Senator Kirk: Allergic Reactions Can Be Deadly; Families Need Affordable Treatment

Kirk: Allergic Reactions Can Be Deadly; Families Need Affordable Treatment

WASHINGTON –(ENEWSPF)–September 2, 2016.  U.S. Senator Mark Kirk (R-Ill.) today sent a letter to Food and Drug Administration (FDA) Commissioner Dr. Robert M. Califf following recent reports of skyrocketing epinephrine injection prices. Senator Kirk is calling on the FDA to use their authority to approve alternatives to Mylan’s EpiPen so that epinephrine is readily available for those who need it.

“Access to emergency life-saving medical treatment should not be left to chance in America,” said Senator Kirk. “The recent approval of nasal naloxone is a great model of the agency working expeditiously to identify solutions for current medical need. I hope the agency will apply a similar approval model to quickly improve access to epinephrine.”

The full text of the letter is included below:

Dr. Robert M. Califf
Commissioner
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD  20993

Dear Commissioner Califf

Access to emergency life-saving medical treatment should not be left to chance in America.  Unfortunately, recent media reports have indicated that a recent increase in the price of a specific form of epinephrine injection indicated for use in emergency treatment of allergic reactions, including anaphylaxis, Mylan’s EpiPen®, (NDA 019430) represents a potential barrier to access for vulnerable populations, including students in the classroom and low-income individuals.  As such, I write to inquire as to the measures FDA is taking to strike a balance between establishing a high standard of safety and efficacy of medical treatments, and increasing the availability of those treatments, including by making new epinephrine products eligible for market as an Over-the-Counter (OTC) product.

As you may know, I have long advocated for increased access to emergency epinephrine auto-injectors, including provisions enacted under P.L. 113-48, the School Access to Emergency Epinephrine Act. This statute incentivizes states to ensure schools maintain an accessible supply of the lifesaving medication, and the personnel to administer it. As a stroke survivor, when it comes to medical emergencies, I know that every minute counts, and any mother or father should be able to stockpile enough to be prepared if their son or daughter suffers from anaphylactic shock. That is why I am particularly concerned that the lack of access to the EpiPen® may result in delayed or denied treatment for individuals in the middle of a life-threatening allergic event.  While many states like Illinois have taken steps to expand access to epinephrine treatments by training first responders in more complex forms of administration, the auto-injector remains the industry standard.

While I recognize the need for rigorous FDA evaluation of drug and medical device applications, it would be equally irresponsible for your agency to protect the marketing rights of a private company at the expense of patient safety.  Therefore, I would like to know what FDA views as the current challenges posed by Mylan’s decision to raise the price of the EpiPen® and what measures are being taken to mitigate the impact of this decision.

1. Some have suggested that the EpiPen should be available OTC. What is FDA’s position on OTC EpiPen?  Does the EpiPen warrant unique consideration?
2. What plans does FDA have to ensure that first responders and school faculty have access to appropriate training and/or are protected from liability in the event they are forced to use traditional epinephrine as opposed to an auto-injector?
3. FDA has many tools at its disposal, particularly in the wake of the Drug Quality and Security Act (DQSA), which contained many provisions intended to address shortages.  Does Mylan’s decision pose the threat of a shortage?  If so, does FDA need additional authorities to prevent a shortage of epinephrine?

The recent approval of nasal naloxone is a great model of the agency working expeditiously to identify solutions for current medical need. I hope the agency will consider this approval model if access to epinephrine worsens.

If you have any questions, please contact my office at (202) 224 8254.

Sincerely,

Mark Kirk
United States Senator

Source: http://kirk.senate.gov