Mylan, Allergy Advocates Unite Congress for School Drive

A lobbying effort by drugmaker Mylan Inc. and others for schools to stock products that treat severe allergic reactions, like the company’s popular EpiPen, has accomplished something rare in Washington: uniting Congress.

White House officials said President Barack Obama will sign the bill, cleared by the Senate last week, which encourages states to have schools buy and store the life-saving allergy drugs.

At least three companies including Mylan of Canonsburg, Pennsylvania, make devices to deliver the drug epinephrine. Mylan estimates gaining access to schools could help expand its customer base to as many as 28 million from 2.6 million now.

The Republican-led House and the Democratic-led Senate both have passed few of the same bills, with just 47 measures signed into law this year -- the first of Obama’s second term. At this point in 2005, the first year of President George W. Bush’s second term, 284 bills had become law, records show.

“We don’t agree most days on whether the sun comes up in the east,” said Republican Representative Phil Roe, an obstetrician from Tennessee sponsoring the bill. “On this, we put all those things away and worked on what we agreed on.”

An estimated 3.9 percent of U.S. children, or about 3 million younger than 18, had food allergies in 2007, according to a 2009 report by the U.S. Centers for Disease Control and Prevention. That’s up from 3.3 percent a decade earlier.

No History

About one-fourth of anaphylactic reactions, which causes swelling that can obstruct airways and lead to death, occurred in children with no history of life-threatening allergies, according to a 2005 study published in Pediatrics journal.

Four states already require public schools to stock epinephrine: Maryland, Nebraska, Nevada and Virginia, according to statistics from Food Allergy Research & Education, a Washington-based group that advocates for Americans with food allergies and the key lobbyist on the allergy bill. Virginia’s law passed last year following the death of 7-year-old Ammaria Johnson, a first grader, who had a severe reaction after eating a peanut at recess.

The clinic in Ammarias’s elementary school had EpiPens prescribed for other children. None, by law, were allowed to be used for her, even in an emergency.

The measure is designed to encourage other states to follow suit. The School Access to Emergency Epinephrine Act gives states priority for asthma-related federal grants if schools maintain a supply of epinephrine, and train employees to administer the drug in an emergency. The bill also provides civil-liability protection for those who administer epinephrine in an emergency.

‘Emotional Components’

“The insidious thing about food allergies is it’s not just only the physical components of it, it’s the emotional components,” FARE Chief Executive Officer John Lehr said in an interview. “You can imagine a family with children with multiple allergies and just the fear they live with that something so ubiquitous -- food -- can potentially kill you.”

Lehr’s organization has pushed for the bill for three years, as has Mylan, which is the group’s top corporate sponsor and has an 88 percent share of anaphylaxis drug sales in the U.S., according to a Bloomberg Industries report. Two other companies that make epinephrine auto-injectors -- Sanofi of Paris and Horsham, Pennsylvania-based Amedra Pharmaceuticals LLC -- also contribute to the group, Lehr said.

$600 Million

Auto-injectors for epinephrine is a $600 million market, Hanspeter Spek, president of global operations for Sanofi, France’s biggest drugmaker, said during an investor call on Oct. 25, 2012. Before Sanofi in January introduced its Auvi-Q device, which gives audio and visual cues to help patients and care-givers make the injection, Mylan had 95 percent of the market with its EpiPen, Spek said.

An EpiPen is about the size of a Sharpie marker and contains a single dose of epinephrine, which is injected into the thigh.

Mylan, the second-biggest generic drug-maker by sales, has sold 51 million EpiPens in 25 years, including 3 million last year, Roger Graham, president of Mylan Specialty LP, the unit that makes EpiPen, said during an Aug. 1 teleconference.

“Mylan is fully supportive of the state and federal legislative activities that will expand access to epinephrine in schools, because even one incident without access to epinephrine is one too many,” Nina Devlin, Mylan vice president of corporate communications, said in a statement.

20,000 Schools

To raise awareness, the company last year started giving away EpiPens to schools that request the devices. Graham said 20,000 schools sought the product this year. He added that EpiPen had 2.6 million customers and the potential for 28 million.

Mylan’s awareness campaign includes Adrian Peterson, a running back for the National Football League’s Minnesota Vikings whose used an EpiPen when his throat swelled shut after eating shrimp gumbo in 2011.

Earlier this year, the company was tracking legislation in 26 states to encourage or require schools to stock epinephrine, Heather Bresch, Mylan’s chief executive officer, said during a May 2 earnings call.

“We remain confident that it’s only a matter of time until the rest of the states follow suit,” she said.

Academies’ Backing

The company has employed at least four lobbyists on the issue since 2011, while Sanofi has hired 10, according to lobbyist registration data. FARE lined up support from the American Academy of Pediatrics, the American Academy of Allergy, Asthma, and Immunology, and the American College of Emergency Physicians.

“We did our homework and got everybody lined up behind it,” Lehr said.

Lehr’s group, which worked on the issue for three years, also enlisted Brianna Adkins, the daughter of country music singer Trace Adkins, who performed at the 2012 Republican National Convention in Tampa, Florida. Roe said Brianna Adkins, a fellow Tennessean, visited his Washington office to ask him to sponsor the bill.

“Probably the best lobbyist I’ve talked to since I’ve been in Washington, this 12-year-old,” Roe said. “She made a great point about how children can die.”

The bill had bipartisan support, with House Minority Whip Steny Hoyer, a Maryland Democrat, helping Roe to push the bill. Hoyer said his granddaughter has severe food allergies and has been hospitalized because of allergic reactions.

Hoyer said liability issues stalled the bill last year. This year, lawmakers worked through that issue because the measure “will save lives.”

“The only way we’ve accomplished things is to act in a bipartisan way,” Hoyer said in an interview. “In this case, we had overwhelming support from both sides.”

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