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EpiPen, Dey, Inc.

Dey, L.P., an affiliate of Merck KGaA, is a specialty pharmaceutical company focused on the development, manufacturing and marketing of prescription drug products for the treatment of respiratory diseases (such as Chronic Obstructive Pulmonary Disease (COPD) and Asthma) and respiratory related allergies (such as Anaphylaxis.)

Situation:

  • Dey, L.P. wanted to assure that California school children with known severe allergies and prescriptions for auto-injectable epinephrine had the ability to carry and self-administer auto-injectable epinephrine in order to respond to potentially deadly allergic reactions in time.

Challenges:

  • As a result of zero tolerance drug policies and the absence of a state law governing a child’s right to carry and self-administer medications, some school districts kept all medications locked in the school office, and a child’s ability to quickly access emergency medication was dependent on the school district in which he or she happened to reside.
  • Client’s perceived self-interest precluded it from being a good sponsor for legislation.
  • Because McCallum Group was not hired until April, long after the deadline for introducing bills, we also had to identify an existing bill which could be used as the vehicle for our “gut and amend” bill language.

Solution/Outcomes:

  • The Governor signed SB 1912, which authorizes a pupil to carry and self-administer auto-injectable epinephrine, and the related bill, AB 2132, which authorizes a pupil to carry and self-administer inhaled asthma medication.
  • As a result of McCallum Group’s work on SB 1912, McCallum Group was hired by West Coast Asthma and Allergy Network (WestCAAN), after bill introduction deadlines had passed, to provide consulting and advocacy services relating to that group’s vision of better protecting pupils and staff experiencing life-threatening symptoms of anaphylaxis or asthma at school or a school activity by training staff to administer emergency aid, and providing emergency medications to each school site.
  • McCallum Group crafted bill language and secured an author for “gut and amend” legislation. Although WeCAAN ultimately elected to drop the 2006 legislation, McCallum Group’s introduction of the bill caused the California Department of Education to convene a workgroup, including WeCAAN’s designee, to come up with a state policy and procedures in this area.

Process:

  • Identified and brought together potential supporters, one of which decided to sponsor legislation to address the need.
  • By making Capitol inquiries, McCallum Group identified a staff member who carried an EpiPen, and the staff member’s boss ultimately agreed to carry legislation.
  • McCallum Group drafted bill language, a fact sheet on the legislation, and committee worksheets for the bill.
  • McCallum Group garnered bill supporters including the California Federation of Teachers, California Medical Association, California School Nurses Association, California State PTA, and California Teachers Association.
  • McCallum Group reviewed research documenting the life-saving benefits of quickly administering epinephrine to children and adolescents and the number of California children with severe food allergies who would potentially benefit from the legislation, and used this data in meetings with and letters to Legislators and the Governor.
  • SB 1912 was double joined with a bill authorizing pupils to carry and self-administer asthma medication; McCallum Group advised author’s office of amendments needed to assure passage of the asthma bill.
  • McCallum Group worked with the California Department of Education, Department of Health Services, and bill supporters to craft acceptable compromise language to address Departments’ concern about sharing or misuse of medication.
  • McCallum Group advised the Governor’s staff of federal legislation that would give a preference, in awarding grants, to states that require schools to allow students to self administer medication to treat the student’s asthma or anaphylaxis, as part of McCallum Group’s advocacy to convince the Governor to sign the legislation.
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