Future of New York State Generic Epi Bill Uncertain

Future of New York State Generic Epi Bill Uncertain

Sometimes it takes a while for a few of our New York State legislators to “get it” when it comes to voting for issues related to allergies and how to better protect the public. But we do have many strong supporters who never give up trying. Senator Kemp Hannon and Assemblyman Tom Abinanti proposed a bill that would authorize a pharmacist to substitute an alternate epinephrine auto-injector (EAI) device containing the same active ingredients, under certain conditions. The bill got stuck in the assembly higher education committee, saying it was "held for consideration.” Don’t worry, we never give up either, and it would be wonderful if you could contact your legislator to voice your support.

Left to R: Jon Terry, Jennifer Jobrack, Senator Kemp Hannon, Kirsi Jarvinen-Seppo MD, AM Tom Abinanti.
L-R: Jon Terry, Jennifer Jobrack, Senator Kemp Hannon, Kirsi Jarvinen-Seppo MD, AM Tom Abinanti.

Progress of Hannon-Abinanti bill has been stopped for now

By Jon Terry
June 15th, 2018

Greetings. Since our Food Allergy Awareness Day ended on May 16th, important developments have taken place in Albany. The Allergy Advocacy Association's campaign to obtain passage for a new generic epinephrine law has reached a disappointing but not surprising conclusion for this year.

Concerning New York State bill A7219/S289 sponsored by Senator Kemp Hannon and Assembly Member Tom Abinanti, their legislation has been effectively halted. NYS Assembly Member Deborah Glick, chairman of the assembly higher education committee where A7219 was being reviewed, has "held the bill for consideration." One reason for the hold may be opposition against the bill from certain companies in the pharmaceutical industry.

The Hannon-Abinanti bill would authorize a pharmacist to substitute an alternate epinephrine auto-injector (EAI) device containing the same active ingredients, where: (1) the prescriber does not indicate that the prescription must be dispensed as written; (2) the alternate epinephrine auto-injector available would cost less; and (3) the patient consents.

In his request for sponsorship support from other assembly members, Mr. Abinanti emphasized that "… while the existing New York generic substitution law permits pharmacists to dispense a lower cost generic drug for a brand name prescription drug unless the prescriber writes 'dispense as written', questions have arisen about whether the current law covers epinephrine auto-injectors which are a combination drug and a device for administering the drug or whether an alternate brand name injector may be substituted where the prescribed injector is not available. The bill provides better consumer choice."

Our association whole-heartedly agrees with Tom's assertion: new legislation is definitely needed to clarify the prescribing authority for EAI devices. Without a new law, confusion and disinformation will deter consumers with life-threatening allergies from purchasing life-saving epinephrine at more affordable prices.

Members of Ms. Glick's staff, who did not wish to be quoted directly, have indicated that "… since the alternative epinephrine auto injectors have a different administration and mechanism they did not believe it was appropriate to allow for a substitute as it might endanger individuals that needed this life saving medication."

It is true that some generic devices operate differently than current EAI devices already on the market; they more closely resemble a syringe and have a needle that is exposed throughout the injection process. However, once you are familiar with them, the generic devices are very easy to use. Indeed, simple visual operating instructions are clearly labeled on each and every device.

Another important factor is the continuing development of new EAI devices by generic brand pharmaceutical companies; a couple of new injectors may be available this year. And still more are in the pipe line heading towards the consumer market. Competition within the EAI device marketplace is bound to help reduce the exorbitant expense of epinephrine in America. An educational component somewhere in the prescribing and selling process may help all concerned parties.

An amended bill might include text requiring the pharmacist to demonstrate and train all customers on proper usage of generic EAI devices in an anaphylaxis emergency.  The text might read something along these lines.

The pharmacist must demonstrate the operating features of the alternate epinephrine auto-injector to the purchaser and train them on proper usage of the alternate epinephrine auto-injector in an anaphylaxis emergency.

Tom and Kemp's bill has over 30 co-sponsors in the assembly and seven in the senate. The last day of the 2018 New York State legislature session is June 20th. All legislation not enacted by the end of this session must be re-submitted next January 2019 after the November elections.

The Allergy Advocacy Association believes that failure to act on generic legislation by our lawmakers places the interests of pharmaceutical companies ahead of patients with a potentially fatal allergy. Countering the enormous cost of EAI devices through prudent government action must be a priority for all leaders and lawmakers inside and outside of our state. Our association continues to support legislation that improves access to life-saving epinephrine to all consumers. We remain committed to making generic brands easily available as a means of reducing the costs of all medications across our country.

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