Life Science Compliance Update

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30 posts from May 2009

May 31, 2009

FDA: Pharmaceutical Cheerios?

I did not realize there were negative side effects or addiction problems with Cheerios but apparently the FDA thinks Cheerios are drugs.

With all of the health care reform legislation coming close to an initial framework, and with numerous federal agencies working with the Obama Administration and Congress to present these outline to the public one would suspect that agencies such as the Food and Drug Administration (FDA) were using their resources and time wisely.

Not these guys, instead of focusing on the safety of the food supply or developing a swine flu vaccine, the FDA recently felt the need to attack one of America’s favorite foods: Cheerios.

As disclosure for this article my kids love Cheerios, one of my daughters is allergic to gluten and this is one of the only cereals she can eat along with Rice Krispies. w\We even have a song that we sing in the morning cheer-e-o-o-o-o-oos. But there is a down side, I end up stepping on them pretty regularly, and hearing the cheerios crunch, the end up all over the car, behind the seats in crevasse. Last Saturday I spent an hour cleaning Cheerios up in our van.

The FDA’s mission to cleanse society of those annoying little O’s began in early in May, when the FDA issued a letter to Ken Powell, Chairman of the Board and CEO of General Mills. According to the letter:

“The Food and Drug Administration (FDA) has reviewed the label and labeling of your Cheerios® Toasted Whole Grain Oat Cereal. FDA's review found serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and the applicable regulations in Title 21, Code of Federal Regulations (21 CFR).”

Moreover, the FDA determined based on claims that on the product's label, that Cheerios® Toasted Whole Grain Oat Cereal is promoted for conditions that cause it to be a drug because the product is intended for use in the prevention, mitigation, and treatment of disease. Specifically, the FDA asserted that the Cheerios® product bears the following claims on its label:

• "you can Lower Your Cholesterol 4% in 6 weeks" "
• "Did you know that in just 6 weeks Cheerios can reduce bad cholesterol by an average of 4 percent? Cheerios is ... clinically proven to lower cholesterol. A clinical study showed that eating two 1 1/2 cup servings daily of Cheerios cereal reduced bad cholesterol when eaten as part of a diet low in saturated fat and cholesterol."

As a result, the FDA claims that Cheerios® is considered a “new drug” because it is not generally recognized as safe and effective for use in preventing or treating hypercholesterolemia or coronary heart disease, and therefore, it may not be legally marketed with the above claims in the United States without an approved new drug application.

The FDA further argues that although the other cholesterol claim is on the same panel as the authorized health claim, its prominent placement on a banner in the center of the front label, together with its much larger font size, different backgrounds, and other text effects, clearly distinguish it from the health claim in the lower left corner. Consequently, this allowed the FDA to call Cheerios ® a misbranded product because it bears unauthorized health claims in its labeling, and because the website bears the following unauthorized health claims:

"Heart-healthy diets rich in whole grain foods, can reduce the risk of heart disease."

Apparently, the claim leaves out any reference to fruits and vegetables, to fiber content, and to keeping the levels of saturated fat and cholesterol in the diet low, and thus does not convey that all these factors together help to reduce the risk of heart disease and does not enable the public to understand the significance of the claim in the context of the total daily diet.

Ultimately, General Mills, Inc. was told to advise the FDA in writing within 15 days regarding the specific steps they will take to correct the violations noted above.

General Mills though is not rolling over in a statement earlier this month stated:

Cheerios’ soluble fiber heart health claim has been FDA-approved for 12 years, and Cheerios’ ‘lower your cholesterol 4% in 6 weeks’ message has been featured on the box for more than two years.  The science is not in question.  The scientific body of evidence supporting the heart health claim was the basis for FDA’s approval of the claim, and the clinical study supporting Cheerios’ cholesterol-lowering benefit is very strong.  The FDA is interested in how the Cheerios cholesterol-lowering information is presented on the Cheerios package and website.  We are in dialog with FDA, and we look forward to reaching a resolution."

As shocking and ridiculous as this letter is, what is even more frustrating is that Cheerios® is trying to help people become healthier. Instead of acknowledging the significance this cereal can have in making people healthy, (the FDA must want us all eating sugary cereals such as Captain Crunch with Crunch Berries, or Sugar Smacks) the FDA chose to classify a cereal as a ‘drug.’

Moreover, this is a miss allocation of resources the FDA could be out figuring out ways to stop childhood obesity where foods actually could be considered drugs (such as candy and soda), and helping the Health and Human Services Department figure out new ways to educate people, the FDA is actually going after the good guys.

Where does the FDA find the time to . The FDA needs to get their priorities straight soon. Healthy eating is one of the core missions of this organization, and attacking a brand like Cheerios ® is not only wrong, but sets a bad example for other companies not to produce healthy foods because of the risk (unnecessarily) associated with their product. Cheerios as a drug (does this now mean I should ban them from my house) – give me a break!! What’s next, fruit, fiber?

May 29, 2009

FDA: Presenting Risk Information in Prescription Drug and Medical Device Promotion (2009) Draft Guidance

This week, the U.S Food and Drug Administration (FDA) issued a draft Guidance for Industry titled "Presenting Risk Information in Prescription Drug and Medical Device Promotion." Within this document, the FDA describes factors it considers when evaluating advertisements (ads) and promotional labeling for prescription drugs, ads for restricted medical devices, and promotional labeling for all medical devices for their compliance with the Federal Food, Drug, and Cosmetic Act and relevant regulations.

The draft guidance discusses factors that are relevant to the disclosure of risk information and provides numerous examples to illustrate FDA’s thinking on these factors.

As the guidance asserts, the FDA believes it is critically important to disclose risk information in prescription drug and medical device promotion appropriately and effectively to healthcare professionals and consumers.

Current industry guidelines encourage manufacturers to develop prescription medicine promotion that is "designed to achieve a balanced presentation of both the benefits and the risks associated with the advertised” product.

However, according to the FDA omission or minimization of risk information is the most frequent violation of the regulations cited in advertising and promotion enforcement letters sent to sponsors. In addition, research in one of the areas the guidance covers, direct-to-consumer prescription drug advertising, has shown that 66 percent of patients believe ads directed at them do not provide enough information about risks, 60 percent of physicians believe that patients have little or no understanding from these ads about what the possible risks and negative effects of the products are, and 72 percent of physicians believe that patients have little or no understanding from these ads about who should not use the product.

LEGAL OVERVIEW

To comply with the FD&C Act and FDA’s implementing regulations, such promotional pieces:

  • Cannot be false or misleading in any particular

  • Must reveal material facts about the product being promoted, including facts about the consequences that can result from use of the product as suggested in the promotional piece; and

  • Should present information about effectiveness and information about risk in a balanced manner

As a result, when the FDA evaluates the risk communication in a promotional piece, FDA looks not just at specific risk-related statements, but at the net impression – i.e., the message communicated by all elements of the piece as a whole. The purpose of the evaluation is to determine whether the piece as a whole conveys an accurate and non-misleading impression of the benefits and risks of the promoted product.

GENERAL CONSIDERATIONS and CONSIDERATIONS OF CONTENT

In evaluating risk communication, the FDA considers the following:

  • Consistent Use of Language Appropriate for Target Audience

  • Use of Signals - Headlines and subheads are examples of commonly used signals

  • Framing Risk Information - how a particular piece of information is 268 stated or conveyed, such as by emphasizing either the positive or negative aspects of the information or 269 by presenting the information in vague versus specific terms.

  • Hierarchy of Risk Information - the ordering of risks within a presentation an important factor in determining the risk 310 profile conveyed by a piece

  • Quantity - the amount or quantity of information conveyed by a promotional piece. The FDA considers these factors when determining the comparability of benefits and risks in a piece:

  • The number of statements about benefits and risks

  • The completeness and depth of detail given about benefits and risks

  • The amount of time (in both the audio and visual portions) devoted to benefits and risks in a video, audio, or broadcast communication

  • The amount of space devoted to benefits and risks in a print communication

  • The use of audio or visual components that enhance or distract from the presentation of risk or benefit information

  • Materiality and Comprehensiveness - the degree to which information is objectively 390 important, relevant, or substantial to the target audience

CONSIDERATIONS OF FORMAT

FDA also considers formatting factors when assessing whether a piece is false or misleading such as:

  • The layout of a print promotional piece (generally, its plan, design, or arrangement)

  • Overall Location of Risk Information

  • Font Size and Style & White Space

  • Contrast between text and background should not highlight the benefit information more than the riskinformation.

  • Non-Print Promotion

Comments

Comments are due in 90 days by Friday August 21st, after which the FDA will release final guidance.

Submit comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.

For questions regarding this draft document contact (COER) Kristin Davis at 30 J-796- J200, (CBER) Ele Ibarra-Pratt at 301-827-3028, (CVM) Martine Hartogensis at 240-453-6833, or (CDRH) Ann Simoneau at 240-276-0100.

FDA Draft Guidance:Presenting Risk Information in Prescription Drug and Medical Device Promotion

FDA Draft Guidance:Presenting Risk Information in Prescription Drug and Medical Device Promotion

FDA: Presenting Risk Information in Prescription Drug and Medical Device Promotion (2009) Draft Guidance – Coalition for Healthcare Communication Solicits Your Input

The Coalition for Healthcare Communication will be filing extensive comments  on the FDA draft Guidance and solicits your expert guidance in that effort. For immediate public comment, please participate in the dialogue in the Coalition's LinkedIn Group: Click here to join the group and comment. If you are on the Coalition's email list, you have been pre-approved to join the Coalition's group.

To volunteer to participate in the formal Coalition comments, email: jkamp@cohealthcom.org.

While subject to some revision before final adoption, this should be treated at this point as being pretty close to a final document. Therefore, every drug and device company and every marketing partner needs to read the entire document and study this guidance carefully. A serious effort should be made to comply with its detailed proposals. For, like it or not, the safety of the nation’s drugs and devices is top of mind for the public today among both professionals and consumers. Moreover, advertising and other marketing tools covered by this guidance are among the important ways our profession will rebuild confidence in our industry and can help build patient adherence by communicating drug regimes that improve individual and public health.

Advertising professionals will instantly recognize that this guidance extends FDA’s unrealistic expectations of advertising and other marketing. Essentially this guidance demands nearly perfect messages and fully attentive audiences. The guidance expects the audience to be able to fully understand everything needed to either prescribe or initiate a doctor-patient conversation about a drug or device. As unrealistic as it is, that’s the FDA mandate, largely forced on it by the FDA Act, and reflecting the similarly unrealistic expectations of many citizens who are leaders of organized medicine, prescribers, patients and care givers.

Given these realities, the Coalition intends to (1) tell the FDA the truth about the realities of advertising, and to (2) make recommendations that will make the rules more realistic, practical and effective.

Most important, we look forward to a dialogue with the FDA that enables drug and device sponsors to communicate with prescribers and consumers more effectively about both the benefits and risks of health products.

We look forward to your recommendations and contributions to the Coalition comments. Remember, the FDA is a data and fact driven agency, so please include references to research and other scientific data wherever possible.

If you would like to join our discussion on this issue, please visit the Coalition's LinkedIn Group.

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