Groups with Mylan ties fighting EpiPen bill

Ohio lawmaker wants to make an alternative device more accessible.

Credit: DaytonDailyNews

A pair of advocacy groups that get funding from the manufacturer of EpiPens are fighting an Ohio bill that seeks to make cheaper life-saving epinephrine auto-injectors more accessible.

EpiPens, which are manufactured by Mylan, dominate the market thanks in part to laws that restrict pharmacists from substituting alternative injectors. The cost of EpiPens have enraged some consumers, who complain they have little choice but to pay as much as $600 for a two-pack of the life-saving drug.

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House Bill 101 was introduced in February by Rep. Derek Merrin, R-Monclova Twp. Several pharmacy groups have testified before the health committee in support of the measure, saying it will lower out-of-pocket costs for consumers who need to have the injectors on hand in case of a severe allergy emergency.

In this Wednesday, Sept. 21, 2016, file photo, Mylan CEO Heather Bresch holds up EpiPens while testifying in a hearing before the U.S. House Oversight Committee. Last October, Mylan agreed to pay $465 million to settle Justice Department allegations that it overbilled Medicaid for its life-saving EpiPen allergy injection. (AP Photo/Pablo Martinez Monsivais, File)

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But two non-profits are opposing the bill, citing safety concerns that could arise if a patient is given a different brand auto-injector than one they’ve been trained to use by their doctor.

"In the moments of an anaphylactic reaction, it's critically important that patients be trained and familiar with that specific EAI device, because each of them is very unique in the way that you actually administer the product," said Tonya Winders, CEO of the nonprofit Allergy and Asthma Network. "Seconds count and the last thing we want is someone trying to fumble and figure out do I hold for three seconds instead of 10?"

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Both groups receive donations from Mylan, which stands to face increased competition if the bill becomes law.

“It’s very common for groups to be getting money,” said Peter Maybarduk, director of the Access to Medicines Program for consumer advocate group Public Citizen. He said the conflict of interest that creates has made it difficult for the public to push back against “price abuse” by the pharmaceutical industry.

More than 80 percent of the nation’s largest patient advocacy groups accept funding from drug and medical-device companies. For some of those groups, the donations accounted for more than half of their annual income, according to a recent study published in The New England Journal of Medicine.

A shot of Auvi-Q. A Centerville mother says she was able to get the treatment for her daughter at virtually no cost through a mail-order pharmacy. GREG LYNCH / STAFF

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“People have to choose between paying their grocery bills and paying for the care that they need,” Maybarduk said. “Who speaks for our interests in affordability when so many people stand to make money in our system as it exists today?”

‘No-brainer’

The Epinephrine Accessibility Act would allow Ohio pharmacists to substitute — with patient’s consent — a prescribed, lower-cost alternative epinephrine auto-injector. The justification for not allowing it now is that each brand’s device works slightly differently, though the drug inside is exactly the same.

The bill would also allow adults to purchase auto-injectors without a prescription in some situations.

“This bill will help and enable pharmacists to be able to have a conversation with consumers and inform consumers that there are other options available,” Merrin said. He said he crafted the bill after hearing stories of a $600 price tag for a two-pack of the EpiPen.

“We’ve been informed by pharmacists that the EpiPens have a high abandonment rate,” he said. “The physicians order the drug and the pharmacists get it, but patients don’t pick it up because of the cost.”

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Another part of bill is intended to save consumers money by not requiring them return to their doctor’s office every year to renew an existing prescription. It also would allow public places like restaurants and colleges to more easily stock the drugs for use in emergencies. Currently those entities are allowed to purchase non-patient-specific injectors, but only with a prescription.

In this July 8, 2016, file photo, a pharmacist holds a two-pack of the EpiPen epinephrine auto-injector. Mylan last year began selling a generic version of the emergency allergy treatment after the high price for the branded option drew public scorn and congressional inquiries. (AP Photo/Rich Pedroncelli, File)

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The Ohio Pharmacists Association, the Ohio Council of Retail Merchants, and pharmacists from Ohio State University and Kroger wrote letters or testified in support of the bill.

Centerville mom Amy Kress said the bill is a common sense solution for families like hers. Her daughter, Katie, is 13 and has a severe dairy allergy that requires her to have emergency epinephrine on hand at all times.

After paying for the EpiPen for years and always wondering how much the cost was going to increase, her daughter begged for the Auvi-Q device instead. Made by Kaleo, Auvi-Q is much less bulky, which appealed to the teenager having to carry it.

Kress discovered she was able to get Auvi-Q at practically no cost through a mail-order pharmacy.

“This is like a no-brainer,” Kress said of the effort to increase options for patients.

Size of Mylan contribution unclear

Winders confirmed that her nonprofit accepts donations from Mylan, Kaleo and other manufacturers of epinephrine auto-injectors for “unbranded education and awareness,” but would not say how much.

“Our policy is that we don’t accept more than 15 percent of our overall revenue from any one entity,” she said.

Based on public tax filings, her group brought in $3.2 million in revenue in 2014. Fifteen percent of that is $480,000.

Winders, who has a child with food allergies, strongly objected to any suggestion her group would put money ahead of concern for patients.

“I don’t think I would put my own child at risk for financial support from a pharmaceutical company,” she said.

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Winders said the group doesn’t disagree with the essence of the Ohio bill — reducing patient out-of-pocket expenses is critically important, she said — but she questions whether pharmacists are equipped with the knowledge, training and time to properly explain a differing device to each patient.

“We don’t hear that patients are getting that counseling or education on how to use their EAI device at the pharmacy. That’s usually done by the physician,” she said.

Kelli Barnes, a professor of pharmacy at Ohio State University, testified that Ohio pharmacists are highly trained to provide education when dispensing medications and devices.

“The pharmacist who is dispensing the epinephrine auto-injector will know which device the patient is receiving and will be able to provide the most appropriate education on that device,” she testified.

‘Just a small thing’

Merrin accused Winders’ group and the Food Allergy and Anaphylaxis Connection Team (FAACT), the other nonprofit that has been pushing against the bill, of advocating on behalf of the giant drug company.

“They’re out-of-state interests that are a prop and a puppet for Mylan pharmaceuticals,” Merrin said.

The Allergy and Asthma Network is located in Virginia, but FAACT is located in West Chester. Both groups submitted letters to the House committee that are nearly identical. A call to FAACT’s offices Wednesday was not returned.

FAACT doesn’t hide its ties to Mylan, which is one of its top four sponsors on its website and a sponsor of its annual kids camp, teen retreat and leadership summits.

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A Mylan spokesperson declined to reveal how much the company gives to these groups.

“We have not asked any advocates to act on our behalf or support a specific position for this proposed legislation,” a statement from the company says.

Mylan representatives have met directly with some members of the health committee — including Rep. Jim Butler, R-Oakwood — to express the company’s opposition to the bill.

Butler said provided information about industry prices. He supports the bill as a step toward fighting rising prescription drug prices.

“I think that prices are rising at unsustainable rates,” he said. “This bill is just a small thing that we able to do on this one particular issue.”

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