Regulatory Focus™ > News Articles > PhRMA: FDA Labeling Guidance May Run Afoul of First Amendment, Discounts Value of 'Trade Dress'

PhRMA: FDA Labeling Guidance May Run Afoul of First Amendment, Discounts Value of 'Trade Dress'

Posted 30 July 2013 | By Alexander Gaffney, RAC

The pharmaceutical industry group Pharmaceutical Research and Manufacturers of America (PhRMA) is calling on the US Food and Drug Administration (FDA) to make several changes to a recent guidance for industry document intended to reduce medication errors by standardizing the way information is displayed on labels and cartons-not just the labeling itself.


The guidance document, Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors, was released in draft form on 23 April 2013, and is related to several safety initiatives from the last decade. The most notable of those efforts may have been a 2006 report by the Institute of Medicine (IOM), which identified several problems as contributing to medication errors and patient harms.

Those eight factors were:

  1. The names of drug products can sound or look the same, causing consumers to consume the incorrect product.
  2. The same drug may have several formulations, which means consumers might take the wrong dose or be prescribed the incorrect product.
  3. Abbreviations on the product labeling might be used to represent several similar concepts.
  4. Symbols, derivatives and abbreviations could be confused.
  5. Labels are difficult to read because they are cluttered and use small fonts and illegible text.
  6. Company logos are too prominent and distract from more important information.
  7. Warnings and reminders are not properly or adequately emphasized.
  8. Terminology is not adequately standardized.

FDA was given additional authority to regulate the use of proprietary names, label abbreviations, acronyms, dose designations, and error-prone labeling and packaging designs in 2007 under the Food and Drug Administration Amendments Act (FDAAA), and in 2010 held a meeting to study how it should interpret its new authority.

The Guidance

The guidance itself is relatively straightforward. In it, FDA notes that poor label design is, as IOM reported, a safety issue. To combat these problems, applicants and sponsors are advised to make sure the primary display panel of a product-the panel most likely to be displayed to the end user as the "front" of the package-displays the proprietary name, the proper name, the product strength, the route of administration and any warnings or cautionary statements.

The guidance also establishes recommendations regarding the container label size, minimum standards for font size and style (12-point sans serif-type font such as Arial), the use of high-contrast backgrounds and un-crowded text information that avoids the use of logos, bars, stripes, watermark graphics, lines or symbols.

Logos should be small and unobtrusive, FDA advises. In addition, abbreviations should not be used so as to avoid confusion. FDA noted that µg-the symbol for microgram-can often be mistaken for milligram for consumers, raising the potential of a massive overdose. Other abbreviations, such as IU, a measurement, have been mistaken for IV, a route of administration.

In other areas, companies need to be cognizant of the visual representation of their products. The use of two similar packages-for the sake of example, green, the same size and shape, and bearing the same graphics-could cause consumers or healthcare providers to accidentally prescribe the incorrect one to patients. As such, changes should be made-and in particular to the color-to distinguish various strengths and dose forms of a particular medication.

The guidance goes on to note a host of other issues, such as specific format recommendations for displaying the branded and generic name of a product, expiration dates, national drug code numbers, scheduling letters and product strength.

PhRMA: Guidance Suspect under First Amendment

PhRMA, one of the industry's most prominent trade groups, wrote that the guidance is in need of some changes in a response sent to FDA's Federal Register docket on 2 July 2013, and may even be constitutionally suspect.

That argument is one that has been put forth by PhRMA in the past. For example, a letter submitted to FDA in May 2012 in reference to a draft guidance on DTC television advertising cited the Supreme Court case of Central Hudson, noting that in the absence of a "narrowly tailored" and "compelling state interest," no government agency could curtail free speech rights, including those of corporate entities.

PhRMA advances a similar argument in its 2 July 2013 letter to FDA, noting that the way a package looks on the outside-its "trade dress"-"can be considered a protected form of non-verbal communication," giving it First Amendment protections under the Bill of Rights. To do otherwise would impose "arbitrary and unduly restrictive limits on the use of trade dress on container labels and carton labeling design," the group wrote.

For example, in lines 211-212 of the guidance document, FDA notes that "information about business partnerships should not appear on the label or labeling." PhRMA argues in the letter that this "unduly" restricts free speech "without showing that a particular label design will decrease text size and prominence and cause important information to be difficult to read and/or easily overlooked." The lines should be deleted, PhRMA wrote.

Dressed to Impress: The Value of 'Trade Dress'

The brunt of PhRMA's arguments, however, concern the value of so-called "corporate trade dress," a term commonly understood to be the unique packaging characteristics that make you recognize a product as being associated with a particular company, brand or product.

PhRMA noted that the "trade dress" of a package can serve to identify the product and help avoid consumer confusion, adding that the guidance seems to disfavor the use of trade dress. This was further complicated by what the letter states is FDA's different approach to the definition of trade dress. In FDA's definition, it is only concerned with the "manner in which" a company packages a product. PhRMA argued that it is less the manner and more its purpose: to identify a product to the consumer.

"In other words, trade dress functions the same as a traditional trademark and is used by consumers to help identify a company's product and distinguish it from the product of another. As a result, pharmaceutical trade dress done well supports, rather than detracts from, medication safety."

PhRMA goes on to request that FDA "instead analyze each label on an individual basis in the context of its use," adding that trade dress can be "employed in a manner that is legible, readable, easy to understand and actually serves to reduce dispenser confusion."

PhRMA's comments to FDA may be found on FDA's Docket website.

PhRMA Comments to FDA

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