When Mylan’s EpiPen pricing scandal broke, the company was criticized for lobbying for legislation that would require schools to carry epinephrine injectors, a market dominated by its product. In response, the drugmaker defended itself by pointing out that it has donated hundreds of thousands of injectors free to schools through a special giveaway program, a program that has been credited with saving thousands of children’s lives. So what is the EpiPen4Schools program?
FiercePharma found out by speaking with Bob Anderson, CFO of BioRidge Pharma, which handles the fulfillment of the program for Mylan. BioRidge has distributed 700,000 EpiPens--or 350,000 twin-packs--to schools for free in the last four years. The program is on track this year to distribute an additional 150,000 twin-packs, Anderson estimated. That’s an increase over the more than 100,000 twin-packs distributed last year.
Whether that increase is tied to the controversy surrounding the product, Anderson doesn’t know. “There’s been an uptick just because the timing right now which is back to school. All of the repeat customers generally get them every year and as more schools find out, they request them too. I don’t know whether you can attribute that to what’s going on in the news,” he said.
But Anderson is confident there is ample evidence that the program works. When schools use the pens on children and request free replacements, the EpiPen4Schools website asks that they fill out a form providing details about the incident. He estimates at least 100 incident forms are filled out every month.
“Literally thousands of kids’ lives have been saved--and those are the ones that we know of,” Anderson said of the school-provided feedback.
Through the program, all K-12 schools in the country can apply to receive four auto-injectors, or two twin-pack sets, every year at no cost. School districts can apply on one application for allotted free EpiPens for each of its individual schools. If a school has to use a set of EpiPens on a child during the year, that pack will be replaced also at no cost, Anderson said.
BioRidge has sent the auto-injectors to some 60,000 schools in every state and is managing state laws along the way. Some states, for instance, allow standing orders of epinephrine for emergency use in schools. In Illinois, as a specific example, prescriptions for EpiPen can be written without an end user’s name. Other states, such as Texas, however, require a specific patient’s name on the prescription. In that case, BioPharma distributes to a prescribing doctor who places it under their care at the school, Anderson said.
BioRidge is affiliated with specialty pharma services company Asembia Health Care, which recently changed its name from Armada Health Care. The two have the same ownership group. BioRidge is paid a fee for its fulfillment work but says the revenue from the Mylan EpiPen4Schools program is less than 1% of its total. Its main business is buying, selling and distributing pharmaceutical products to pharmacies.
All states, except Hawaii, have laws or guidelines that allow schools to keep EpiPens on hand for emergency use, and 11 states require schools to do so, according to data from the Food Allergy Research & Education association. In November 2013, federal legislation called the School Access to Emergency Epinephrine Act was signed into law and provides financial incentive in the form of preference for “awarding certain asthma-related grants” to states that enact their own laws requiring schools to keep epinephrine injectors on hand.
Mylan has been criticized for pushing for the legislation, and paying lobbyists and donating to political campaigns, because while the laws do not specify that schools carry the EpiPen brand, Mylan has a dominant market share and there are few alternatives.
But now many politicians have turned on the drugmaker for having pushed up the price of the product by more than 400% since 2009 to more than $600 for two. Among those, Sen. Amy Klobuchar (D-MN) has called for the Senate Judiciary Committee and Federal Trade Commission to investigate the pricing practices while Sen. Chuck Grassley (R-IA) is seeking info on the topic. Today, Democratic Presidential nominee Hilary Clinton cited Mylan’s price hikes as one reason for her proposal to set up a drug price oversight panel that would take action when prices have risen significantly.
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