Numbers don’t lie. Reviewing the year-end numbers for FDA’s CDRH electronic submissions (AS2 Electronic Submissions Gateway) provides some eye popping stats.  This is an early indicator that electronic medical device reporting submissions have significantly increased over 2008, and certainly suggests they’ll rise even faster this year after the final rule is published.

Comment period on the draft guidance ended November 2009. The final ruling is expected within weeks. According to some FDA insiders, many were relieved the agency wasn’t overwhelmed with comments (slightly over two dozen comments were filed), and the ones received were definitely “workable”.

So, what did 2009 numbers look like?

As the chart shows, early 2009 got off to a slow start, but picked up significantly in the fourth quarter of the year.

But when comparing 2008 vs. 2009, total submission numbers jumped from 4,619 to 21,296. It’s apparent that the device industry has picked up the pace when it comes to electronic submissions to FDA. And if this isn’t a wake up call for device companies to move away from paper 3500A submissions to eMDR, we don’t know what is.

We’ll be keeping a close eye on this through 2010.

The early part of the 21st century was a tough time for the FDA. Its budget was curtailed, it lost some important personnel, and the word “acting” kept appearing on people’s business cards.

But 2009 just might be going down in history as the Year of the FDA Turnaround.

In October, the agency announced a long-overdue hiring binge that signals an even stronger FDA is on tap for 2010.

Watch for the agency to get a bigger budget in the coming years – though much of that emphasis will be on the food side and perhaps less on the drug and device side. For FY 2010, the FDA requested a total budget of $3.2 billion. This amount is $511 million more than FY 2009 and represents a 19 percent increase — the largest ever in FDA history. They won’t get it all, but they’ll probably come close.

Here are some other FDA highlights in a big year:

FDA Finally Gets Tobacco

It took years of lobbying and a new President, but in June 2009 the FDA was given the power to regulate tobacco products. This is a huge victory for the agency. It remains to be seen how the FDA will use this new power, but its surge of activity in the second half of 2009 suggests they want to seize the initiative.

Lawrence Deyton, M.S.P.H., M.D., joined the U.S. Food and Drug Administration (FDA) on Sept. 14, 2009, as director of the agency’s new Center for Tobacco Products. He hit the ground running.

“Our objective is to use the best available science to develop and put into action effective public health strategies to reduce the enormous toll of illness and death caused by tobacco products,” Deyton said .

Deyton was also asked how the tobacco regulation differs from FDA’s regulation of drugs or medical devices?

“FDA’s regulatory role for drugs and medical devices is usually based on a safety and effectiveness standard. The tobacco act establishes a new standard: to regulate tobacco products based on a public health and population health standard.

Deyton noted that when FDA gets an application for a new drug to treat a disease, the agency normally considers studies of patients who have the disease. ”But when we get an application for a new tobacco product, the law tells us we have to consider whether permitting the product’s marketing protects the public health and we have to evaluate the effects of the product on the population as a whole. We’re directed to consider both users and nonusers, and whether our action might encourage people who don’t use tobacco products to begin using them, or encourage people who might otherwise quit to continue using them.”

Bottom-line: It was a huge turf battle victory for the FDA and increases the agency’s overall regulatory clout.

Risk Communications

The agency also took big strides forward in how it gets the word out to industry and the public regarding risk. In its Strategic Plan the agency spelled out its perceived role in communicating the risks of regulated product use, defining risk communication anew for a 21st century in which evolving technologies have enabled increased patient and consumer involvement in managing their health and well-being. The document defines the three key areas (science, capacity, and policy) in which strategic actions, in collaboration with relevant domestic and international stakeholders, can improve the generation, dissemination, and regulation of risk communication about regulated products. It also identifies and details 14 specific strategies.

“FDA is showing its commitment to the goals of the plan not just by identifying the strategies it will implement, but also by identifying over 70 actions the agency plans to take within the next few years to improve risk communication,” it says in the Strategic Plan. The document also identifies 14 of those actions that FDA plans to accomplish within the next 12 months.

Clearing Up Transparency

Echoing an Obama campaign promise to make government more open and accountable to taxpayers, the FDA also walked the walked and talked the talk with its new “transparency”  initiative with public meetings in June and November. The agency also opened a blog that, so far, has had a fair amount of uncensored comment both pro and con about agency performance.

Here (Finally) Comes the eMDR Guidance

In August, the FDA unveiled their proposed guidance for ultimately mandating electronic submission of mandatory adverse event reports. It took a long time to come to fruition, and some are lobbying the agency to push it back another year or two, but the simple fact that it was released was a big deal in 2009.

Guidance on Presenting Risk Info

Before unveiling the eMDR rule, the agency also issued  in May the important draft Guidance for Industry: Presenting Risk Information in Prescription Drug and Medical Device Promotion. The guidance is important on several levels, but perhaps the most important is that it addresses factors the FDA considers when evaluating ads and promotional labeling for prescription drugs, ads for restricted medical devices, and promotional labeling for all medical devices for their compliance with the Federal Food, Drug, and Cosmetic Act and relevant regulations.

In doing so, it cleared up a lot of confusion in the industry and signaled a revitalized FDA that was on the way back.

Putting The ‘Food’ Back In Food & Drug Administration

Responding in part to pressure from Congress and consumer groups over beef and other food contamination recalls, the FDA also revitalized its food enforcement in 2009, and this is also an area where the smart money says they’ll be even more active in 2010. In September, the agency capped a number of new food initiatives by unveiling a new reporting system that gives the agency new enforcement teeth when it comes to the food chain.

Here’s a prediction: FDA historians of the future are probably going to see 2009 as the year the agency picked itself up off the ground and started to flex its regulatory muscle again.

Well, the eMDR comment period has come and gone – and I’ve got to say I’m a little surprised at the relatively low number of comments. But let’s look on the bright side: What we didn’t get in quantity we might have gotten in quality. This is generally as well-articulated and intelligent a group of comments I’ve read in years.

The overall tone of the letters can be summed up like this: Some want more time to implement the rule, while most generally support the eMDR initiative and call for some changes, mostly of a relatively minor, if probably justified, nature.

A few days before the comment period ended, I spoke with Axis Technology President Mike Logan about why there were so few comments. A handful came in after we spoke on Nov. 11, but he and I are still both a bit surprised there weren’t ultimately more comments.

His view:  “Right now I believe people are taking a ‘wait and see’ approach until more firm details are unveiled. As nice of an idea the eMDR is, there are a lot of risks involved and questions that need to be answered, such as how this impacts standards compliance and potential liabilities.” Axis is a provider of IT consulting and data security offerings for healthcare industry organizations.

Some of the comments seek the kind of clarification Logan believes some in industry need before they are fully confident in using eMDR.

From a medical device standpoint, AdvaMed’s comment is one of the most important since it speaks for so many others (its member companies produce nearly 90 percent of the health care technology purchased each year in the U.S.). It’s also worth noting that the trade association can “get away” with saying things to the FDA that an individual company might not want to risk.

At the outset, AdvaMed says it supports the initiative. But, and there’s always a but in cases like this, they want to see the time stamp issue clarified, a concern echoed by Abbott. AdvaMed also wants the agency to adopt the date and time in the first acknowledgement sent to the submitter by the FDA that the report was received. It also wants the agency to develop a grace period for companies when they have a system outage, among a few other requests.

AdvaMed also wants the final rule to take effect at least two years after publication of the final rule.

On balance, most of the changes requested by the comment letters strike me as reasonable. Industry won’t get everything it asks for here, but I suspect the FDA will work pretty hard to accommodate the most reasonable requests.

Remember, the agency is still smarting from how it mishandled 21 CFR Part 11 in 1997. Back then, it made the rule way too literal and hands-on. Its stated goal to was to advance the use of technology; instead the FDA set it back for several years.

In many ways, I think the agency is to be commended for learning from its mistakes with Part 11 and applying them to its rollout of eMDR. The eMDR guidance is not perfect for everyone, but it’s pretty good for almost all, and that kind of effective compromise strikes me as democracy at its best. Here’s hoping the FDA takes some of the best comments to heart and improves a guidance that’s pretty close to the mark.

To learn more about a COTS solution for eMDR, click here.

Well, they finally did it.

After more delays and internal intrigue than your typical Hollywood Blockbuster, the FDA today unveiled their proposed guidance for ultimately mandating electronic submission of mandatory adverse event reports.

It’s going to save time (paper submissions take up to two weeks to process at FDA HQ) and money for both industry and the agency.

But will device firms be ready?

A telling stat that came out of today’s press teleconference announcing the draft guidance: While about 80% of the nearly 500,000 submissions CDER gets already come in electronically, on the CDRH device side it’s only about 15%.

“We have some work to do” on the device side, David Buckles, Ph.D., director of the Division of Postmarket Surveillance at the FDA’s Center for Devices and Radiological Health (CDRH), observed mildly at today’s press conference.

Why are pharma firms so far ahead of device firms here? It’s odd because in many ways device firms are viewed as more tech savvy and more of the early adopter type. But the fact that pharma companies are generally much bigger, with much deeper pockets, probably explains some of why they have such a big electronic jump on their device brethren.

Device companies have also complained that the FDA hadn’t made its eMDR expectations clear. But that excuse won’t really hold now that the agency has issued a pretty straightforward guidance.

Industry has 90 days to comment on the draft guidance. After that, the agency will take a few months maximum to digest and perhaps take advice from those comments. Then they’ll issue a final rule that will mandate esubmissions for mandatory reporting (such as adverse events) a year from then.

So, mark your calendar for sometime around February 2011 for a mandate from the agency.

Will device firms be ready? There’s no excuse not to get with the program now.

Download the PDF version of the draft guidance here.

More information about AssurX’s eMDR solution here.

The FDA is spending billions of dollars on IT modernization and standardization, so could this finally be the year they mandate eMDR?

The pace of eMDR adoption is also starting to pick up steam. Medical device manufacturers are typically considered early technology adopters but during 2006-2007 (see chart below), eMDR submissions stayed relatively unchanged year over year. However, starting in 2008 electronic submissions more than doubled, and will most likely at least triple this year. At the end of 2008, 11% of MDRs came via eMDR.

So is it time to start thinking about transitioning to eMDR? Most likely say experts from the FDA. According to Indira Konduri, “Get an early start now. We’re here to help and give personalized attention. Assistance from the FDA will be easier now — before it’s mandatory — and you’ll be ready to go when when eMDR is mandated.”

About the Webinar:

• Date: Wednesday, June 24, 2009
• Time: 10:00 am – 11:00 am Pacific
• To request recorded viewing of this event: http://www.assurx.com/eMDRJune09Webinar.html

AGENDA:

• Understanding Electronic Medical Device Reporting (eMDR)
• What the FDA is saying about eMDR and the options available to you today
• Making the switch from manual to fully automated electronic reporting
• The FDA’s ESG and how it works for both low and high volume submitters
• The FDA’s $2.5 billion commitment to IT modernization (and standardization)
• The FDA’s push for eMDR with the implementation of their new unified electronic system — FAERS
• A closer look at MedWatch Plus Portal
• The benefits of true eMDR and developing an effective strategy

TRUE eMDR IN ACTION LIVE DEMONSTRATION

Q&A SESSION

• Get your eMDR questions addressed by the experts in a Q&A forum

WHO SHOULD ATTEND:

• Regulatory Affairs and Compliance
• Quality Management
• Product Surveillance
• Information Technology

To request recorded viewing of this event: http://www.assurx.com/eMDRJune09Webinar.html

All attendees will also receive the newly updated 3rd Edition of the eMDR eBook “Leveraging the Benefits of eMDR: A Guide to Improved Operations with Electronic Medical Device Reporting”.

Click here to learn more about AssurX’s eMDR solution.

Too many medical device companies have the view that electronic medical device reporting (eMDR) won’t be mandated by the FDA anytime soon. That’s a pretty unrealistic view to take these days considering the amount of effort and money that’s being spent at the FDA to modernize their IT facility.  Look at the facts: The FDA’s systems are over 10 years old, and each center within the FDA maintains their own data center that can’t perform cross-departmental queries or has any real analytical tools – a key issue these days for combination products – recently exemplified with deaths related to Heparin coated devices.

Back in September 2008, the FDA announced it planned to spend $2.5 billion to upgrade its technology to better track the safety of drugs, devices and food. The funds will be rewarded to 10 contractors as the agency prepares to transfer their data tracking operations to two new systems.

One of those systems is the FAERS (FDA Adverse Event Reporting System). The FDA says this electronic system will be used for receiving, processing, evaluating and analyzing adverse event reports and other safety information for all FDA-regulated products. The new system, MedWatch Plus, will provide a single point of entry for all FDA regulated products and will combine all the various reporting processes and systems into a single repository. The FDA’s goal is to get away from a center-centric system, and combine it all into a unified adverse event environment.  FAERS will have advanced analytical tools and data mining capability to enable the FDA to standardize the reporting process, analyze thousands of safety reports, and efficiently identify and respond to safety issues.

For medical device companies, the FDA’s plan is to replace the current CDRH’s low volume CeSub (eSubmitter JAVA Applet based program) and implement the Web-based MedWatch Plus Portal. This system will be based on the HL7 ICSR messages that are currently in use by higher volume manufacturers for direct eMDR submissions using the FDA’s AS2 Gateway.

The MedWatch Plus Portal, dubbed the “Rational Questionnaire”, is a joint effort between the FDA and the NIH, and will be a Web-based system for use by consumers, health professionals, investigators, sponsors and other parties for electronic submission of AE reports. This is specifically designed for small device companies with low volume submissions.

The FDA plans to roll out the new FAERS system in phases, with CDRH slated for early 2010. That suggests that the guidance documents for eMDR are due out in the first half of this year, and will most likely require manufacturers to implement eMDR within a year or two.

Think this isn’t important to the FDA? Listen to them talk about it:

“For the first time, we will be able to collect and track safety information from virtually anyone who touches a particular FDA product throughout its life cycle—from manufacturing through initial marketing to its wide-spread use,” explained Dr. Rachel Behrman, FDA Associate Commissioner for Clinical Programs/ Director, Office of Critical Path Programs, the office supporting the effort.  “This will be a key component in an improved, nationwide surveillance system that will strengthen our ability to protect the Nation’s public health.”

For more information about eMDR and the future of the FDA including FAERS, request the 3rd edition of the eMDR eBook here.

The FDA is anxious for eMDR to be formally launched with a full-blown regulation. It’s been delayed, (mostly for internal reasons having more to do with a change in Administration than the actual contents of the reg, we hear) but it’s ultimately a matter of “when, not if,” an eMDR guidance will arrive.

Savvy medical device and drug manufacturers are getting ahead of the curve and embracing eMDR. Others are waiting to be ordered to do it.

Don’t wait too long. You risk losing a competitive advantage, for starters. Did you realize that 11% of MDRs came via eMDR in CY 2008? Or that thirty manufacturers are currently submitting electronically via eMDR?

Yep, it’s the companies that view this as a way to improve efficiency, speed approvals, and improve overall product quality that will ultimately thrive in the marketplace, experts stress.

The FDA just did a nice job updating its user guide to its Electronic Submissions Gateway (ESG). It’s available here at http://www.fda.gov/esg/userguide/WebHelp/default.htm

• Submission prep guidelines can be found here http://www.fda.gov/esg/userguide/WebHelp/default.htm
• Finally, the FDA’s home page for all things ESG can be found here http://www.fda.gov/esg/
• Assurx also has an updated eBook on eMDR that can be found here http://www.assurx.com/emdrebook.html
• And the FDA’s own eMDR page is here: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/ReportingAdverseEvents/ucm127932.htm