December 22, 2014

Medical Device Cybersecurity Risks Are The Wrong Kind of Halloween Fright

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Well, Halloween is approaching boys and girls. And while it’s fun to don a Dracula (or Miley Cyrus) costume and get some yucks faux scaring folks, the FDA is acting like a responsible parent by setting up a medical device cybersecurity educational seminar later this month in Arlington, VA. It appears to have filled up already, but a webcast recording will be made available.

Getting a tiny adrenalin rush when a nine-year-old Frankenstein jumps out at you in the dark is one thing; finding out some nineteen-year-old hacker has infiltrated your proprietary product and customer information isn’t the right kind of fright.

Seems like someone out there in the bureaucracy has a little sense of humor, because October is National Cybersecurity Awareness Month. FDA, along with the Department of Health and Human Services and the Department of Homeland Security, hope to bring together a wide swath of stakeholders, including medical device makers, to their Oct. 20-21 “Collaborative Approaches for Medical Device and Healthcare Cybersecurity.”

Participants will be encouraged to help regulators identify barriers to promoting medical device cybersecurity; discuss innovative strategies to address challenges that may jeopardize critical infrastructure; and enable proactive development of analytical tools, processes, and best practices by the stakeholder community in order to strengthen medical device cybersecurity. It’s shaping up to be a good agenda, but it’ll probably only be as strong as the attendees who show up to share war stories and discuss best practices with regulators and others.

iStock_000020037007SmallBroadly speaking, the symposium hopes to help advance medical device cybersecurity by swapping information about the most current online threats, identifying gaps, advancing usage of the feds’ “Framework for Improving Critical Infrastructure Cybersecurity”, and developing tools and standards to build robust, comprehensive protection programs, among other areas of focus.

One of the topics will be the FDA’s new guidance “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices,” released Oct. 2. That guidance provides some helpful definitions (helpful in the sense that this is how the FDA views the world), and what kind of cybersecurity protection program the agency expects from medical device makers and their kin.

Some say the threat of medical device security hacks has been hyped up a bit. I’m no expert there. But a report issued earlier this year from a cyber expert at SANS Institute (sponsored by cybersecurity vendor Norse), says some 94% of medical institutions report being victims of some type of cyberattack. This isn’t a report specifically about medical device makers, and I’m certain the vast majority of the attacks were relatively small and easy to thwart. Regardless, those numbers deserve some attention.

Hyped or not, I don’t imagine you’ll see an attendee at FDA’s event getting a jump on Halloween and showing up dressed as a sophisticated hacker, though. That’s just too scary.

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FDA Proposals Take a Fresh Look at Some Stale Food Issues

Tamar June

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

That landmark Food Safety Modernization Act (FSMA) just keeps getting more and more important. Earlier this month, the FDA unveiled four proposed amendments that will likely make a tough law even tougher.

FSMA, signed into law in January 2011, is designed to tighten food safety regulations and shift the focus to a proactive mindset and away from FDA’s relatively reactive approach in years past. FDA has now proposed seven rules to implement FSMA. This new wave of proposed revisions target four areas: produce-safety; preventive controls for human food; preventive controls for animal food; and the foreign supplier verification program.

The action follows FDA’s May announcement it was engaging in the rule-making and guidance development process required to establish the new prevention-oriented standards. FDA implementation teams have developed a slew of ideas for how the agency can better oversee the food industry, strengthen the global food safety system, and enhance protection of public health. Planning has also begun for the next phase of FSMA implementation, which involves advancing new public health prevention standards and implementing the strategic and risk-based industry oversight framework at the heart of FSMA.

In just part of what could go into effect next year, FDA calls for revisions to the foreign-supplier verification proposed rule. It aims to give importers more flexibility to determine appropriate supplier verification measures based on risk and previous experience with their suppliers.

Arguably, one of the more important FDA proposals is a new call to develop current Good Manufacturing Practices (cGMPs) more applicable to the animal food industry, provide flexibility for a wider diversity in the types of animal food facilities, and establish standards for producing safe animal food.

foodsafety570However, human food processors already complying with FDA human food safety requirements, such as brewers, would not need to implement additional preventive controls or cGMP regulations when supplying a by-product (e.g., wet spent grains, fruit or vegetable peels, liquid whey) for animal food, except for proposed cGMPs to prevent physical and chemical contamination when holding and distributing the by-product (e.g., ensuring the by-product isn’t co-mingled with garbage). That noted, further processing a by-product for use as animal food (e.g., drying, pelleting, heat treatment) would still require compliance with the preventive controls for animal food rule.

FDA’s new amendments would also make exemptions a bit clearer, and raise the requirements defining a “very small business.” To be considered tiny, a firm must post less than $2.5 million in total annual sales of animal food, adjusted for inflation. FDA expects that exemption to apply to just over 4,000 facilities.

The proposed rules also address some supplier issues. FDA wants new controls addressing those occasions when the receiving facility’s hazard analysis identifies a significant hazard for a raw material or ingredient, and that hazard is controlled before the facility receives the raw material or ingredient from a supplier.

If these new FDA proposals become the law of the land, the facility would have flexibility to determine the appropriate verification activity (such as onsite audit, sampling and testing, review of supplier’s records) unless there is reasonable probability that exposure to the hazard will result in serious adverse health consequences or death to humans or animals.

Industry and any other interested parties have some time to weigh in on the FDA’s proposals. The FDA will accept comments on the proposed revisions of the four proposed rules for 75 days starting next week (September 29) while continuing to review comments already received on the sections of the proposed rules that are going to change. The agency will consider all comments before issuing final rules sometime next year.

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The FDA is Reading Your Facebook Page and They Don’t ‘Like’ What They See

Tamar June

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

In a previous post we looked at the FDA’s relatively ho-hum guidance on social media. Since then, the agency has issued an interesting warning letter to a Utah-based dietary supplement maker for, among other alleged infractions, “liking” off-label claims made about its product on Facebook.

In its warning letter, the FDA has determined that the supplement maker’s website promotes conditions that cause products to be drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)] and that the products are intended for use in the cure, mitigation, treatment, or prevention of disease. Examples of violation in the warning letter include:

  • “[C]linically supported to work fast and offer congestion relief so you can breathe better in every season”
  • “Proven congestion relief”

But it doesn’t stop there.

The FDA then continues with the company’s Twitter page, pointing out additional “evidence” that their products are indeed intended for use as drugs because the page has a direct link back to the company’s website where products can be purchased. The letter provides two examples of tweets that bolster the FDA’s case.

  • On February 7, 2014: “Try @Zarbees #naturalremedies for Cold and Cough Season…”
  • On January 30, 2014: “RT@MomCentral Have you tried #ZarbeesCough for cold and cough relief?”

And then there’s Facebook.

Once again, the letter points out the website link from their Facebook page where these products can be purchased. According to the FDA’s letter, “Your Facebook page also contains evidence of intended use in the form of personal testimonials recommending or describing the use of products for the cure, mitigation, treatment, or prevention of disease.”

The FDA also specifies nine instances of the company “liking” or replying to comments made by satisfied customers claiming various degrees of symptom relief or cures.

facebook Is this warning letter a blip, or could it be the start of a new FDA online enforcement trend? Because this one was sent to a dietary supplements maker, an industry segment that plays it pretty loosey goosey with claims in the first place, it’s not clear whether this kind of scrutiny will spill over into the medical device and drug market segments. We’ll keep an eye out and report back as newer warning letters emerge.

Customers can praise your products all they want, but don’t you dare “like” any of them.

As interactive technology and social media increasingly plays a prominent role in advertising and promotion, the FDA has attempted to issue several draft guidance documents at the request of industry. These include:

Guidance for Industry: Internet/Social Media Platforms with Character Space Limitations—Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices is intended for using Twitter and sponsored links in Google or Yahoo that have character limitations.

Guidance for Industry: Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices is intended to provide guidance regarding a manufacturer’s voluntary correction of misinformation that is “created or disseminated by an independent party.”

Guidance for Industry: Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics extends guidance beyond traditional print media to websites, chat rooms, forums, etc.

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FDA IDE Guidance Offers Industry Important Clarity

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

In its August 19 guidance for Investigation Device Exemption (IDE) Clinical Investigators, the FDA attempts to better outline its thought process for reviewing, accepting, accepting with conditions, or denying an IDE. It can literally be a matter of life and death for patients and trial subjects. Thus, the agency and industry continue to take it seriously.

FDA approval of an IDE allows the initiation of subject enrollment in a clinical investigation of a medical device that has potentially significant risks — widely defined as a device that could pose a serious health risk or death to the user, is used to support to prolong life, or is part of a diagnosis tool also being used to support or sustain life.

The guidance covers a number of important areas, some with new wrinkles, including:

IDE Decisions

FDAlogoFDA must inform sponsors or sponsor-investigator of its decision, or must notify the sponsor that the investigation may not begin, within 30 days from the date of receipt of the IDE application, or the IDE application will be deemed approved. If an IDE application is approved or approved with conditions, the sponsor may begin subject enrollment, up to the number of subjects and investigational sites specified in FDA’s decision letter, upon receipt of Institutional Review Board (IRB) approval, which may occur prior to FDA approval.

IDE Approval

An IDE application is approved if FDA has determined that: the sponsor has provided sufficient data to support initiation of a human clinical study; no subject protection concerns preclude initiation of the investigation; and no additional conditions must be met. 

IDE Approval with Conditions

FDA has clarified matters here somewhat, and appears to have given industry a touch more leeway if used wisely and safely.

If FDA approves an IDE application with conditions, the sponsor may begin subject enrollment upon receipt of IRB approval and in accordance with the limits described in FDA’s decision letter, including the maximum numbers of U.S. subjects and investigational sites, and must submit information addressing the issues identified as conditions of approval in FDA’s letter within 45 days.

An IDE application is approved with conditions if FDA has determined that: the sponsor has provided sufficient data to support initiation of subject enrollment in a human clinical study; no subject protection concerns preclude initiation of subject enrollment; but additional conditions must be met to address certain outstanding issues.

Previously known as “conditional approval,” the phrase “approval with conditions” is now used to convey that the outstanding issues do not raise concerns that preclude FDA from granting approval for initiation of subject enrollment in the clinical investigation. FDA now says resolution of those issues isn’t required prior to initiation of subject enrollment in the study, except for certain issues related to the informed consent document.

The guidance reiterates how seriously FDA takes clear, simply informed consent forms for trial participants, noting it “closely reviews” those as part of an IDE determination.

Staged Approval, Staged Approval with Conditions

In the guidance, FDA says it may grant IDE approval or approval with conditions for a portion of the intended study cohort, enabling certain outstanding questions to be answered concurrently with enrollment in this cohort. Staged approval permits the clinical investigation to begin in a timely manner while maintaining appropriate subject protections. In some cases, the sponsor proposes a staged enrollment in the IDE application. In other cases, the sponsor requests approval for the full subject cohort but the agency may decide to grant staged approval for a limited number of subjects as an alternative to outright disapproving the IDE.

IDE Disapproval

Broadly speaking, little has changed here in regards to what the FDA deems most important in an IDE request. If the agency raises patient risk issues the device company cannot adequately address, and/or if the device maker is unable to persuade the FDA that the product is important enough (e.g. life-saving) to quality for IDE designation, it will get the thumbs down.

FDA Communications

The agency says it will send a letter discussing any rejection or question about an IDE request. The letter should include the agency’s thoughts on how the study design assessment, considerations, and other suggested improvements the device maker should consider if it plans to try again.

 

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Cyber Security and Reliability Assurance Initiatives Top Priority at NERC Board Meetings

 

Trey Kirkpatrick, Vice President, Energy & Utilities Compliance, AssurX Inc.

Vice President, Energy & Utilities Compliance, AssurX Inc.

NERC held their Board of Trustees (BOT) and Member Representatives Committee (MRC) meetings in Vancouver, BC on August 13 – 14, 2014. The meeting included lively discussions on all the initiatives underway at NERC and impacting all the Registered Entities. Two of the most talked about topics were the CIP Version 5 transition and the Reliability Assurance Initiative (RAI). NERC is dealing with some very tight timelines on both of these initiatives.

The CIP Version 5 transition involves a continuous outreach program that includes conferences, workshops and training. NERC is working with the CIP auditors to ensure consistent application of audits and enforcement. A CIP Auditor Workshop is scheduled for September 2014. These will address areas of industry concern and enable input into guidance documents. There is also an effort for the coordination with CIP version 5 revisions and the Reliability Assurance Initiative. Project 2014-02 continues to be a priority for NERC and the industry as well as the new CIP Reliability Standard Audit Worksheets (RSAWs) documents. NERC and the industry are still moving forward to ensure they meet the FERC deadline of February 2015 with the required revisions to the CIP Version 5 standards.

ElectricitySunsetBlue150The Reliability Assurance Initiative (RAI) Progress report was discussed at the NERC BOT Compliance Committee meeting. The RAI has gone through various joint pilot programs with NERC, Regional Entities and Registered Entities that volunteered for the pilot programs. The RAI is focused on risks to reliability; enforcement resources are focused on noncompliance that poses a serious and substantial risk to reliability. There are many aspects to this initiative including Compliance Exception Program and Aggregation/Logging Program. The release of the RAI documentation for industry comment is coming out soon. There were questions regarding the quick turnaround for comments. NERC said that would evaluate this to ensure that the industry has enough time to comment. The RAI program will be a work in progress as it is implemented. The timeline of January 2015 is quickly approaching with lots of activities that still need to take place.

The presentation given at the NERC BOTCC meeting was very detailed and included some important slides from various regions and registered entities from the pilot programs.

Other important discussions that took place involved:

NERC and the industry are going through some major implementation challenges in 2014 and 2015. The meetings in Vancouver included some very important discussions and what impact it is having on resources, strategic direction of the ERO, and the impact all this has on reliability to the grid.

Click here to request to view the AssurX CIP Solution Webinar.

 

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FDA Guidance Advises Device Makers to Think About Home-Use

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Medical device manufacturers would be well-advised to address any potential home-use products risk at the design state, says an August guidance from the FDA.

As the agency notes, “Failure to adequately consider potentially hazardous situations during the design of home use devices may result in inappropriate use, use error, or incompatibilities between the use environment, the user, and the device. This could cause the device to malfunction, possibly contributing to death or serious injury.”

It could also make the FDA really angry.

The guidance offers advice designed to address then entire manufacturing process — and beyond. It covers environmental issues, user issues, design issues, human factors, labeling challenges, postmarket considerations, and the always fun human factor

Digging a little deeper into the guidance, FDA covers many layers of these topics, including:

  • Environmental considers such as location, contaminants, water supply, temperature, dampness and humidity, atmospheric pressure changes, air flow, travel and international use, fluid exposure and storage.
  • User considerations such as physical location, sensor/perception requirements, plus cognitive and emotional product demand.
  • Design issues, including lock-out mechanisms, maintenance and calibration, mechanical issues and special emphasis of electrical issues. As noted earlier, this is probably the section deserving the closest examination by medical device makers.
  • Human factors ranging from user training to certifications.
  • Labeling issues including describing the basic handling of the device, how to dispose of it in an emergency, disposal, and hygienic maintenance.
  • Post-market considerations such as robust customer service and medical device reporting.

electronic document managementFDA’s Medical Device Reporting (MDR) regulation requires manufacturers to submit reports to the FDA whenever it becomes aware of information that reasonably suggests that a device it sells may have caused or contributed to a reportable death or serious injury, or has malfunctioned and the malfunction would be likely to cause or contribute to a reportable death or serious injury should it recur.

For the FDA Form 3500A, instructions for completing specific items on the form, and the coding manual see MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

For additional guidance on the MDR regulation and the reporting requirements refer to FDA’s guidance Medical Device Reporting for Manufacturers (March, 1997). FDA advises medical device manufacturers to also take a look at its draft guidance Medical Device Reporting for Manufacturers (July 9, 2013).

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FDA Spreads Regulatory Love Nationwide

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Detroit may be struggling with bankruptcy, but in a flurry of activity that would make industrialist Henry Ford proud, the local FDA office has been active in our latest warning letter round-up.

Indiana-based Med-Mizer, manufacturer of AC powered, adjustable and bariatric hospital beds, was hit by FDA’s Detroit office with a 12-point letter dated July 21.

Among FDA’s accusations, Med-Miser failed to:

  • Establish procedures for reviewing and evaluating incoming complaints
  • Develop, conduct and control and monitor its production process
  • Establish and maintain design controls
  • Validate a manufacturing process
  • Ensure its products meet acceptance criteria

Ventilab LLC, a manufacturer of manual resuscitation bags based in Grand Rapids, was also dinged by the Detroit office for CAPA shortcomings, inadequate complaint management, and failing to establish an acceptable risk management plan.

warning640Moving east to the City of Brotherly Love, FDA’s Philadelphia District office sent a warning letter to the maker of a sleep apnea monitor citing it for failure to ensure its device conformed to specifications and requirements. That June 30 letter was the result of a series of April 2014 inspections.

A June 27 letter called out Zynex Medical, manufacturer of the NexWave multiple mode electrical stimulator and the IF8000 electrical stimulator for perceived CAPA and design control and verification shortcomings. Zynex, baed in Lone Tree, Colorado, was also hit for failure to have adequate device master records and internal audit procedures.

Out in Napa, California where the weather is lovely and the wine flows, June 25 was probably not a day to celebrate for Dexta Corporation, manufacturer of medical chairs used for Lasik surgery and other procedures. FDA hit them for, among other things, failure to adequately train personnel, inability to verify test results, CAPA issues, and process controls problems.

Henry Ford, a man who tried to build his own utopian city in the jungles of the Amazon and modestly name it Fordlandia, would be proud of the FDA’s devotion to hard work these past few months. Perhaps there is an FDAlandia on some city planners drawing board just waiting for the green light. You never know.

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FDA Lets MDDS Off The Regulatory Hook

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

Michael Causey, Editor & Publisher, eDataIntegrityReport.com

FDA won’t enforce compliance with regulatory controls that apply to medical image storage devices (MDDS) and medical image communications devices recognizing the “low risk” they pose to patient safety and the importance they play in advancing digital health.

The good news came in a guidance released June 20, “Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices.”

Specifically off the hook are MDDS’ subject to 21 CFR 880.6310, medical image storage devices subject to 21 CFR 892.2010, and medical image communications devices subject to 21 CFR 892.2020. Devices in these categories won’t be subject to FDA regulatory enforcement regarding registration and listing, premarket review, postmarket reporting and quality system regulations.

As defined by the FDA, MDDS is a medical device intended to store and/or move edata without controlling or altering the functions or parameters of any connected medical device.

 

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Unprecedented Energy Demand on Aging Grid: Important Discussions at NYISO Energy Conference

Trey Kirkpatrick, Vice President, Energy & Utilities Compliance, AssurX Inc.

Vice President, Energy & Utilities Compliance, AssurX Inc.

New York Independent System Operator (NYISO) had their 2014 Energy Conference in New York City at the end of June. The topics this year included; addressing the aging infrastructure, grid modernization, distributed resources, and fuel diversity. The panelists were a mix of industry experts from utility executives, a university professor, and government experts.

Steve Whitley, President and Chief Executive Officer of the NYISO, talked about the ongoing energy trends taking place in the northeast and the rest of North America. There are historic patterns of electricity demand that are being influenced by extreme weather patterns, the sluggish economy, and the adoption of more efficient energy technologies. Mr. Whitley discussed that within a span of six months, New York State set two seasonal records for peak electrical loads. Those two involved the summer heat wave in June 2013 and the Polar Vortex in January 2014. New York State successfully met these two extreme challenges by maintaining reliability and not resorting to emergency measures.

When it came to the panel discussions, there was plenty of dialogue for the need of fuel diversity. With coal being phased out in most of the northeast and no nuclear expansion planned, natural gas is the primary fuel source for electricity generation. With one of the coldest winters in years, natural gas price spikes and operational challenges demonstrated the need for coordination between the electrical and gas industries. Many of the panelists called for stronger regulatory policies because of the growing dependence on natural gas in North America for electric generation.

electricityTowersOrangeDistributed energy resources were also discussed along with the aging infrastructure. More than 80 percent of New York’s high-voltage transmission lines went into service before 1980. New York State studies estimate that this will require replacements over the next 30 years costing an estimated $25 billion. On the other hand, photovoltaic systems in New York State increased by over 40 percent from 2012 to 2013. Wind generation in the state continues to grow requiring utilities to complete transmission upgrades to move the power from upstate New York to southeastern New York like the Lower Hudson Valley, New York City, and Long Island.

These are all good examples of what many utilities, independent power producers, and government entities are dealing with across North America. As day-to-day energy use and peak demand diverge, this impacts wholesale electric markets, grid operations and planning, as well as, demand-side management programs.

We are all concerned with electric reliability. There are new standards for physical security and cyber security. More stringent requirements are being implemented for system protection maintenance for the bulk electric system. The utilities and independent power producers are assessing and revising their internal controls and programs so that issues are being identified earlier, mitigated and tracked to completion. They are also implementing new risk management programs so that the high and medium risks are receiving the required attention from their executives.

The electric industry has many changes ahead of them in the coming years. There will always be new competition, extreme weather and new technologies, but the companies that are addressing these issues and taking the proper actions will end up being stronger and more resilient. These initiatives benefit all of us, as customers, with a resource that we cannot live without.

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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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