October 25, 2014

Charles Darwin, Social Media & The FDA’s New Guidance

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

If someone out in there in the wild wonderful world of the Web takes a potshot at your drug or device, the first thing to do is take a deep breath and think. Any crisis communications executive worth his or her salt will tell you it’s often best to let the attacker eat silence rather than draw more attention to their criticism or cheap shot.

But if the criticism is relentless, or damaging and unfair, if it looks to be gaining traction, then a measured response can be part of the solution.

The FDA just released a guidance it says “responds to (among other things) stakeholder requests for specific guidance regarding a firm’s voluntary correction of misinformation when that misinformation is created or disseminated by an independent third party.” In other words, how to fight back fairly.

But the short guidance is vague on specifics, though it does give us a “helpful” reminder that the Internet makes it much easier for third-parties to easily disseminate information about your products and your company. The agency calls it User-Generated Content (UCG). I don’t mean to sound like an elitist snob, but this sounds kind of obvious to me.

“I wouldn’t call this guidance useless…well, yes I would,” a device industry consultant told us. He asked to remain anonymous on the off chance anyone at the FDA ever reads this blog.

Is the guidance helpful? You be the judge. Here’s how the FDA advises a drug or device company to address negative and or inaccurate claims online:

  • Be relevant and responsive to the misinformation;
  • Be limited and tailored to the misinformation;
  • Be non-promotional in nature, tone, and presentation;
  • Be accurate;
  • Be consistent with the FDA-required labeling for the product;
  • Be supported by sufficient evidence, including substantial evidence, when appropriate, for prescription drugs;
  • Either be posted in conjunction with the misinformation in the same area or forum (if posted directly to the forum by the firm), or should reference the misinformation and be intended to be posted in conjunction with the misinformation (if provided to the forum operator or author); and
  • Disclose that the person providing the corrective information is affiliated with the firm that manufactures, packs, or distributes the product.

I suppose writing all of this down somewhere doesn’t hurt anything except the trees killed when it is printed out. Still, it feels a bit like FDA is talking down to future winners of the Darwin Awards. That’s the “prize” named in honor of Charles Darwin, the father of evolution. The Darwin Awards commemorate those who “improve our gene pool by removing themselves from it.”

Here’s a good example of a Darwin Award: In 2000, a motorcycle taxi driver challenged his neighbor to stand beneath a hornets’ nest, while two men pelted it with stones. The 53-year old man should have known better, but he had a local reputation as a strong man to uphold. He stood beneath the nest and the pelting commenced. The man endured the pain of countless stinging hornets before expiring from the toxic injections.

To be fair, if you need an FDA guidance to tell you to “be accurate,” I’d also say you may need a reminder to stay away from hornets or men holding stones. Otherwise, there’s no harm bookmarking this new guidance in your computer.

But don’t print it out, please. It’s not fair to the trees.

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FDA Acts to Harmonize Global Adverse Event Reporting

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

It’s a small world after all. One of the by-products of globalization is the speed and spread of everything from t-shirts to medical devices.

But everything has its plusses and minuses. When it comes to globalization, a plus for American’s is something like high-quality inexpensive clothes from my haberdasher of choice, J. Crew. On the minus side, we’ve got MERS hitting our shores.

Of course, t-shirts are one thing and safe medical devices and drugs are quite another.

As the FDA has learned, health regulations and standards in one nation do not often translate, figuratively and literally, to another nation.

Zeroing in on one of the most pressing requirements, FDA is working with the International Conference on Harmonization (ICH) to harmonize global adverse event reporting forms and requirements. It won’t be easy, but the two organizations appear to be off to a good start.

A recent notice in the Federal Register outlines a step forward covering three parts of the globe: the United States, Japan and the European Union. It does not address other parts of the world.

The core of the new effort is the Periodic Benefit-Risk Evaluation Report (PBRER) draft guidance first issued in 2012, building on a guidance issued in 1997 and amended in 2004. PBRER is designed to “promote a consistent approach to periodic postmarket safety reporting among the ICH regions and improve efficiency by reducing the number of reports generated for submission to regulatory bodies.

FDAlogoFDA advises that companies operating in more than one country or region may find it easier to prepare a single PBRER rather than preparing multiple types of reports for multiple regulators.

FDA also outlines some situations where medical device companies must be granted a waiver, and other situations where they can apply for a waiver. Existing regulations permit applicants to request waivers of any post marketing safety reporting requirement, and the information collections associated with those waiver requests are “generally are approved” under existing regulations, FDA says.

Comments are due by June 9th.

 

 

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Medical Device Warning Letter Round-Up: FDA Won’t Take No For an Answer

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

This latest round of warning letters is all about pushback.

The FDA is not happy with the responses it received from Acme Monaco Corp., a New Britain, Connecticut-based manufacturer of medical guardwires for cardiovascular and urologic use.

In an April 28 letter, the agency reminds the company that an earlier FDA inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Parts 820.

Mar Cor Purification in Minnesota was hit with an April 17 letter that found fault with, among other things, its CAPA, complaint handling, and document control. In addition, the FDA said Mar Cor’s March responses were inadequate. Mar Cor manufactures water purificaiton systems used to diagnose diseases.

FDAlogoHeading over to Wisconsin, a March FDA letter hit Cytophill Inc, a manufacturer or synthetic bone graft material, bone void fillers, and an intranasal splint, for a number of shortcomings.

In addition to hitting the firm for below mark CAPA, process and storage controls, FDA warned it about failure to:

  • Control environmental conditions
  • Validate a process whose results cannot be verified by subsequent inspection and test
  • Establish procedures to handle changes to a specification.

As many former FDA inspectors have told us over the years, a bad response to a warning letter is a really bad idea. Most FDA inspectors will work with you if they believe you are acting in good faith to correct the problem. It’s not unlike the IRS. If you call them and work out a lenient, reasonable payment plan, everything’s fine. Unless you miss a payment or two without giving them a heads-up. That’s when the trouble usually begins.

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Medical Device Industry Endures Tough 2013; 2014 Prospects Not Much Better

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

It’s March, but you could forgive medical device company leaders if they’re still smarting a bit from a generally tough 2013. Several new studies indicate a low level of mergers and financing last year, which could slow product innovation down the line, a drop in 2013 product approvals, and a mixed report on how that medical device excise tax thing is impacting hiring and other initiatives.

Let’s start with taxes. Studies from the Emergo Group, AdvaMed, and comments from the Medical Imaging & Technology Alliance (MITA) paint slightly different pictures, though none says the tax is good for the industry — the reaction has ranged from sort of bad to really bad.

Emergo’s survey, which has been criticized by MITA but endorsed by AdvaMed, said effects weren’t good, but weren’t as bad as predicted. In 2013, 75% of respondents said the tax would result in major (read: bad) changes in their business. But fewer than half said it had actually gone down that way in a similar Emergo study this year.

AdvaMed, which has applauded some recent efforts to repeal the device tax, saw a bleaker picture. Nearly 40 member companies reported that the tax forced 14,000 layoffs, and big reductions in R&D and start-up company investment.

That last bit is troubling — and may be with us for awhile.

downward trend

A recent survey by EP Vantage (EP) found 2013 to be one of the worst on record in terms of mergers and financing activity which “could contribute to a lack of innovative devices in future.”

The recent past doesn’t look so hot, either, according to EP. Last year, the FDA approved just 23 innovative devices, that’s down 44% from 2012.

“The increasingly stringent FDA approval process means that devices tend to gain European approval around three to five years before they reach the US market.” But wait, the bad news gets worse. Proposed changes in the EU approval system might throw a spanner in the works there, too, EP warns.

Still, there’s a potential silver lining: If EU approval gets significantly tougher, it could put pressure on the FDA to continue efforts to speed things back in the 50 states. “To its credit, FDA is aware of this [potential EU approval slowdown] and is weighing options to combat it [including] the new de novo pathway, a swifter review process for low-risk devices intended for unmet needs.”

FDA weighing some changes is good news for the device industry. Until then, its the medical device industry struggling under the increasingly heavy burden.

 

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The Six C’s of Complaints Management Best Practices for Life Sciences

Jeff Mazik, Vice President, Life Science Solutions, AssurX

Jeff Mazik, Vice President, Life Science Solutions, AssurX

Companies in the Pharmaceutical, Medical Device, and Biotech industries must meet many regulatory requirements for a number of regulatory agencies. Chief among these are requirements from the FDA, as well as from ISO, plus they must meet expectations from a number of other regulatory agencies, depending on the particular market. Implementing best practice solutions for a company’s quality processes is essential to insure compliance and quality for the organization.

When it comes to Complaints Management, a best practice approach can be summed up into the Six C’s of Complaints Management. These six terms help identify the areas that need to be addressed when initiating a best practice complaints management system.

The Six C’s are:

Collection: Collect as much information at intake of the complaint as possible. This is a major customer “touch point” in the complaints resolution process, so don’t waste it. Furthermore, the collection of incoming complaints must be reviewed to determine if the communication is truly a complaint. Depending on the determination of that review, handle the situation accordingly.

complaintConsistency: Incoming complaints must be recorded with consistency in the information collected. To help facilitate this, questions to ask the customer must be designed to be consistent across similar events, allowing for accurate trending of product problems. Also, steps taken downstream in resolving the complaints process should be guided by providing consistent information to all people in the complaint resolution process.

Communication: Information collected during intake and throughout the process must be easily available to everyone in the complaint resolution process. Furthermore, those people in the complaints resolution process that are assigned tasks must be provided communication and reminders to insure their tasks are being completed on-time and never “fall through the cracks”. From a customer satisfaction perspective, the customer reporting the event must be informed of the status of the complaint using form letters or via online queries using a web portal.

Compliance: The electronic system must meet all applicable regulatory requirements. Furthermore, a consistent approach must be used to determine how soon complaints should be reported to the applicable regulatory agency.

Control: As with any validated system, changes to the process need to be controlled and managed under change control procedures. However, controlling one’s business in terms of allocating available resources, trending historical complaint attributes, and proper management of returned products is also essential for the business to succeed.

Configurability: The solution you use should be easily configured, maintained, and updated, breaking you from a strong reliance on costly programmers, consultants, and specialized IT resources to make a change or to add a step to the process.

If you are interested in getting more detailed information on the Six C’s of Complaints Management Best Practices please request to view our recent 60-minute “Life Science Best Practices for Handling Complaints” Webinar here.

 

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CDRH 2014 Strategic Priorities Promise Improved IDE, PMA Regulatory Climate

Tamar June

Tamar June, VP, Strategic Marketing, AssurX, Inc.

The Center for Devices and Radiological Health (CDRH) will focus on encouraging medical device innovation and speeding clinical trials in the coming years, according to its 2014-2015 Strategic Priorities report released Feb. 5.

To help encourage that innovation, CDRH says it’s going to work to improve the consistency of the Investigational Device Exemption (IDE) process, especially in the areas of consistency and speed with which it handles applications. CDRH also pledges to find ways to encourage more early IDE studies — especially for those with medical devices aimed at the U.S. patient marketplace.

The report also says CDRH will try to find a better balance between premarket and postmarket data requirements.

CDRH sets measurable metric goals for improving IDE cycles:

  • By September 30, 2014, reduce the number of IDEs requiring more than two cycles to an appropriate full approval decision by 25 percent compared to FY 2013 performance.
  • By September 30, 2014, for disapproved IDEs, offer all sponsors a teleconference or in-person meeting to occur within 10 business days of the IDE decision.
  • By June 30, 2015, reduce the number of IDEs requiring more than two cycles to an appropriate full approval decision by 50 percent compared to FY 2013 performance.

Time to IDE Approval:

  • By September 30, 2014, reduce the overall median time to appropriate full IDE approval by 25 percent compared to FY 2013 performance.
  • By June 30, 2015, reduce the overall median time to full appropriate IDE approval to 30 days.
  • In FY 2013 (as of 12/11/2013), 45% of IDEs received a full approval decision within 2 cycles and median time to full IDE approval was 174 days.

2014 ClockBy June 30, 2015, the report says CDRH intends to increase the number of early feasibility/first-in-human IDE studies submitted to each premarket division compared to FY 2013 performance. CDRH promises several action steps here, including:

  • Establish in the Office of Device Evaluation a premarket clinical trials program responsible for the oversight and performance of the IDE Program and the development and implementation of policies that contribute to the timely initiation and successful execution of medical device clinical trials.
  • Formalize the incorporation of our benefit-risk framework, including patient-specific factors such as tolerance for risk and perspective on benefit, into the IDE process.
  • Establish a process to efficiently and objectively resolve application-specific IDE issues to reduce the number of multi-cycle IDEs.
  • Develop a clinical trials education and training program for CDRH review staff, managers, and industry.
  • Develop real-time metrics to track CDRH and industry IDE and clinical trial performance.

Turning to premarket and postmarket data requirements, the CDRH call to arms lays down more goals:

  • By December 31, 2014, review 50 percent of device types subject to a PMA that have been on the market to determine whether or not to shift some premarket data requirements to the postmarket setting or to pursue down classification, and communicate those decisions to the public.
  • By June 30, 2015, review 75 percent of device types subject to a PMA that have been on the market to determine whether or not to shift some premarket data requirements to the postmarket setting or to pursue down classification, and communicate those decisions to the public.
  • By December 31, 2015, review 100 percent of device types subject to a PMA that have been on the market to determine whether or not to shift some premarket data requirements to the postmarket setting or to pursue down classification, and communicate those decisions to the public.

CDRH plans several specific actions to help attain those targets, including:

  • Develop and seek public comment on a framework for when it is appropriate to shift premarket data collection to the postmarket setting.
  • Conduct a retrospective review of all PMA device types to determine whether or not to shift some premarket data requirements to the postmarket setting or to down classify device types in light of our current understanding of the technology.
  • Implement a mechanism to prospectively assure the appropriate balance of premarket and postmarket data requirements for new devices subject to a PMA.
  • Using existing authorities, develop and seek public comment on a new pathway to market for devices subject to a PMA that address an unmet public health need by shifting appropriate premarket data needs to the postmarket setting and incorporating features of the Innovation Pathway pilots.

The medical device industry no doubt applauds the majority of these goals. Now it’s time for CDRH to roll up its sleeves and get them done.

 

 

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Medical Device Industry Identifies Some Problems with Agency’s UDI Initiative

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Let’s start with what most everyone agrees on: The Unique Device Identification (UDI) program is a swell idea.

It gets a little trickier after that.

In extensive comments, the Advanced Medical Technology Association (AdvaMed), Boston Scientific, and Merck, among more than a dozen others, generally voice support for the UDI concept, while finding lots and lots to say about where the FDA’s September Draft Guidance could use improvement.

Noting that implementing UDI will be a “costly proposition,” AdvaMed stresses that the length and complexity of the implementation plan demands a “living document” approach that will allow industry and the FDA to update and improve the guidance as both sides learn more during set-up. AdvaMed follows with 61 specific comments, with suggested changes.

Coviden, manufacturer of medical devices and medical supplies, echoes AdvaMed’s comments, and tosses another 22 into the mix, including a request that the guidance remain open for feedback and comment until the September 24, 2014 implementation deadline.

Merck, among other commenters, requested clarification and summarization regarding the scope of products for which data must be submitted to the Global Unique Identification Database (GUDID). Merck also asked FDA to add information regarding deadlines for submitting data to GUDID.

X-ray of hipBoston Scientific, noting that its medical devices already bear unique identification via HIBCC or GS1 standards, calls FDA out for what it labels “inconsistencies” with the FDA UDI Rule.

To pick one of their examples, and joining several other commenters in making this point, Boston Scientific claims the data elements column “Required?” is unclear because it fails to clarify if it is required to follow the rule based on regulatory requirements or validation requirements. “The meaning of ‘required’ should be clarified so that BOTH regulatory and system validation requirements are clearly identified in this guidance.”

FDA’s got its work cut out for it here, particularly with the recent departure of its UDI guru, Jay Crowley, for the greener fields of consultantdom.

We can offer some small consolation though: Crowley leads a webinar on UDI implementation from his new professional perch. Information is here:

 

Final UDI rule as published in Federal Register

FDA’s UDI page

Previous AssurX blog on UDI

The entire comment letter line-up is available here

 

 

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Interpreting the FDA View of Medical Device Design Controls

Dennis Payton, Vice President of Product Marketing and Development, Expandable Software, Inc.

Dennis Payton, Vice President of Product Marketing and Development, Expandable Software, Inc.

Some of the shortest descriptions in the FDA CFR 21 Part 820 Quality System regulation are found in Sec. 820.30 and Sec. 820.40 totaling about a page of written language around Design Controls and Document Controls. However short, these two sections can be the most complex aspects of Medical Device controls when actual complying with the regulation. Fortunately, the FDA does give a bit more background to help a new medical device company understand these two key elements (see Medical Device Quality Systems Manual, A Small Entity Compliance Guide) but again with the detailed complexities, even those few pages of guidance (covered in section 9 Document and Change Control) fall short of coverage needed to understand the impact a company’s Medical Device Quality System. The good news is that there are some very good tools that can help mitigate these complexities and streamline controls. The bad news is that it still takes a very strong detailed and sustained effort to insure these complex controls are in place for continued success and compliance with regulation.

With a wide variety of Medical Device suppliers there comes a wide variety of processes, procedures and controls that are developed specific to a business and to the Medical Device(s) being produced. It is important to understand how the FDA tries to normalize a specific business to the regulation when auditing that business for Design Control compliance. Having a bit of understanding of their view will help make for a much smoother comparison, analogy and a much cleaner and successful audit of a company’s design processes.

A simplistic model can be derived from the 820.30 regulation that the FDA may use to assure design coverage and compliance of a device design and/or manufacture to the regulation. The design and development model can be graphically depicted and loosely linked to the regulation as follows:

FDA Design and Development Planning Model

Diagraming out the design flow is helpful in seeing a more detailed picture of the flow and validation and verification of a product against its intended use model and specifically important to the FDA that each and every stage of the process is well reviewed and documented.

Again, like the FDA regulation on Design Controls, this is a very short summary of complex processes, document definitions, controls and general management & approvals that there have been volumes of books written. The objective should be to have a very good understanding of how the FDA or other regulatory entity views the medical device controls such that a business can demonstrate how their particular controls map into the regulatory model. A logical analogy of a business’ design and development model should be able to map to the regulatory normalized base line model(s), in doing so, will result in smoother audits with a higher degree of success and hopefully (something the regulatory folks don’t really care about but as a business we all do) a lower expense/time in managing through the audit process.

A fuller descriptive paper outlines some key points in the development of a Medtech-specific design control with a product development process and how to maximize the use of enterprise level business tools that accelerate process, streamline audits and make for a much smoother compliance. The brief outline here is a key element to a more streamlined and smoother compliance with regulation keeping in mind not just the business drivers but also the FDA’s “normalized view” of design controls.

Get the full detailed White Paper here

About the Author

Dennis Payton is Vice President of Product Marketing and Development with Expandable Software Inc. He has 24 years of engineering, product management and executive management experience. He holds a BS in electrical engineering from California Polytechnic State University, San Louis Obispo, and post studies at Stanford University, University of California, Santa Cruz, and UC Berkley Haas School of Business.

 

Copyright UBM Canon. Used by permission.

 

 

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FDA’s 2014 Promises Increased International Operations, Label Enforcement

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Given the fact that the FDA probably doesn’t know what it plans to do in 2014, predicting their actions is challenging, to put it mildly.

With that slightly weasel-like caveat, it’s worth noting three events in 2013 that will almost certainly impact 2014:

1) CDRH’s Office of Compliance Reorganization: With the addition of a Division of International Compliance Operations, watch for the FDA to shift focus and some budget funds to increased inspection and audits of foreign device manufacturers, and increased crackdowns on promotional claims (see below). Steve Silverman, Office of Compliance Director, is making the public relations rounds of late with events at a trade shows and the like. He’s stressing that the new “look” OC will better harmonize and broaden enforcement efforts. We’ll keep an eye on this and report back.

FDAlogo2) Device Off-Label Enforcement: If the old expression “the past is prologue” holds true, device makers would be well advised to take a good hard look at any public claims they, or a surrogate such as a doctor at a trade show, make about the wonderful things its gizmo can or will do for patients. Between May 1, 2012 and April 30, 2013, CDRH averaged two letters per month hitting device makers for making claims outside their 510(l) clearance and making claims requiring additional data they didn’t provide, among other issues. Early anecdotal evidence suggests this trend of more focus and more warning letters will continue to climb in 2014. Again, we’ll keep an eye out.

3) UDI Finally: FDA issued the long-awaited Unique Device Identification (UDI) Final Rule in September. Its driving force and 27 year FDA veteran Jay Crowley, has since left the agency for a consulting gig. It remains to been seen what impact, if any, his departure will have on an issue that’s vexed industry and the agency for many moons. I can’t think Crowley leaving is any kind of net plus in terms of helping to fine-tune the rule. Time will tell. Then we’ll tell you.

I didn’t even factor in the possibility of more budget shenanigans in Washington, D.C. I’m a naive romantic, and I’m not going to go there until I have to.

Happy new year!

 

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FDA Draft Medical Device Development Tools Guidance is Here to Help

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

A new FDA draft guidance just issued by the Center for Devices and Diagnostic Health (CDRH), outlining a voluntary process for qualification of medical device development tools (MDDT), is designed to facilitate the development and “timely evaluation of innovative” medical devices, the Center says.

An MDDT is a scientifically validated tool — such as a clinical outcome assessment or a test to detect or measure a biomarker — designed to aid device development and regulatory evaluation.

The guidance, issued November 14, 2013, describes the framework and process of voluntary CDRH qualification of MDDT.

It also includes a helpful definition of key concepts that provide something of a window into FDA’s viewpoint and regulatory expectations. Here are two important examples of how FDA views the world:

  • Qualification: A conclusion that within a specified context of use (FDA’s italics), CDRH expects that the results of an assessment that uses MDDT can be relied upon to support device development and regulatory-decision making.
  • Context of Use: Use defined in part by the device or product area for which the MDDT is qualified, the stage of device development, and the specific role of the MDDT.

FDAlogoCDRH is developing a qualification process because it provides a mechanism for leveraging advances in regulatory science, encouraging MDDT development and adoption, and “facilitating faster, more efficient device development and regulatory evaluation,” the draft guidance states.

However, the guidance intentionally stays away from any specific evidentiary or performance expectations the agency would have for qualifying a specific MDDT.

FDA is accepting comment and suggestions for revising the guidance until early February 2014. Electronic comments should be sent to http://www.regulations.gov.

 

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