In the 1971 song, “Signs,” the Canadian rock band, Five Man Electrical Band sang, “Sign, Sign, Everywhere a Sign … Can’t You Read the Sign?” The lyric resonates with us periodically as we discuss with a client a response from the Food and Drug Administration that seemingly surprises the client but, if the company had carefully read the agency’s correspondence or listened during a meeting or a telephone call, it would have seen the signs.
Recently (although it happens not infrequently), a client received comments from FDA that the agency would delay approval of a marketing application. The company was angry, frustrated, and miffed that the response came, in its opinion, from out of the blue, and FDA had blindsided the firm. However, upon review of the written communications, we failed to understand what was so surprising. Phrases, such as, “We strongly recommend,” “we suggest,” “we do not agree with your conclusion,” “a meeting may help,” or other subtle clues may indicate that FDA has concerns which portend a review of approval delay.
Whether it is an FDA inspectional observation, a comment during a pre-IND or pre-IDE meeting, or advisory comments, it is not uncommon for FDA to use language that signals its preference or concern. While the agency will not say, “Do this and you’ll be fine,” a carefully and meaningful review of what is said or written can offer significant guidance or insight into FDA’s current thinking on a specific matter. It doesn’t necessarily require a reading between the lines or a perusal of the proverbial tea leaves.
AGG Observations and Recommendations
Here are some observations:
- An FDA “recommendation” may not be a requirement. An FDA “should” doesn’t necessarily mean “shall.” However, a company should consider the agency recommendation. If a company chooses not to follow an FDA suggestion, it should consider an alternative approach or response, explain why the agency concern may not apply in the particular case, or even educate the agency, to address the underlying issue. One should not simply ignore FDA. As we remind clients, FDA is not always right, but it’s good to be FDA.
- FDA is not a company’s consultant. However, the agency’s comments may reflect that it has seen this movie before, and it knows how it ends. In short, FDA may be saving your company from itself.
- It is human nature to be wedded to what one says or writes. We know what we mean, so we expect that everyone else does. However, it is important to remember that we can get too close to something and lose objectivity. It may be worthwhile to seek a second pair of eyes and ears to review a situation anew. A fresh perspective and experience with a particular issue can be beneficial.
- An FDA comment or suggestion is not a personal attack. The agency doesn’t expect the company or data to be perfect, but it has standards and expectations. One should check ego at the door and listen.
Sign, sign, everywhere a sign. Can’t you read the sign? Sometimes, it’s right in front of you.