ENA Government Affairs Update
September 15, 2018
ENA Government Relations
FDA Approves First Generic Version of Popular EpiPen
The U.S. Food and Drug Administration (FDA) has approved the first generic competitor to EpiPen and EpiPen Jr. for the emergency treatment of allergic reactions in adults and children. In mid-August, Teva Pharmaceuticals USA gained FDA approval to market its generic epinephrine auto-injector for adults and pediatric patients who weigh more than 33 pounds.
"This approval means patients living with severe allergies who require constant access to life-saving epinephrine should have a lower-cost option, as well as another approved product to help protect against potential drug shortages," FDA Commissioner Scott Gottlieb, MD, said in a statement. The approval stems from the FDA's Drug Competition Action Plan, announced last year. "We're especially committed to the development of generic copies of complex products," Gottlieb said. "These products can be hard to copy, and therefore sometimes don't face timely generic competition once patents and exclusivities are no longer a block to approval." No timeline for releasing the generic auto-injectors was announced. More than 3.5 million Americans received a prescription for EpiPen in 2015.
Newly-Introduced Bill Continues Emergency Medical Program for Kids
Emergencies can strike without warning, in any location, at any time. It is imperative that hospitals and emergency departments are appropriately equipped to provide the best care possible for their most vulnerable patients - children. For more than 30 years, the Emergency Medical Services for Children (EMSC) has been the only federal program whose function it is to enhance the ability of the nation's hospitals to provide emergency care for pediatric patients. EMSC, operated by the Health Resources and Services Administration (HRSA), provides funds to all states, the District of Columbia and U.S. territories for hospitals and emergency department to purchase and maintain equipment, supplies and medication needed to provide care for children and adolescents during an emergency.
On September 7, Rep. Peter King (R-NY) introduced the Emergency Medical Services for Children Program Reauthorization Act of 2018 (HR. 6748), which would extend the EMSC program for an additional 5 years, through 2024. The bipartisan bill also authorizes the program at $22.33 million dollars per year during that period, equal to funding provided in 2018.
2018 Voters: Health Care is our Top Concern
Healthcare is solidifying as the number one issue on voters' minds as they head to the voting booths in November. A June poll of registered voters by NBC News and The Wall Street Journal (NBC/WSJ) showed voters rating healthcare as their top issue going into the elections. That poll echoed a Kaiser Family Foundation poll, also released in June. The Kaiser survey found healthcare to be a top issue for Democratic and independent voters but a second-tier issue for Republican voters. Still, about 25% of all those surveyed rated healthcare as their number one issue in the Kaiser poll. (Twenty-two percent rated it number one in the NBC/WSJ poll.)
Beyond identifying healthcare as their number one issue, very few voters in the Kaiser poll could or would drill down on a single position that would sway their vote. However, for those who did respond to a list of alternative positions, "majorities of Democratic voters, independent voters, and Republican voters say a candidate's support for continued protections for people with pre-existing health conditions" as a significant factor to their voting decision.
Illinois Governor Approves Bill to Improve Care for Sexual Assault Survivors
On Aug. 10, Gov. Bruce Rauner signed into law HB 5245, which increases the number of sexual assault nurse examiners in the state, including those who are specially trained to treat child victims of sexual assault. Illinois ENA members worked to pass the bill, aligning its support with the Illinois Attorney General's Office; raising the issue of sexual assault care during town hall sessions with legislators; and contacting the governor's office urging him to sign the bill. The bill quickly moved through the legislature, with members voting unanimously to enact the bill. Hospitals have until 2022 to comply with the new requirements for ensuring an appropriate number of staff receive the specialized training.
National Academies to Develop New Opioid Prescription Guidelines
The FDA has awarded a contract to the National Academies of Sciences, Engineering, and Medicine (NASEM) to help develop evidence-based guidelines for prescribing appropriate opioid analgesics for acute pain. The goal is to understand what evidence is necessary to ensure all current and future clinical practice guidelines for prescribing opioid analgesics are sufficient and what research is needed to generate that evidence in a practical and feasible manner.
"Our analyses suggest that the first prescription for many common, acute indications could typically be for many fewer pills - maybe just a day or two of medication rather than a 30-day supply, which is typically prescribed," the FDA stated in an Aug. 22 press release. "In some cases, the excess pills that aren't used by patients may end up being diverted to illicit markets or misused or abused by friends or family members. In other cases, patients who are prescribed more medication than necessary may find themselves at increased risks for misuse, abuse, and addiction."
Federal Advocacy Update: ENA Priority Legislation
Here you will find monthly updates on the status of bills that are of priority concern or focus for ENA. We will utilize this section to provide basic information such as new cosponsors that have signed on in the last month or updates on the status of the bill's movement through Congress. When bills are first added, existing cosponsors will be listed. Following, you will see only new cosponsors listed monthly. You may review the legislation and a complete list of cosponsors by clicking the link provided.
Health Care Workplace Violence Prevention Act
Sponsor: Rep. Khanna, Ro [D-CA]
No new cosponsors since August 10, 2018
Status: This bill currently awaits action in the House Energy & Commerce, Education & Workforce, and Ways & Means Committees
MISSION ZERO Act
Sponsor: Rep. Burgess, Michael [R-TX]
Status: This bill was passed in the House of Representatives on February 26, 2018 by voice vote.
Sponsor: Sen. Isakson, Johnny [R-GA]
Status: A modified version of MISSION ZERO was approved by the HELP Committee as part of reauthorization of the Pandemic and All-Hazards Preparedness Act reauthorization bill on May 23, 2018.
Stop, Observe, Ask, Respond (SOAR) to Health and Wellness Act
Sponsor: Rep. Cohen, Steve [D-TN]
No new cosponsors since September 13, 2017
Status: This bill was passed in the House of Representatives on February 26, 2018 by voice vote
Sponsor: Sen. Heitkamp, Heidi [D-ND]
No new cosponsors since June 12, 2018
Status: This bill awaits action by the Senate HELP Committee
Air Ambulance Quality and Accountability Act
Sponsor: Rep. Hudson, Richard [R-NC]
New Cosponsors Party/State/Dist. Date Added
Rep. Meadows, Mark [R-NC-11] 9/12/2018
Status: This bill currently awaits action by the House Energy & Commerce and Ways & Means Committees
Senate: Please note there is currently no Senate companion for H.R. 3780
Good Samaritan Health Professionals Act
Sponsor: Rep. Blackburn, Marsha [R-TN]
New Cosponsors Party/State/Dist. Date Added
Rep. Moulton, Seth [D-MA-6] 8/24/2018
Status: Passed by House Energy & Commerce Committee on February 14, 2018
A version of Good Sam was included in a bill to reauthorize PAHPA programs that was approved by Energy & Commerce on July 18, 2018.
This bill awais action by the House of Representatives
Sponsor: Sen. Cassidy, Bill [R-LA]
No new cosponsors since July 25, 2018
Status: This bill currently awaits action by the Senate HELP Committee