Download What Regulatory Writers Can Learn from Mark Twain

What Regulatory Writers Can Learn
from Mark Twain
Karen Kurt Teal, PhD
Does this describe your feelings about writing for FDA? Every new assignment looms as a
difficult task. In spite of how much you know and how long you have worked in the regulatory world, you cannot shake a sense of impending doom each time you sit down to write
something new.
Take heart, because you are not alone.
Other people who write for a living turn to reliable guides for inspiration. One of those
guides is American humorist Mark Twain, who has cheered weary fiction writers and readers for years, but who also offers sage advice for technical writers, including regulatory
writers. See sidebar.
“Say” what he is proposing to say, not merely come near it.
This rule seems straightforward but it is not, at least according to people who review
Investigational New Drug (IND) applications, reports and preclinical statements for the US
Food and Drug Administration (FDA). Let’s talk about biologics and making changes to formulas, equipment and processes.
Kristen Vadheim, PhD, RAC, president of Biocompliance Consulting, served as a
preapproval inspector at FDA’s Center for Biologics Evaluation and Research (CBER).
Vadheim remarks, “It’s kind of surprising that these people send changes [to a product]
to the agency and they don’t say what the product is.” These can be major changes, yet,
“because no company makes just one product,” it can cause confusion regarding an
essential piece of information. This omission is an embarrassing problem for a sponsor
company to have to address. Furthermore, Vadheim stresses that the regulatory writer
must get to the point as fast as possible and show how any conclusion was reached. “Did
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you flip a coin? Draw straws? Put the
product on stability? Do lab scale mockups? It’s really important to say ‘this is
what we did’ and ‘this is how we know
the effect on the product.’”
Use the right word, not its second
cousin.
According to Mark Twain, a writer should….
• “Say” what he is proposing to say,
not merely come near it.
• Use the right word, not its second
cousin.
• Eschew surplusage.
• Not omit necessary details.
• Avoid slovenliness of form.
• Use good grammar.
• Employ a simple, straightforward
style.
To pick the right word, you actually need
to turn to a native English speaker
and not your thesaurus. Not even the
Oxford English Dictionary can help you
when it comes to choosing words that
From “Fenimore Cooper’s Literary Offenses.” North
can help you get the FDA approval you
American Review, 161, July 1895.
seek. Vadheim recalls a native Germanspeaking doctor who was struggling to
explain his point, and who turned to the
thesaurus for a quick idea. What he needed to say was that his team “seeks to answer.”
What he wrote was “forages for an answer.” While “forage” does mean “seek,” it suits only
the food-gathering context and brings to mind images of animals rooting for truffles. Be
sure to have a native English speaker check the suitability of your word choices before you
submit documents to FDA.
Eschew surplusage.
When Twain humorously reminds us to “eschew surplusage,” he means “avoid excess.”
He picks the most awkwardly archaic terms to make his point: an overly elaborate word
calls attention to itself and away from the idea. Here is an example of excessively elaborate language.
You might think this is a pretty good sentence:
“By means of successful rotation, we were able to access the nut product.”
But what you really mean is:
“We twisted the top of the jar and had peanut butter.”
The point is, choose the most direct terms or risk losing readers. Elaborate, unfamiliar
words put off readers. Are you willing to risk losing your reader’s attention?
Not omit necessary details.
About omitting details: have you ever wished someone had told you before a public activity that the event was cash only? Your reader experiences the same kind of surprise when
you forget to show all the parts, components or arrangements that must be included in
your project. Misjudging the audience leads to all kinds of communication snafus daily.
Why? You cannot always assume the reader understands the entire picture and the
details. Therefore, it is really up to the writer to figure out what the reader does not know
and supply that information.
Before you start writing, spend time considering who is going to read your submission at FDA. Joy Cavagnaro, PhD, DABT, RAC, and past chair of the Regulatory Affairs
Professionals Society (RAPS), explains it this way, “All kinds of people with all sorts of
backgrounds review submissions. They are physicians, researchers and high school teachers.” During her eight years (1989–1997) at CBER, Cavagnaro served as safety topic
lead and rapporteur for the International Conference on Harmonisation Preclinical Safety
Evaluation of Biotechnology-Derived Pharmaceuticals, or ICH S6. Cavagnaro reminds writers that their FDA reviewer typically will not have as much specific background as they do.
Also, there are few toxicologists in the preclinical area, so regulatory communicators need
to explain why they included particular tests. It’s common sense to anticipate what the
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reviewer may not understand about your work and provide ample background information
and explanations.
Avoid slovenliness of form.
Sadly, a certain amount of messiness has crept into daily communications in regulatory
affairs. We tend to jump into the middle of a subject without adequately introducing it or
connecting it to an event. We also use too many acronyms. They are unavoidable for long
and beastly terms, and they are also easily scrambled. Here are just a few of the ones
that get mixed up: ISO, International Organization for Standardization (not IOS, the iPhone
operating system); CRF/CFR, case report form/Code of Federal Regulations; HIPAA (commonly misspelled HIPPA), which is the Health Insurance Portability and Accountability Act
(not the Health Insurance Privacy and Accountability Act).
Then there are the acronyms that stand for different things in the same field: ICD,
informed consent document/implantable cardiac defibrillator. The compounding horror is that
certain initialisms (that’s the correct term for creating terms from the initials of the words)
are used frequently in different fields and can cause trouble when audiences are mixed: IP,
investigational plan (to a regulatory person), intellectual property (to a research and design
person); CAD, coronary artery dissection (to a clinician or researcher) and computer-assisted
design (to the biotechnician helping to design a heart valve.) When you do use an acronym or
initialism, give a parenthetical definition on first mention. When writing to FDA, remember that
no one at the agency knows all the acronyms and initialisms in any given field.
Use good grammar.
We are also growing slovenly in our grammar. At a recent Washington Biotechnical and
Biomedical Association meeting in Seattle, speakers Steven W. Frantz, PhD, DABT, senior
principal study director, general toxicology at MPI Research, and David Brewster, PhD,
DABT, senior director, head toxicology/pathology at Vertex Pharmaceuticals, expressed
dismay over poor grammar usage in communication. This problem is not news to senior
managers, who list weak writing skills as their top complaint when asked about job candidates and employees.1 But how do we even approach this problem? Well, I can tell you
that your grammar corrections are probably just one or two proofreading checks away.
For instance, make sure your subject agrees with your pronoun. If you are not sure, ask a
trusted native English speaker to check your document.
Problem: GlaxoSmithKline offers their wide range of products to the world.
Fixed: GlaxoSmithKline offers its wide range of products to the world.
Problem: Every person has to have their ticket.
Fixed: Every person has to have a ticket.
Make sure the length of a “whole subject” or longer subject phrase does not confuse you
in your choice of verb. For example, The notion that different types of personalities can
change over time are just misguided. The real subject (notion) is singular, so the verb must
be singular. Another example of this grammar error is the accident that happens when
the writer becomes overly influenced by another noun in the sentence: There are some
aspects of the report such as safety that does not get full attention. The subject here
is plural (aspects). Many members of senior management simply shiver over grammar
errors, so do your homework. If you feel uncomfortable about your grammar, there are nononsense guides that you can easily find on the shelves of local bookstores or online. A
few suggestions appear at the end of this article.
Now, about your vocabulary: do not employ a word you do not use frequently without checking the dictionary first. Here’s an example of what I mean: meretricious. What
does it mean? You are probably thinking “merit.” Unfortunately, it is far from that. It
means “whorelike.” The right word is “meritorious.” Another confusing word is “enervate,
which means “to weaken.” Anne Macaulay, the managing editor of The Journal of Clinical
Anesthesia, says she sees “enervate” misused for the word “energize.” We need to go
back to the dictionary because our memories and our interpretations can stray far from
the real meanings.
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Employ a simple, straightforward style.
Of course, this is easier said than done. If you have not seen simple, straightforward writing or had it pointed out to you, how would you know what it is?
Think of the English sentence as a noun-verb unit. The unit is strong as long as the
noun is next to its verb. Strong: An advocate battles for justice. The chemical reacts with
air. Your reader has problems when you add words between the subject and the verb.
Weak: “The challenge when attempting to create an organ is that every individual has body
parts of a unique size and shape specific to themselves.” Do you notice how that italicized
phrase slows your reading down?
Here’s another: “In addition, long-running sentences interspersed with equations that
would cause havoc for a general audience, are right at home in an expert’s comfort zone.”
Take it easy with a reader’s patience. Sure, your reader is pretty smart. But he or she is
also taking multiple phone calls and reading five other reports. Try to keep your sentences
short and effective.
One last, very important, note: keep far away from the influence of marketing language
when you write your reports. David Hammond of Hammond Clinical Trial Consulting warns
against using the word “cure”—especially in the case of cancer—and the statement that
a drug or device does “well.” These words are the words marketers would like to use, but
that FDA frowns upon.
Here is some hard-boiled advice from Martha A. Feldman, RAC, and the president
and CEO of the Drug & Device Development Company Inc: “Say your company produces
a medical device that can measure oxygenation of blood. You cannot make the claim ‘We
measure it better than x.’” Why? “The FDA must give clearance on all claims. You can only
say what the device does and in what circumstance and population. That’s why representatives at trade shows always have those third-party research reports available, but only
under their tables.”
Remember, when you are seeking approval, if you make very specific claims in your
reports, the FDA will slow down your submission—and if the writing makes too many
marketing-like claims, FDA could restart or suspend the review clock. When a device or
medication has reached the premarket approval stage, there is much more evidence of
effectiveness, the company can make more specific claims.
Of course, you could always try to write using marketing flair. But be forewarned that this
is a dangerous choice, and that Mark Twain has something to say about this kind of experiment: “A man who carries a cat by the tail learns something he can learn in no other way.”2
References
1. Hart Research Associates on behalf of the Association of American Colleges and Universities (2010). Raising the Bar:
Employers’ Views on College Learning in the Wake of the Economic Downturn. Accessed 18 January 2013.
2. Applewhite A, Evans W, Frothingham A, ed. And I Quote: The Definitive Collection of Quotes, Sayings, and Jokes for the
Contemporary Speechmaker. Revised Ed. New York: St. Martin’s Press; 2003; 71.
Recommended Reading
•
Alred G, Brusaw CT, Oliu WE. Handbook of Technical Writing. 10th ed. Boston, MA and New York, NY: Bedford St.
Martins; 2012.
•
Gough J. Write It Down: Guidance for Preparing Effective and Compliant Documentation. 2nd ed. Boca Raton, FL,
London, UK, New York, NY and Singapore: Taylor & Francis; 2005.
•
Kane T.S. The Oxford Essential Guide to Writing. New York, NY: Berkley; 2000.
About the Author
Karen Kurt Teal, PhD, teaches technical writing in the University of Washington’s Biomedical Regulatory Affairs Master of Science
Program. She has been affiliated with the program for four years and is a member of the Organization of Regulatory and Clinical
Associates. She has a background in professional and technical communication.
Acknowledgements
Special thanks to Martha A. Feldman, RAC, and president and CEO of the Drug & Device Development Company Inc.; Thomas
Hazlet, PharmD, DrPH, director of the Biomedical Regulatory Affairs Master of Science Program of the University of Washington;
David Hammond, principal consultant, Hammond Clinical Trial Consulting LLC; and Anne L. Macaulay, managing editor, Journal of
Clinical Anesthesia.
© 2013 by the Regulatory Affairs Professionals Society. All rights reserved.
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