Tag Archives: regulatory

SOCIAL MEDIA FOR SUPPLEMENT MAKERS (PART II)

SEVEN GOOD REGULATORY HABITS FOR COMPANIES ONLINE

In the last post we learned that FDA enforcement against supplement and nutraceutical makers based on their social media activity is no longer a hazy nightmare.  It has emerged into our recent reality.  What can supplement or natural products makers do to protect themselves from an FDA enforcement action while maintaining a presence in social media?   Below are some suggestions that apply to social media interactions as well as to more traditional sales and marketing activity. As always, please consult a regulatory attorney for more comprehensive advice, or contact the FDA for more information that relates to your specific product.

1. Develop a Social Media Policy

Your company lawyer (if you have one) may not see the many casual interactions on the company’s social media pages. However, your social media managers will, so it is important that they understand the boundaries of engagement with fans and how to handle and respond to fan comments. Include a reporting process for any potentially problematic interactions. While social media has memory, the employees who use it on behalf of your business should be trained on what to post, what to report internally, and what to delete. Even if your company does not use social media, your staff should be fully trained on how to respond to customer feedback and the appropriate use of testimonials.

2. Avoid Even the Appearance of Reliance on Risky Testimonials

The consuming public, and especially those who use social media, look for the opinions of others before deciding to buy. As such, testimonials present a double-edged sword. On the one hand, they make marketing easier, but in the marketing of regulated products FDA views them as “long-arm” extensions of product promotion. Therefore, testimonials should be carefully managed. A testimonial can’t be repeated if it makes statements on behalf of the company that your staff could not directly say without breaking promotional rules. General endorsements, such as “I love this product!” may not cause an FDA inquiry, but an endorsement that says “This product cured my impotence” is probably unwise.

3. Labeling, Labeling, Labeling.

On or off social media, the first and most basic step any company can take is to vet its labeling for compliance with FDA regulations. Your labeling includes the container, the carton and any inserts or standalone literature that you distribute which has information about the product. It also includes your web sites and any information you post on social media information pages. Therefore, all these should be reviewed to ensure there are no assertions about your product (referred to as claims) that cross the line into the “forbidden garden” of drug promotion. Avoid claims that state the product treats, cures, mitigates or prevents disease. That is sometimes harder to do than it may seem for a natural products company. What if you want to talk about the benefits of a well known natural product, like garlic? There may be rules or exceptions that apply to specific ingredients and to the ways in which you plan to use them. You may therefore want to consult a regulatory lawyer to get help in formulating your labeling strategy.

4. Be Clear About FDA Approval Status

Simply put, don’t claim that your product is “FDA Approved” if it isn’t. It doesn’t matter if your product contains an ingredient that has been approved under an FDA monograph, or is Generally Recognized As Safe for the same use for which it’s included in your product. If the public could read your product label and think that you received approval from the FDA to market the product that is actually in the container when in fact you haven’t, you probably won’t get away with it.

5. Don’t Overreach

Saying I can practice medicine because I watch medical dramas on television, no matter how many I’ve watched over the years, wouldn’t get me hired as a physician because I can’t show any proof of my skill as a doctor! By the same token, overselling your product by claiming it has attributes you can’t prove will attract problematic attention from regulators. In many cases, companies that received warning letters were also engaged in other behaviors that FDA probably considered too egregious to ignore. The agency’s job is to protect the public, especially vulnerable populations, from products that make promises they have not been clinically shown to satisfy. With this in mind, take a look at your product line. If your lineup includes products with claims that unabashedly recite drug-like action, such as “fights infections,” “cures diabetes” or “inhibits tumor growth,” please immediately consider a full labeling review. The overall posture of your company and product lines might make a big difference in whether or not you become a target for immediate enforcement action.

6. Be Prepared To Support Your Claims With Good Data

If you’ve taken the time to develop clinical studies and lab test results, you may be able to back up specific claims about your product, but that data by itself won’t exempt your company from the requirement that all products claiming to be “drugs” must first be approved. But maybe your product will fall into one of FDA’s many monograph categories, or it might be appropriate to initiate some dialogue with the agency to determine whether you have enough data to secure formal approval. You should absolutely vet your claims with a regulatory attorney or the FDA before you proceed.

7. Pay attention to your manufacturing and quality control

This is not so much a social media issue, but it does present an area in which we have seen an increase in regulatory activity.

Deanna Baxam is an attorney at Baxam Law Group, LLC.

This post is provided for information purposes only. It is not intended as a substitute for consultation with a qualified attorney.  Copyright 2014, Baxam Law Group, LLC. All rights reserved, please repost with attribution.
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Pfizer Takes Supplements

Pfizer®, that pharmaceutical behemoth of the late 20th century, announced today it is buying the consumer products business of Ferrosan, a Danish supplement maker.  The deal price was not disclosed, but according to Yahoo Finance, Ferrosan said its 2010 earnings were about $55 million.  That is small pickings for a company of Pfizer’s size, but it is yet another trickle in the shifting tides of big pharma’s business focus.  

Truly novel blockbuster drugs are few these days.  One could speculate ad nauseum on the reasons for this, but one possible cause is that the companies who invest money in bringing drugs to market don’t want to risk big money on unproven chemical entities and metabolic pathways that might also be a challenge to cautious regulatory reviewers like those at the FDA.  The results of this very conservative approach from the industry (and from the government)are drugs that for the most part improve upon or modify some known molecular structure or sequence that has shown some success in the past.  It is good business investment for the drug companies, but not so much for the consumers who need “disease preventers” instead of palliative treatments, and for those who are already sick and need a new therapeutic approach instead of a variation of the tried and true.

There is a new wave coming, and in my opinion big cures will be coming from natural products and botanicals in the early part of this century, so this is a good move on Pfizer’s part.  It’s good for consumers too, because big drug companies have the cash to do the studies that would support approval of natural products and botanical therapies, even by the most conservative of regulatory systems.  Let’s hope we see more moves like this. 

Read Pfizer’s press release

Other new product prototypes to watch include Dendreon’s Provenge® immunotherapy treatment for advanced prostate cancer.

FDA To Further Study Standardized Risk/Benefit Labeling for Drugs

The Patient Protection and Affordable Care Act requires the Food and Drug Administration (FDA) to determine whether adding quantitative summaries of the risks and benefits of a prescription drug medication in a standardized format would help healthcare providers and consumers make better decisions about using the drug.  For the better part of the last decade, FDA has been discussing whether the types of information now provided are sufficient to advise these decisions.  Currently, a patient package insert (PPI) is required for some classes of drugs, or if there is a risk evaluation and mitigation strategy (REMS) in place for a high-risk drug; otherwise it is voluntarily submitted by manufacturers for other products.  A medication guide is usually required to be distributed with the drug if there is a REMS in place.

While the PPI and the Medication Guide are often required to be distributed, consumers may also be given consumer medication information (CMI). CMI is developed by drug manufacturers according to general guidelines provided by FDA, but is not subject to the same distribution requirements or oversight when used in association with products.

For most of the last decade, FDA has been evaluating the effectiveness of these types of written prescription drug information, and the agency has held several public meanings to discuss the matter with the industry.  Among the issues being looked at is the report that most patients prefer written information rather than numerical data; and numbers, percentages and statistics might be difficult for the consumer to understand unless they are presented in a simple, straightforward organization.  Patients most prefer verbal communication about a drug’s risks and benefits, but relying on this as a primary means of communication could increase the risk of inaccurate medication compliance. 

At the last meeting in 2009, FDA concluded that there are too many forms of written patient information, and that more study is needed to come up with a user-friendly format that would be sufficiently educational to the patient.  The healthcare reform statute supports this conclusion. Section 3507 of the statute directs FDA to continue studying whether providing quantitative summaries of the risks and benefits of each prescription drug in a standard format would be helpful to the process of making individual healthcare decisions.

Baxam Law Group, LLC

www.baxamlaw.com