect.”

In other words, do another study.

Respected industry attorney and Hogan Lovells Partner John Smith tells us, “the report is extremely disappointing given the time and effort that has been dedicated to this process. The assumptions underlying the IOMs conclusions are fundamentally flawed and those conclusions are vague and highly questionable.”

Specifically, he faults the IOM report for saying the 510(k) process does not evaluate safety and effectiveness. “This is simply not true in FDA’s application of the 510(k) paradigm to new medical devices. Although the standard for clearance is ‘substantial equivalence,’ the agency routinely integrates an evaluation of both safety and effectiveness into its substantial equivalence determinations. In other words, the IOM analysis lacks a ‘real world’ perspective and appears to have relied upon on a very conservative reading of the Federal Food, Drug, and Cosmetic Act, and its implementing regulations to reach this conclusion.”

IOM says scrap the 510(k) system, but some say scrap the IOM report.

“The Institute’s primary conclusion that the 510(k) process should be abandoned completely ignores the considerable debate that lead to its creation and the successful applicable of the 510(k) paradigm over 35 years,” Smith says. “No specific, systemic shortcomings that would justify such a radical restructuring were convincingly identified. Simply put, establishing the 510(k) paradigm was a thorough, thoughtful process and the process served both FDA and industry well since its inception. The Institute also fails to offer concrete recommendations as to potential alternatives, likely reflecting how difficult it will be to improve on the existing 510(k) paradigm.”

Watch the IOM’s webcast unveiling the report here.

Comment period ends September 30. To comment, go here:

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Filed Under: FDA Regulated, Medical Devices, Michael Causey, Regulatory Tagged With: , , , ,
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