The wait is on

NAPLES, Fla. – Lawn care operators always want new products to battle emerging weed pressures, but the process of manufacturing those products might take nearly a decade’s worth of work.

At Bayer’s recent Focus on Florida event, company officials gave media a glimpse at what goes behind establishing a new product. When the company develops something with a new active ingredient, the rigorous process involves somewhere between 120 and 180 studies. Scientists might screen up to 10,000 different molecule compounds, and field trials. None of that’s to mention how getting approval from the Environmental Protection Agency can take years, and EPA often tweaks its own deadlines to accommodate for backlogged requests.

And if a case study goes poorly somewhere along the way? The whole project is sunk, and the company might be out millions of dollars with nothing to show for it.

“The cogs are turning. It’s a huge investment in time, money. It’s just tremendous,” said Sheryl Wells, one of Bayer’s field development representatives. She previously worked in the pharmaceutical industry and said studies on how the product affects air or water quality don’t pertain to her last line of work. “There’s more studies and more requirements for a product in this industry than there is in the products that you put in your body, like the drugs that you take.”

HOW IT STARTS. Bayer’s scientists will develop thousands of chemical compounds in the process of finding just one that will make it to commercialization. Those scientists will narrow down the options to just a handful for field trials, which Wells said must be kept secret to protect the company’s intellectual property.

This process alone takes four or five years as product development representatives define how the product actually works: They help answer questions like how well does it mix? What’s the viscosity like? Does it go in suspension and will it stay in suspension? Does it have a smell when mixing or applying? They’ll send the product back to scientists, who will tweak the product to prevent small details like strong odors or discoloration on nearby hardscapes.

Though fungicides are often tested up north, many of these trials on herbicides are conducted in Florida, where Bayer has several testing facilities. This is also because of the state’s distinct climate that promotes the growth of various weeds and pests.

“If a pest exists,” Wells said, “it happens here (in Florida).”

GETTING THE GREEN LIGHT. Around the seventh year of production, a team of regulatory officials at Bayer will start compiling a dossier to submit to the EPA. This could include hundreds of pages of data that needs submitted, and it could take two or three years to even get approved.

If approval is achieved, it doesn’t take long after that until a product is launched. Sales managers start doing large-scale demonstrations to convince users that the product will be worth purchasing. The patent life on a product ranges between 17 and 20 years, so Bayer officials said their sales team have the disadvantage of only having the remaining seven to 10 years after a product hits the market to make up for millions spent on development.

But the headaches don’t often end once the regulatory team submits the dossier. The EPA is required to set dates by which they have to take an action, though the action doesn’t mean deny or approve the new active ingredient. The action could be that they request more trials, or it could be that they are pushing back the decision date even further.

“You’re basically at the mercy of the (EPA),” said Mike Ruizzo, a Bayer regional sales manager. “We’re sitting there waiting, waiting, waiting, waiting – the clock’s still ticking, we don’t get an extension on patent life. So, if it takes an extra year, we just lost another year in the marketplace.”

There are also regulations on how to advertise a product before it’s officially registered. Companies can talk about the product in a technical way, like giving the facts on what it should help with once it’s out, but they can’t talk about it promotionally. Or, companies can announce they’ll be releasing a new product and give its name, but they won’t be able to say more about what it does. Once you pick one of those paths, you have to stick with it.

All of this amounts to what Bayer officials believe is a tough sales climate. “Two or three failures,” Ruizzo said, “and you’re out of business.” Plus, he said other companies making generic versions of their products can simply cite the original company’s case studies and manufacture their own versions of the product once it receives government approval. This essentially undercuts the first company’s sales teams by offering cheaper alternatives without having spent as much money on it in the first place.

“As long as we can spend to do this kind of thing, there will be new products for lawn care operators,” Ruizzo said. “If things change and get so bad that it’s super restrictive for us to bring new products to the market, there’ll be a lot less tools for the lawn care operator to use.”