FARE Letter to FDA

Scott Gottlieb, M.D.

Commissioner of Food and Drugs

U.S. Food and Drug Administration

5630 Fishers Lane, Rm. 1061

Rockville, MD 20852

Email: CommissionerFDA@fda.hhs.gov

Dear Dr. Gottlieb:

On behalf of the 15 million Americans with potentially life-threatening food allergies, Food Allergy Research & Education (FARE) writes to express our concern with the reported lack of availability for epinephrine auto-injectors, sold under the brand names EpiPen^®, EpiPen 2-Pack^®, EpiPen Jr.^®, EpiPen Jr. 2-Pack^®, and as authorized generics, by Mylan, Inc. The product is made by a subsidiary of Pfizer, Inc., and distributed by Mylan.

FARE appreciates FDA’s press statement yesterday referring to a “spot shortage” in some parts of the United States^[1]. We note, however, that FDA has not declared the “spot shortage” in any official publications, as it does not appear on the Drug Shortages page of the FDA website^[2] or in a press release or blog post. This lack of public recognition by the federal government is troubling, particularly given the FDA’s public health mission.

A National Shortage?

FDA representatives stated April 30 that “this is not a national shortage,” but FARE’s monitoring indicates that there may well be a shortage, not just in the United States, but internationally as well. Importantly, FARE is concerned that the two companies, Mylan and Pfizer, have not provided clarity on supply issues surrounding this life-saving medication to patients at risk of anaphylaxis.Patients are unwilling to wait any longer.

As both companies are domiciled in the U.S., we believe the FDA is uniquely positioned to ensure dialogue among the two manufacturers and, if needed, their upstream suppliers and downstream distributors. FARE urges FDA to use all available legal remedies to ensure that all patients across the country have access to epinephrine auto-injectors.

FARE has been monitoring this issue for some time, with growing concern. Epinephrine auto-injectors have recently been reported as in shortage in both Canada and the United Kingdom.

In mid-April, FARE began receiving inquiries regarding the risk of a shortage in the United States.^[3] Representatives from Mylan and Pfizer have responded that product is being shipped and that local supplies may vary.

In addition to hearing from constituents, FARE has closely monitored media reports. On Tuesday, April 24, FARE learned of low stocks of the 0.3 mg dose at Wegmans grocery stores in five states.^[4] By last Friday, April 27, the anecdotal reports of shortages had expanded to ten states and to additional pharmacies, including some Walgreens CVS, Rite Aid and Costco stores.^[5] As of yesterday, there are reportedly concerns about epinephrine access in at least 14 states (NY, NJ, IL, TX, OH, VA, MD, MA, AE, KY, GA, TX, CA, WA).^[6]

“Spot Shortage” Declared

On April 30, an FDA representative stated that the Mylan / Pfizer products are in a “spot shortage” in some parts of the US.^[7] However, we understand that FDA depends upon reporting that is required of the manufacturer. FARE has requested additional information from both Mylan and Pfizer, including greater transparency as to the nature of the problem, how each company is addressing it, and a timeline for additional supplies to become available. Patient advocates are also concerned about reports of quality problems^[8] and the availability of product in time for back-to-school this fall.

FDA can help to bridge the divide between the two companies, and FARE calls upon the agency to act with all deliberate speed to investigate further.

Alternatives for Patients

In response to the reports about the Mylan / Pfizer product, FARE released a statement to Allergic Livingrecommending that patients speak to their physicians about getting a prescription for a different auto-injector, as there are other FDA-approved epinephrine auto-injectors, manufactured by Kaleo (Auvi-Q) and Impax Therapeutics (authorized generic of Adrenaclick).

FARE has further advised that patients who are experiencing any delay in filling a prescription for EpiPen should talk to their physician about ensuring that they can have a prescription filled promptly and there is no interruption in the accessibility of this medication. In absence of a current epinephrine auto-injector, patients may use an expired dose but should call 911 and receive medical treatment.

While we recognize that FDA is unable to make similar recommendations that could be construed as medical advice, it would be helpful if the agency could refer patients to reputable organizations, such as FARE, for more information.

On behalf of the 15 million Americans with potentially life-threatening food allergies, we appreciate your attention to this matter. Thank you.

Sincerely,

James R. Baker, M.D.
Chief Executive Officer and Chief Medical Officer

^[1]Matti, M. “U.S. EpiPen Supply Shortage a “Spot Shortage,” says FDA.” Allergic Living, April 30, 2018. Available at: https://www.allergicliving.com/2018/04/30/u-s-epipen-supply-issue-a-spot-shortage-says-fda/.

^[2]FDA Drug Shortages, accessed May 1, 2018, available at: https://www.accessdata.fda.gov/scripts/drugshortages/default.cfm

^[3]Berkrot, B. “EpiPen shortages seen in Canada, UK but U.S. supply intact.” April 13, 2018. Available at: https://www.reuters.com/article/us-mylan-nl-pfizer-epipen/epipen-shortages-seen-in-canada-uk-but-u-s-supply-intact-idUSKBN1HK2YG.

^[4]Matti, M. “EpiPen Supply Issues Reported in Some U.S. Regions.” Allergic Living, April 24, 2018. Available at: https://www.allergicliving.com/2018/04/24/epipen-supply-issues-reported-in-some-u-s-regions/.

^[5]Matti, M. “U.S. Consumers Report EpiPen Supply Issues: What to Do and Auto-Injector Choices.” Allergic Living, April 27, 2018. Available at: https://www.allergicliving.com/2018/04/27/u-s-consumers-report-epipen-supply-issues-what-to-do-and-auto-injector-choices/

^[6]Matti, M. “U.S. EpiPen Supply Shortage a “Spot Shortage,” says FDA.” Allergic Living, April 30, 2018. Available at: https://www.allergicliving.com/2018/04/30/u-s-epipen-supply-issue-a-spot-shortage-says-fda/.

^[7]Ibid.

^[8]Bloom, D., Snack Safely. https://snacksafely.com/2018/04/a-call-to-pfizer-come-clean-on-epipen-shortage-and-manufacturing-issues/