Editorial: Just what do you expect?

By Len Monheit, NPIcenter

[email protected]

As we head into what promises to be a busy July, I'm struck by the implications of the concept of setting and managing expectations. We see the impact in so many ways.

We expect certain things from our clients and our suppliers. We have expectations of our colleagues, staff and employers. In the industry, we have expectations of our leaders and trade associations. There are other sector or role -related expectations, whether you are a media, a manufacturer or a law firm. Truth be known, many individuals and groups consistently meet or exceed all expectations - and some even get recognized for it once in a while.

It has been said that the key to positive interactions regarding expectations involve communication - consistent, proactive and two-way. And while most of us would understand this concept as obvious, perhaps it's useful to examine our current environment and see the good, the bad and the non-existent.

In the United States earlier this year, a significant amount of focus was on New Dietary Ingredients, and while many were frustrated at what seemed to be increasing challenges in getting submissions 'not objected to', and while others suggest that FDA is not providing any clear guidance, the entire dialogue of a few months ago can be argued as part of an expectation-setting process, where industry and regulators were trying to better understand the landscape, and now industry is waiting to see what FDA does next on the subject. At the very least, industry is expecting something – it has expectations.

Other examples include AER's and GMP's.

The former, we are told is still under discussion and debate. The latter, we are told by the FDA, is still expected 'soon'. Presumably, most in the industry expect and even support an industry-wide AER (Adverse Event Reporting) system. On the subject of GMP's (Good Manufacturing Practices), industry's expectations are mixed. On the one hand, there's the 'got to see it to believe it' over the timing of the final rule. On the other hand, there is frustration and exasperation as companies deal with the fact that time is wasting, time that they could be effectively using to move solidly in the pin-point direction of ultimate compliance, whereas now they are only moving in the general direction since they don't know exactly what will be in the final rule. If the rule is significantly different (worse or more onerous) from what was presented a few years ago, FDA will have severely mismanaged expectations. If it is better, in that FDA has incorporated industry feedback, then that would meet or even exceed current expectations and set the tone for future dialogue.

In Canada, communication and turn-around times on correspondence with the Natural Health Products Directorate are apparently improving. One can argue that original expectations were not met and had the Directorate managed these expectations better, industry wouldn't have been as frustrated at the uncertain environment the new regulations created. One can also point out that the first year plus set industry's subsequent expectations so low that current performance standards exceed the revised expectations.

Some might say that the regulator needn't bother with the exercise of managing expectations, but the other side of this view is that industry does have a critical role to play in setting the regulator's expectations, a role often filled by the trade associations. It is true also, that increased compliance means, among other things, lesser enforcement burden, so there is an economic incentive for expectation management - for both sides.

Let’s switching gears for a moment to another area where managing expectations has met with mixed marks in recent years.

In an industry that relies heavily on shows and meetings, post show assessment and communication has typically been weak - a missed opportunity to manage expectations. On the other side, for some events, we have been conditioned to expect a poor function, where we only participate because we have to or because it's the right thing to do to support the industry, and are pleasantly surprised when our expectations are soundly exceeded. Industry veterans have the resource and experience base to make these decisions, it's the rookies whose expectations are frequently mismanaged, as we see when we observe first time exhibitors going full out and wasting precious resources at traditionally weak shows or inappropriate venues.

Mismanaging or not adequately managing expectations almost always has consequences.

Hide comments


  • Allowed HTML tags: <em> <strong> <blockquote> <br> <p>

Plain text

  • No HTML tags allowed.
  • Web page addresses and e-mail addresses turn into links automatically.
  • Lines and paragraphs break automatically.