From the Editor: Best Practices or Trade Secrets?

Security must be a top priority for drug makers, but overly restrictive noncompete and nondisclosure agreements and publishing practices verge on the paranoid – and prevent the exchange of “best practices” that the industry needs in order to improve.

By Agnes Shanley, Editor in Chief

Share Print Related RSS
Few companies guard intellectual property and trade secrets more zealously than pharmaceutical manufacturers. Their survival depends on it. Some have been burned in the past — Amgen, for example, allowed a team of Japanese journalists into one of its sites years ago, only to learn that they had been busy photographing documents, equipment and sensitive areas within the plant.

Anecdotes abound of trade secret theft by disgruntled or greedy employees. In other cases, people are simply careless or uninformed — researchers excited about their work share a bit too much with other colleagues, assistants pass documents on to former bosses. In the U.S., the Economic Espionage Act was passed nine years ago to help protect corporations against the financial impacts of trade secret theft, which are said to exceed $250 billion annually in the U.S. alone.

Companies have responded proactively, developing strong “nondisclosure” and “noncompete” agreements for anyone they hire. They’re also educating employees about what distinguishes a trade secret from other information.

The days are over when anyone could easily wander into any manufacturing plant, posing as cleanup or maintenance contractors or cooks, and poke around.

This is as it should be. But at times I wonder whether the security pendulum hasn’t swung too far in the other direction, toward the paranoid. Consider this case:  An expert who was downsized several years ago by a leading pharmaceutical company submitted an article to our magazine six months ago. The article discussed a technology that is widely used, and discussed it in very general terms, but drew important and interesting conclusions. It contained no trade secrets or sensitive information and nothing specifically related to his former employer.

Two months ago, he called to say that his former employer’s lawyer had heard that the article would be published and warned him that this would violate his nondisclosure agreement.

I also learned that the author had based the paper very loosely on a graduate thesis that he had developed while working at the company. The same employer had prevented him from publishing the thesis too, even though it did not disclose any proprietary information. He had to cobble up another project in its place.

Even though he no longer works for the company, the firm is still controlling his activities. This is excessive and unfair.

Also unfair are some of the noncompete agreements that are circulating these days, limiting employment opportunities if an employee should leave the company “for any reason.” This might be acceptable in a world where employers were more loyal to their workers, but not today, when anyone is expendable.

In any case, this guardedness challenges us as journalists. I can’t tell you how many times drug companies ask to review copy — and non-controversial copy at that — and vacuum anything remotely useful or interesting from it.

One article mentioned deviations that had occurred internally at a manufacturing plant over five years ago. Defective product was never released, but variability was seen and some batches trashed. The company had taken steps to improve that, and the article outlined how. The company, which had publicly presented this information, needed to strike from the written record the fact that it had ever seen those deviations. “What if FDA read the article?” they reasoned.

One company that was issued a consent decree several years ago resisted our efforts to discuss the very positive work it is currently doing, even though its staff had made numerous presentations on this subject at executive forums. “Too sensitive. We absolutely can’t print that.” Or, worse yet, “OK, but just leave our name out.”

I’m willing to bet that if we proposed a puff piece on “Dressing better on casual Fridays,” we’d get the same response. “I’m sorry. The khakis are proprietary.” Must everything be viewed as sensitive information conferring a unique competitive advantage?

Pharmaceutical manufacturing is at the threshold of huge change. It is only by sharing helpful information — not process recipes or trade secrets — that the industry’s manufacturing performance can be improved.

Not all of your companies belong to CAMP or CPPR. Not all of you can afford time away from your facilities to attend every industry meeting to network. Additional forums and avenues for information exchange are needed to promote discussion of “best practices” that can help manufacturing improve. We’d like to help — if you’ll let us.

Share Print Reprints Permissions

What are your comments?

You cannot post comments until you have logged in. Login Here.

Comments

No one has commented on this page yet.

RSS feed for comments on this page | RSS feed for all comments