Congressman visits Perrigo

Rep. Welch hears FDA concerns on trip to Georgia baby formula plant

Perrigo Nutritionals Vice President Sean Walsh  shows Rep. Peter Welch (D -  Vt.) one of the Georgia plant's laboratories on Monday, March 10. (Photo by Jacqueline Cain)

Perrigo Nutritionals Vice President Sean Walsh shows Rep. Peter Welch (D – Vt.) one of the Georgia plant’s laboratories on Monday, March 10. (Photo by Jacqueline Cain)

On a trip to the Perrigo Nutritionals plant in Georgia on Monday morning, Rep. Peter Welch (D- Vt.) learned about the company and its products and how to help them.

“I was unaware of what they did, and it’s impressive,” said Vermont’s only House representative, who, along with his Deputy State Director Jon Copans, chatted with a handful of quality and operations specialists for about 40 minutes.

Before taking a brief tour with Vice President of Operations Sean Walsh, Welch learned the history of the factory, built in the industrial park off Skunk Hill Road in the early 1980s, right next door to a former state-owned whey plant. The baby formula company has thrived through several owners, said Walsh, who came over from Ireland in 1980 to manage the whey facility.

Perrigo’s formula is sold under a variety of labels, including store brands for national retailers. Annual sales, at home and abroad, are about $250 million for the company that employs 380 people, Walsh said. Less than two years ago, Perrigo invested $29 million in a new packaging system, he added.

Walsh met the congressman at a public event last summer and invited him to the factory. Welch made the stop on Monday morning, in between one of his regular Congress in Your Community events at a Fairfax bakery and riding along with St. Albans Police Chief Gary Taylor.

Though learning about Vermont employers is part of his job, Welch said he appreciates learning when and how he can help them overcome policy hurdles.

For Perrigo, employees are concerned with proposed changes to infant formula regulations. Two provisions the U.S. Food and Drug Administration is considering would substantially increase the company’s production costs and time without boosting safety, Director of Quality Matthew Sliva told the congressman.

The proposal is especially concerning since infant formula is Perrigo’s only export, and it is the smallest such producer in the country, Walsh added.

One new rule would require undertaking a full, clinical study for all new products – even if one added nutrient makes the product “new,” Sliva said, despite Perrigo’s current FDA-approved safety protocol. Each study can cost “a couple million dollars,” he added.

During a visit to Perrigo Nutritionals' Georgia plant on Monday, March 10, Rep. Peter Welch (D - Vt.) learns about new plastic packaging from the company's vice president, Sean Walsh. (Photo by Jacqueline Cain)

During a visit to Perrigo Nutritionals’ Georgia plant on Monday, March 10, Rep. Peter Welch (D – Vt.) learns about new plastic packaging from the company’s vice president, Sean Walsh. (Photo by Jacqueline Cain)

The other change would be more cumbersome, requiring manufacturers to test all batches of formula for shelf stability and other quality measures; current regs only mandate testing the first batch with periodic checks on subsequent ones, Sliva said.

Sliva estimates that would increase testing tenfold and require more storage space.

“It’s absolutely not necessary and adds no value,” Walsh said. “It simply adds cost, enormous cost.”

Production costs would be passed onto consumers and even taxpayers and the federal government, through the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC), used to support low-income families with good nutrition, Walsh said.

Sliva added the industry does support other proposed updates.

The International Formula Council, the association that represents manufacturers and marketers like Perrigo, is drafting its response, due later this month. The FDA plans to implement updated regulations this summer, Sliva said.

Welch was responsive to the employees’ concerns, saying regulation should be reasonable, not “just a bunch of rules for the sake of peace of mind for the rulemakers.”

Welch said he would address the matter with his colleagues who represent other states with formula manufacturing companies.

Perrigo employees also told Welch that Vermont’s high cost of living presents a competitive disadvantage to hiring the best talent. Welch said he hears this often but doesn’t have much sway in state policies like the property tax rate.

“I can hear your frustration: You’re doing good work, and it’s tough to stay competitive. I see our job in Washington is to be helpful so you can do your jobs back here,” he said, renewing his vow to advocate for sensible statutes.

“I’m amazed – with 300[-plus] jobs, you are critical to the local economy,” he said.

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