Plans For New Pharmaceutical Company In Works For W.Va.

West Virginia native and entrepreneur Crystal Mersh announced the development of a new pharmaceutical company.

The Department of Homeland Security has identified the supply of pharmaceutical drugs to the United States as a critical concern. Much of the prescription generic drug supply is made in foreign countries, raising serious worries about supply chain interruptions.

West Virginia native and entrepreneur Crystal Mersh hopes to help fix that. At Thursday’s 2022 Women’s Leadership Summit at the Greenbrier, Mersh announced the development of a new pharmaceutical company.

“American Medicines Company will provide medicines for the American people for chronic disease,” she said. “Medicines that we take everyday. Things for high blood pressure, for diabetes, for thyroid, for heart disease.”

Mersh explained that the company has been in “stealth mode” for eight months while it worked through regulatory issues. After a 25-year career in the industry, she said some of those issues were a challenge for her and her management team.

“What we’ve been doing the past eight months, is really getting our business plan together, getting our development plan together, and starting pre-formulation development on some of these drugs, working with the different federal agencies on pathways and funding strategies,” she said. “So we’re well on our way. And the next step is to locate a manufacturing site.”

Mersh said the company has looked at a number of potential locations for the facility, but it has several more possible locations to review. She expects to employ between 500 and 600 people in high tech manufacturing jobs when the plant is up and running.

The issue of creating a supply of generic drugs for the American public that can’t be held up with shipping issues or international problems is a serious concern for Mersh.

“These are really medicines that are life sustaining, life extending for the American public,” she said. “And right now, the situation is that the majority of those, and we estimate it to be greater than 95 percent, are manufactured offshore. So we want to bring manufacturing back to the U.S. and make American-made medication for Americans.”

EpiPen Costing Too Much? Here's How You Get the Alternative

Barbara Hollinger is allergic to yellow jackets. A few years ago, she was paying  about $50 for several packs of EpiPens, the brand name for a device that delivers a lifesaving dose of epinephrine after an allergic reaction. Then a pack of two became $300, then $600 – so she did some research online and asked her doctor to write a prescription for a generic epinephrine autoinjector. A day later, the pharmacy called and said it was ready.

 

“And it was $616,” she said. “I said, ‘That can’t possibly be right. What’s in the package?’ and [the pharmacist] said, ‘an EpiPen,’ I said, ‘That’s not what my prescription is for.’”

“There is such a thing as a generic epinephrine autoinjector; however, there’s no generic to the actual EpiPen,” said Dr. Michelle Knight, associate professor of pharmacy at the University of Charleston Pharmacy School.

In order for a medication to qualify as a generic substitute, it has to be almost exactly like the brand name product, just without the brand. Mylan, the company that makes EpiPen, has said it will release a generic version of the EpiPen in “a few weeks,” although no date has been set.

“So the name of this product that there is a generic to is called Adrenaclick,” said Knight. “It’s another brand-name product, but the difference between that and an EpiPen is that it does have a generic that is available”.

Adrenaclick’s generic cannot be substituted for the EpiPen because the injection device is different, though the medication inside is exactly the same. So if you have a prescription for an EpiPen, you will have to buy an EpiPen. If you want the generic version, your prescription has to read like Hollinger’s – generic epinephrine autoinjector – and you have to hope that the pharmacist will fill the prescription as written and not offer the readily known EpiPen.

“Epinephrine is a medication that has really been around for decades, it’s just the EpiPen has become the most popular formulation of epinephrine,” said Knight. “The reason for that is a lack of competition. There were some other brand-name products on the market like Auvi-Q and Twin Jet, but they were recalled due to some dosing and device issues.”

Because EpiPen is the oldest and most well-established autoinjector on the market, Knight said doctors trust the device to do what it is supposed to, and have just started prescribing it by the brand name.  Some may not even know that a generic autoinjector exists.

Which is the issue Barbara Hollinger ran into at her pharmacy. Her pharmacist eventually found and ordered the generic. Hollinger returned to the pharmacy a few days later to pick it up.

“Instead of the $616 EpiPen, I had to pay $5 for my generic alternative,” she said.

It’s important to note that Hollinger has an insurance plan that covers almost the whole cost of the generic. Of the 17 pharmacy representatives I talked to, all but one said they either had the generic or could order it. Some pharmacists, however, had never heard of the generic until I asked them to check their system.

Cash prices for the generic varied widely from pharmacy to pharmacy. The highest I found was $561; the lowest was $382. However, there was some variation within companies as well – even the same company within the Charleston area. Online prescription coupons brought down the price further.

In an email, one company spokesman said that drug price differences between pharmacies are due to a variety of “local and corporate factors.” He did not respond to an email asking for clarity about what those factors are.

Appalachia Health News is a project of West Virginia Public Broadcasting, with support from the Benedum Foundation.

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