Regulatory Focus™ > News Articles > 10 Takeaways from FDA's 2013 Warning and Untitled Letters: 5 - 1

10 Takeaways from FDA's 2013 Warning and Untitled Letters: 5 - 1

Posted 18 June 2013 | By

Here at Regulatory Focus, we read a lot of the Warning Letters and Untitled Letters issued by the US Food and Drug Administration (FDA). In fact, we try to read every single one of them related to pharmaceuticals, medical devices, biologics or dietary supplements.

Why? Because they're often the best way to get a sense of what the agency cares about and where it may be preparing to shift its resources. Several times during the first half of this year, Focus has identified Warning Letters that have preceded crackdowns on companies for similar violations.

We recently went through all Warning Letters and Untitled Letters issued since 1 January 2013 with one question in mind: What should regulatory professionals take away from these letters?

We're pleased to present a list of 10 takeaways from what we think are the most interesting and most important letters sent by FDA this year (so far). [Parts 10-6 may be found here.]

5.) The Mysterious Warning Letter

One of the most intriguing Warning Letters sent so far this year was one we know very little about. If that sounds weird, it's because it very much is, but it's important to understand regardless.

The backstory is this: Sometime in April 2013, the law firm Hyman, Phelps & McNamara petitioned FDA to hold off on posting a Warning Letter to an unspecified company. The company's gripe, as communicated through the petition, was that the letter reveals too much information about its intellectual property. If released, it said, it could jeopardize "confidential information and/or trade secrets" as defined under federal law. The rest of the letter is pretty interesting as well, with the company alleging that part of the letter references a product over which the agency has no jurisdiction since it is intended for sale outside of the US.

The one thing we do know: The letter was posted. In a follow-up posted to FDA's federal docket website shortly after the original petition was posted, HPM noted that the petition was now "moot" because the letter had been issued. [Read More…]

The Takeaway: Warning Letters can contain information that is sensitive to a company and in particular its trade and intellectual properties. It is important to review letters for information that may be deemed sensitive, and if need be appeal FDA's decision to post a Letter on its website.

4.) Tag-Team Trouble

If you read Warning Letters regularly, you may be accustomed to seeing just one name affixed atop the letter: the US Food and Drug Administration. But if you were paying close attention in January and February 2013, you were exposed to something special in the form of rare, multi-agency Warning Letters.

In the midst of a turbulent influenza season marked by spot shortages of flu vaccines and treatments like Tamiflu, US regulators said they became aware of several companies attempting to pass off unapproved products as ways to prevent or treat the influenza virus.

While several of the companies selling those products received a Warning Letter from just FDA, several others received one co-signed by the Federal Trade Commission (FTC) as well. A January letter to Cold Defense LLC was the first to receive the letters, with regulators citing violative materials found on the company's website. [Read More…]

FTC would ultimately sign on to two additional FDA Warning Letters, with FTC signing onto those that appeared to be vitamin products with trumped-up efficacy statements. [Read More…]

Focus flagged the letters as a rare anomaly, and a review of FDA's Warning Letter database shows that FTC hadn't signed onto a Warning Letter since November 2011 at that point in time. As with the 2013 flu outbreak, FTC had stepped in to help FDA in 2011 to stop companies that were selling products meant to treat the herpes simplex virus without first receiving FDA approval to do so.

The Takeaway: If your products break the regulations of multiple agencies, prepare to receive Warning Letters signed by multiple agencies as well. While FTC and FDA don't often co-sign Warning Letters, when they do it typically indicates the launch of a rigorous and targeted enforcement effort you don't want your company to be caught in the crosshairs of.

3.) Search Engine: FDA Isn't 'Feeling Lucky'

Most Warning Letters sent to companies reference specific products or advertisements, such as brochures, pamphlets, or text on a website, but a February 2013 letter to Medical Doctors Research (MDR) references something rather unusual: an association made through a website search.

"Typing the key word 'cancer' or 'diabetes' into MDR's product search field located on its website" brings up a number of products, FDA observed - a problematic observation given that none of the products made by the company are actually intended for cancer. The warning letter indicates that regulatory officials are intent on targeting those associations - when they're able to be found, that is.

SEO-savvy regulatory folks might do well to ask themselves, in the classic words of Google, if they're "Feeling Lucky" enough to risk noncompliance. [Read More…]

The Takeaway: In an age where metadata and search terms can lead to business, FDA seems intent on making sure that companies are presenting their products fairly in all ways. Make sure your company's website isn't using unfair associations or keyword tagging, or you could find yourself with a Warning Letter as well.

2.) FDA Doesn't Like a Company's Facebook 'Like'

As with every other Warning Letter posted on this list, we're proud to say we were the first publication to break news that FDA had sent a Warning Letter to a company in which the agency cited it for "liking" an unapproved claim regarding its product.

Facebook, a social media website on which users can post a comment, story or other media, allows users to express their approval or recognition of a story by clicking a "Like" button, shown in the form of a thumbs-up icon. It had long been a matter of speculation in the social media world whether a "like"-or on Twitter, a "re-tweet"-represented an endorsement of the content, or just a passive-but-friendly recognition of that content.

In the Warning Letter sent to AMARC Enterprises in February 2013, FDA comes down strongly on the former interpretation, saying that the company's "like" of a patient testimonial was a violative claim on the part of the company. [Read More…]

The Takeaway: The Warning Letter to AMARC should clarify once and for all a simple truth: It's the message, not the medium, that matters most to regulators. Just as with a company's website, where posting a patient testimonial regarding an unapproved claim would be banned, so too is an endorsement - in this case, a "like" - on Facebook a violation of FDA's advertising regulations. Companies need to be careful when maintaining a social media account, as one wrong click on a "Like" or "Retweet" button could lead to a Warning Letter or worse.

1.) You Can't Drop Your Responsibility off at the Park (Doctrine)

If there's something to take away from the previous nine Warning Letters we've covered during this countdown, it's likely this: You need to pay attention to the Warning and Untitled Letters posted by FDA, even when they're sent to companies that operate in industries outside of yours.

Case in point: A series of Warning Letters sent in May 2013 to five dietary supplement companies indicating that FDA isn't happy with companies for allegedly contracting out not only their manufacturing operations, but also their oversight over those operations as well.

"Although your firm may contract out certain dietary supplement manufacturing operations, it cannot, by the same token, contract out its ultimate responsibility to ensure that the dietary supplement it places into commerce (or causes to be placed into commerce) is not adulterated for failure to comply with dietary supplement CGMP requirements," FDA wrote in all five letters.

And lest companies think this doesn't apply to them, know this: FDA's citation for this reasoning is derived directly from the Park Doctrine, which states that a person who delegates their responsibility to others may still be found to have engaged in criminal wrongdoing should they fail to exercise appropriate oversight. [Read More…]

We found these letters curious, to be sure, but the subsequent weeks cemented in our minds the importance of these letters, with FDA releasing a new guidance document for the manufacture of drugs on 28 May 2013 that deals with the exact same issue [Read More…] and an "Advisory Action Letter" - basically a Warning Letter - to a veterinary pharmaceutical manufacturer days later using the same language used in the supplement letters. [Read More…]

The Takeaway: FDA often starts addressing problems in trial populations before moving on to larger targets. By paying attention to letters addressed to manufacturers in different industries, you can often make sure you stay ahead of similar problems before FDA begins a wider crackdown.

In addition, FDA's Warning Letters make clear that it thinks ultimate responsibility for quality lies with the entity sponsoring the production and distribution of the products. If a company can't define what quality should look like and doesn't test the final product before distribution, it can expect an unfavorable response from regulators if ever they come knocking on a facility's door.

That's all for our Top 10 countdown! Enjoy this list? Check out numbers 10 - 6, posted here, and let us know what you think on our social media accounts on Twitter, Facebook, LinkedIn and our Regulatory Exchange. 


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