May 4, 2015

FDA’s CDER Unveils Ambitious 2015 Wish List

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

The holidays came a little early for the folks at the Center for Drug Evaluation and Research (CDER). They just released their sometimes optimistic, but always enlightening guidance wish list and overall priorities for 2015. Let’s take a look.

CDER Director Janet Woodcock recently said these are her agencies “front burner” priorities:

  • Implementing and clarifying statutory provisions on drug compounding.
  • Meeting Generic Drug User Fee Amendments (GDUFA) review goals that went into effect Oct. 1 last year.
  • Continue the build out of Office of Generic Drugs “super office.”
  • Build out the Office of Pharmaceutical Quality.
  • Implement and continue to develop Program Alignment Group agreements with the Office of Regulatory Affairs.

She singled out the implementation of a new process, data and document management IT system as a “big deal” goal this year

But there’s plenty more on FDA’s big front burner:

  • Respond as needed and participate in “21st Century Cures” legislative activities.
  • Rapidly re-evaluate regulation of drug advertising and promotion.
  • Execute immediate actions required by the Sunscreen Innovation Act and implement a longer-term plan.
  • Respond to Ebola outbreak.
  • Issue final guidances on abuse-deterrent opioid formulations.

She’s also hoping to fill more than 600 staff vacancies and recruit for a slew of executive positions.

prescription drugsWoodcock’s ambitious goals include five more bulleted pages of additional “important” priorities ranging from implementing a biosimiliars program, working on the Drug Label Improvement Initiative and developing a strategic plan for managing a growing pile of drug imports.

In the agency’s spare time, the plan is to issue nearly fifty guidances in advertising, biopharmaceuticals, biosimiliars, clinical medical/pharmacology/statistical/drug safety, electronic submissions, generics, and labeling, among others. Each of these guidances are already under development, CDER said earlier this month.

It’s certainly important to have goals, and a person’s reach should exceed their grasp, etc, but there’s also the problem of over-promising and under-delivering.

FDA’s got a big front burner but maybe not enough cooks, or oven space, to get it all done in 2015. We’ll keep an eye on it and report back throughout the year. Bon appetit.

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Are Energy and Utility Companies Ready for Risk Based Compliance?

Vice President, Energy & Utilities Compliance, AssurX Inc.

Vice President, Energy & Utilities Compliance, AssurX Inc.

Part 1: How the NERC Registered Entities are Preparing

As we enter into the New Year, many NERC Registered Entities are focused on their game plan to prepare and implement the “ERO Enterprise Risk-Based Compliance Monitoring and Enforcement Program.” This new program is different because it places an emphasis on the risk to the bulk power system (BPS) versus the existing oversight where the Regional Entities treat all Registered Entities equal no matter their size or risk to bulk power system.

Since the end of 2012, the ERO Enterprise and the Registered Entities have launched a multi-year effort called the Reliability Assurance Initiative (RAI). There have been multiple initiatives underway with the eight Regional Entities and some Registered Entities that have volunteered for RAI pilot programs. Lessons learned from these RAI pilot programs have been documented on the ERO websites. NERC and the regions continue to conduct outreach efforts throughout North America.

Many Registered Entities are having internal discussions on how to implement this new ERO Enterprise program. Some companies are looking internally to their compliance and risk-management departments to make recommendations for implementation. Other entities are reaching out to third party consultants to assist with their approach and implementation. The program is still voluntary and the ERO Enterprise is focused on the review of the potential risk posed by individual Registered Entities that would have the greatest impact on the reliability of the BPS.

The ERO Enterprise staff, Board of Trustees (BOT), Registered Entities, and the Reliability Issues Steering Committee (RISC) have been working to identify these key risk areas. These risks are identified and prioritized in the “ERO Enterprise Strategic Plan.”

The ERO Enterprise is using the “Risk Based Compliance Oversight Framework” to identify, prioritize and address these risks to the BPS.

Source: NERC

Source: NERC

AssurX, an industry leading GRC solution provider, is working closely with our energy and utility customers to address the implementation of the “ERO Enterprise Risk-Based Compliance Monitoring and Enforcement Program.” In a series of blog posts, we will be addressing Risk-Management and how having the proper Objectives, Sub-Objectives, Controls, Testing and Mitigation tools in place to successfully implement this new ERO initiative. We have customers that have taken part in the RAI pilot programs. They are working with us to enhance their risk-management and compliance programs and we want to share these lessons learned and best practices with other industry stakeholders.

On the NERC website, there are some excellent resource documents that are posted. We recommend the following documents for a good understanding of this ERO Enterprise program:

The next area of discussion – addressing the results of the ERO Inherent Risk Assessment (IRA). We will discuss the development of internal controls with each risk including preventive, detective, and/or corrective internal controls.

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FDA FastStats: A Look Back at all FDA 483 Inspectional Observations for Fiscal Year 2014

In our last FDA FastStats series of the year, we look back at all FDA 483 Inspectional Observations for Fiscal Year 2014. 483s increased in foods from the prior fiscal year to 2476, an increase of 3.8%. However, medical devices and drugs were down -11.6% and -6.5%, respectively, from FY 2013. Interestingly, medical device 483s bucked their recent upward trend with the lowest number of observations since FY 2009.

FastStatsALL483s2014

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FDA Update on UDI Implementation for Registered Medical Device Establishments

In case you missed it, the FDA issued this update on UDI yesterday:

Having passed the first Unique Device Identification System compliance date of September 24, 2014 (for Class III devices and devices licensed under the Public Health Service Act), the FDA’s Center for Devices and Radiological Health (CDRH) would like to take this opportunity to summarize recent and upcoming UDI activities and deadlines. The next two compliance dates for UDI requirements are:

September 24, 2015 for non-class III implantable, life-supporting, and life-sustaining (I/LS/LS) devices

September 24, 2016 for class II devices

Global Unique Device Identification Database (GUDID) Data Submission:

FDAlogoIn January 2015, we will begin accepting GUDID account requests from labelers of I/LS/LS devices. Later in 2015, we plan to accept GUDID account requests from labelers of class II devices. We strongly encourage all device labelers to take steps to ensure their readiness to meet UDI requirements well before actual data submission to GUDID. This will provide labelers with ample opportunity to assess their ability to meet requirements, including data submission to the GUDID, by their deadline and to work with us if they have any difficulties coming into compliance. Suggested steps are included on the UDI website.

Also in January, we will host a webinar to help Class II and I/LS/LS device labelers prepare to comply with the UDI rule. Notification of webinar specifics will be sent directly to these device labelers in early January. The webinar will include overviews of UDI requirements and how to get started with the GUDID.

UDI Policy:

We continue to work with industry on UDI implementation issues that surfaced in 2014, including GUDID data submission for contact lenses/IOLs and development of approaches to ensure the UDI is available at the point of use for non-sterile implants. We recognize there are several other policy issues that are of significant interest to industry; we hope to address a number them in 2015, such as UDI direct marking requirements, convenience kits, posting of decisions on UDI exceptions and alternatives, and issuance of additional Frequently Asked Questions (FAQs).

The use of National Health Related Items Code (NHRIC) and National Drug Code (NDC) numbers for devices is being phased out over a time period that corresponds with thecompliance dates for UDI requirements. Device labelers that want to retain the use of FDA-issued NHRIC or NDC labeler codes under a system for the issuance of UDIs were required to request such continued use by September 24, 2014. If you intend to retain the use of a previously issued FDA labeler code within your UDI system but have not made such a request, we urge you to do so as soon as possible.

UDI Adoption and Use:

We continue to collaborate with stakeholders, such as the Pew Charitable Trusts, the Office of the National Coordinator for Health IT (ONC), and the Brookings Institution to promote and facilitate UDI adoption in health care settings.

We are working with the National Library of Medicine (NLM) to give the public search and download access to published records in the GUDID in the spring of 2015. GUDID search will allow published GUDID data to be retrieved based on parameters of interest to the user. The GUDID download function will let users download all published GUDID data at once.

Finally, we’d like to reaffirm our plans to implement this important system over several years—and underscore the fact that we fully intend to be flexible during this time. Our main focus is getting the system implemented correctly and actively helping companies comply with system requirements. As with the implementation of many new systems, it can take time to understand and comply with new requirements—widespread, strict enforcement of associated deadlines and requirements is not necessarily the best way to achieve compliance at this time.

To date, industry has been very willing to work with CDRH, and we have experienced excellent efforts and strong feedback. We urge labelers that are having difficulty fulfilling UDI requirements to let us know through the FDA UDI Help Desk.

We will continue to work diligently to give the medical device industry, health care systems, clinicians and patients the assistance and information needed to implement and use UDI successfully. For additional information, please see www.fda.gov/udi or contact us at the FDA UDI Help Desk.

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Got Safe Beef? New Report Suggests the US Doesn’t

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

The next time you want a cheeseburger, you might consider hopping a plane and flying to Germany. Or France. Or New Zealand. Basically, anywhere but the United States of America.

Almost across the board, the US ranks at the bottom (“regressive”) for produce traceability programs as ranked by a new Institute of Food Technologists (IFT) report.

IFT checked out 21 countries and rated them “Progressive,” “Moderate,” or “Regressive” based on a handful of criteria.

While the landmark Food Safety Modernization Act of 2010 (FSMA) is expected to improve things here in America, “development of regulations are still in the early stages,” the study noted. Technically, the study is called “Comparison of Global Food Traceability Regulations and Requirements.” That’s quite a mouthful, pun intended. An earlier IFT powerpoint presentation also examined this important issue.

FSMA was signed into law by President Obama on January 4, 2011. FSMA was designed to give the Food and Drug Administration (FDA) new power to regulate the way foods are grown, harvested and processed. The law grants FDA a number of new tools, the most important of which is mandatory recall authority. But that’s all in the future. The IFT report tells us what’s going on right now.

Where to start when reading the report? The ranking of 21 countries (EU, China, Japan and a few elsewhere including Brazil and the land of the Kiwis) found that the US was only one of two major beef exporters without mandatory red-meat traceability systems. It also lagged behind most of the group with a weak consumer access program.

Generally, countries in the EU (France, UK, Germany, Ireland et al) led the group. That’s thanks, in part, to tough standards imposed in 2005 that include mandatory traceability programs for food, feed, food-producing animals and any other substance incorporated into food or feed.

livestockBlog

The US did achieve some distinctions — pretty much all bad. For example, it joined China as the only countries rated regressive when it comes to the breadth of products regulatory traceability regulations.

The US, China and Canada are also the only members of another not-so-attractive-club: Regressive electronic livestock traceability programs.

In its summary, the report diplomatically notes the obvious: The US “trails most other nations.”

Let’s wrap this up on something of a positive note.The US did make the top category for voluntary traceability programs. An optimist might say US meat exporters are significantly exceeding their nation’s relatively lax regulatory requirements. Pessimists might still urge you to think twice before buying that next cheeseburger, chicken sandwich, or tilapia in America — at least until the FSMA kicks in.

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FDA FastStats: A Look Back at 2013 Medical Device Warning Letters with Quality System Deficiencies

In our latest infographic analysis, today’s post highlights medical device warning letters with quality system deficiencies. Surprisingly, warning letters were actually down 12.2% from 2012. However, they are almost double the number (77) issued in 2009. Are we looking at a downward trend? The jury’s still out. The highest number of warning letters issued in the past 10 years was in 2012, with a total of 164. The lowest was 2007, with only 74 warning letters issued.

FDA FastStats 2013 - Warning Letters

 

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FDA FastStats: A Look Back at 2013 Medical Device 483 Observations

As we approach the end of 2014, we will take a look back at FDA’s stats on various topics sourced from their Case for Quality initiative. The FDA believes that the following type of information will:

  • Help industry improve medical device quality by sharing common observations
  • Identify possible areas of emerging concern, and
  • Possibly help firms avoid warning letters

Our first in the series of infographics is 483 inspectional observations.

FDAFastStats2013cr

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FDA’s Local Offices Flex Regulatory Muscle

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

In our latest round-up, it was the District Offices turn to chime in on medical device company alleged shortcomings.

As expected, FDA is shifting more and more of its regulatory focus toward Medical Device Reporting (MDR). In an October 1 letter, the agency’s Baltimore District Office hit Baltimore-based Electronic Development Labs for not having an MDR procedure. Bad idea.

The company may not have recovered very well, either. “The adequacy of your firm’s response dated November 20, 2013, cannot be determined at this time,” FDA’s warning letter said. “Your firm’s response indicates that the development of an MDR procedure was added to a list of action items. In order to determine adequacy, FDA must receive a copy of the MDR procedure for review.” Electronic Develop makes the NervoScope.

The agency also gently encouraged the company to look into eMDR.

As we’ve noted before, FDA eMDR Final Rule requiring manufactures and importers to submit electronic Medical Device Reports (eMDRs) to FDA was published on February 13, 2014. The requirements of this final rule will take effect on August 14, 2015. If a firm is not currently submitting reports electronically, FDA politely encourages it look into it on FDA’s web page devoted to eMDR.

The FDA demonstrated its ongoing interest in CAPA in an October 7 letter from its Los Angeles Office to Alpha Medical, a maker of angiographic balloon catheters.

warning640After Alpha tried to respond to a September inspection, FDA made it clear the reply needed some work. Example: “CAPA 104 was opened on January 10, 2013, concerning non-conformities regarding balloon extension air leaks. The CAPA report references multiple root causes for these leaks; however not all of these potential causes were analyzed and investigated.”

The agency went on, “Your records reference that personnel were retrained, but the corrective actions for which they were retrained were not documented. Additionally, this CAPA was closed on February 22, 2013 without documentation that an effectiveness check was performed.

In an October 10 letter from the Cincinnati District Office, local regulators challenged West Lake Enterprises, maker of medical gas pressure regulators and suction regulators, with CAPA and other violations, including installation that’s not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation. The company responded, and FDA came back with additional questions.

The Denver District Office joined in with an October 28 letter to Xanacare Technologies, maker of SimulCare II, a therapeutic lamp/nerve stimulator/massager. The agency hit them for several issues, including problematic design control, device history records (DHR) and complaint handling. As of late October, the agency said it had not received a response from Xanacare.

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Are You Ready for 21st Century eMDR Submissions?

Jeff Mazik

Jeff Mazik, Vice President, Life Science Solutions, AssurX

If you have been procrastinating on setting up electronic submissions for your adverse event reports to the FDA, you might want to reconsider that decision. Earlier this year, the FDA published its final rule on MedWatch/eMDR reporting. Although not much has changed in this final rule in regard either to required content, the submission process, or submission timelines, the FDA has taken a large step closer to mandating 21st century technology. The final rule states that all required adverse events are to be submitted electronically by August 14, 2015.   The clock continues to tick…

Not sure if you’re handling this new reality properly? Well, here’s a quick way to find out.

Are you (or your management) making any of these statements:

“The FDA always delays, we will just wait and see.”

FDA has shown no indications of changing or extending this electronic submission requirement timeline. Their hardline stance is mostly due to the fact that electronic submissions of the MedWatch form via electronic means (through their ESG) has been available for many years on a voluntary basis. Numerous manufacturers have taken advantage of this technology over the last number of years to streamline adverse event reporting. Soon, the electronic submission process for these reports becomes mandatory.

We don’t submit a lot of complaints, we will just wait until we have something to report.”

Maybe your company does not have many adverse events to report…maybe only once in a blue moon (great for you!). However, if you wait until a complaint occurs (after August 14, 2015), and the complaint results in a reportable event that requires submission, you are caught in a very dangerous game of Russian roulette. You see, an electronic account is required to be set up prior to an eMDR submission. FDA has previously stated that the setup of an account takes between two-to-six weeks (not counting the form completion process and ensuring all was filled out correctly). Now, depending on the adverse event, you will have between five to 30 days to officially submit it to the FDA, electronically. With a two to six-week wait on an account, you will be caught in a waiting game that in all likelihood will make you non-compliant. That’s not a good place to be.

Don’t get caught in this game where you are most likely going to lose. There are options available to do this submission electronically in a secure, managed, workflow driven environment.

“Ok, Im convinced, what options do I have for submitting electronically?”

If you already submit your adverse events to the FDA electronically, there is nothing you need to change. However, if you do not and are still submitting via paper/PDF, now is the time to start investigating your options. Although the FDA provides the eSubmitter tool to help you submit the reports electronically, it does not integrate with your electronic quality management system, provide electronic signature approvals, a workflow process, KPI measurements, or the like. In many cases users will be required to re-key or copy/paste data from their original source. This error prone, non-integrated solution leaves much to be desired, but it does serve as a quick and easy way to submit the completed report.

eMDR

AssurX eMDR Process

A better, more integrated business model is available, however. AssurX, a leading EQMS provider, has for many years offered a low cost standalone eMDR electronic submission solution. Furthermore, it can optionally be fully integrated into a complaints management workflow solution for your business, providing electronic reviews and approvals, tracking tasks, generating email notification and escalations, as well as identifying trends and tracking key performance indicators for your business. Either of these AssurX solutions can be implemented on premise, or in a privately hosted “cloud” solution that allows you to implement more quickly and with lower start-up costs.

It’s time. Get started now.

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Report: Medical Device Approval Still Lags, but FDA is Trying

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

After years of decline, the speed of FDA device approvals has finally begun to hit the gas pedal a bit, says an interesting new report from the California Healthcare Institute (CHI) and Boston Consulting Group (BCG).

In hindsight, it appears FDA hit a bottom in 2010 when approval times averaged a staggering four years longer in the US than Europe. Those delays, the report argues, kept proven, life-saving technologies from American patients unless they traveled abroad. Worse, there’s no evidence the FDA’s snail-like approach to approvals made products used in the US any more effective or safe.

Congress and the FDA came together in 2012 to try and find ways to implement, and fund, new policies designed to improve regulatory clarity, consistency and predictability. Industry agreed to pay significantly higher users fees to help make it happen. The new approach was collected in the Medical Device User Fee Amendments of 2012 (MDUFA III).

The verdict? “Real improvements are evident, yet there are still areas of concern.”

It’s worth noting that CHI and BCG applaud the Center for Devices and Radiological Health (CDRH) for working hard to “get processes, internally and with industry, back on track.”

FDAlogoThere’s some good evidence out there to support industry optimism. Report data suggests that, after a 2010 nadir, the PMA classes of 2011 and 2012 will show the best overall review-time performance of the device user fee era. Early returns for 2013 show even further improvement, though the study cautions that there are simply too many products awaiting a decision to make rock-solid claims just yet.

If PMA is part of the good news, the weather report in 510(k) land is far less sunny. Review times in 2012 were 60 percent longer than 2000, say CHI and BCG. But unlike the relative success with PMAs, today’s 510(k) review times “continue to remain far higher, and processes are still viewed as less predictable, than during the pre-device user fee era,” according to the report, Taking the Pulse of Medical Device Regulation & Innovation.

Another disheartening finding: The lag between FDA approval and faster action in Europe hasn’t changed much so far. Europe’s regulatory environment continues to lure US medical technology business away. “Only time will tell if recent improvements at the FDA ultimately have any impact on this gap,” the report summarizes.

Back in my elementary school days, most teachers took great pains to encourage a student who was genuinely trying — even if the results were not always so great. Maybe we should give the FDA a hearty pat on the back instead of a kick in the rear. It just might work.

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