BILL NUMBER: SJR 29 INTRODUCED
BILL TEXT
INTRODUCED BY Senator Hernandez
(Coauthors: Senators Hall and Leno)
AUGUST 29, 2016
Relative to EpiPen.
LEGISLATIVE COUNSEL'S DIGEST
SJR 29, as introduced, Hernandez. EpiPen: pricing.
This measure would urge the United States Food and Drug
Administration to reconsider its denial of approval for generic
alternatives to the epinephrine auto-injector EpiPen, would urge the
Congress of the United States to investigate the impact that Mylan NV'
s monopoly has had on price increases for EpiPen, and would urge the
Congress and the President of the United States to take action to
limit the unrestrained ability of drug manufacturers to increase
prices based on what the market can bear.
Fiscal committee: no.
WHEREAS, Millions benefit from life-saving drugs and devices,
including Americans with allergies that can be treated by
epinephrine; and
WHEREAS, Last year, doctors wrote 3.6 million prescriptions for
EpiPen, which stops allergic reactions by quickly and safely
injecting epinephrine; and
WHEREAS, In 2007 Mylan NV purchased the rights to EpiPen and
immediately began raising its price. In 2008 and 2009, Mylan raised
the price by 5 percent, and at the end of 2009 it raised the price by
another 19 percent. From 2010 to 2013, Mylan imposed a series of
10-percent price hikes. And from the fourth quarter of 2013 to the
second quarter of 2016, Mylan raised EpiPen prices 15 percent every
other quarter; and
WHEREAS, A pack of two EpiPen devices now has a list price of over
$600, an increase of 548 percent since Mylan began selling the drug,
according to Truven Health Analytics; and
WHEREAS, The formula of EpiPen did not change, and it is no more
effective in protecting against allergic reactions in 2016 than it
was in 2007; and
WHEREAS, During the same time, Mylan began an aggressive marketing
and lobbying effort to increase demand for EpiPen, which included
the passage of federal and state legislation. The United States
Congress passed the School Access to Emergency Epinephrine Act in
2013 to provide an incentive to states to boost the stockpile of
epinephrine at schools. A number of states, including California,
passed laws requiring public schools to have epinephrine. In 2010,
the United States Food and Drug Administration (FDA) changed its
recommendations so that two EpiPen devices be sold in a package
instead of one and that they be prescribed for at-risk patients, not
just those with confirmed allergies; and
WHEREAS, The rising cost of EpiPen has implications for taxpayers.
Over half of California's children are insured through Medi-Cal,
therefore the taxpayers are paying a large share of the cost of this
medication; and
WHEREAS, Mylan has an effective monopoly that it is using to
maximize profit because there is no equivalent generic competitor;
and
WHEREAS, Patients who have to pay retail prices are being forced
to buy EpiPen abroad, where it is cheaper, and are resorting to other
devices that deliver epinephrine, including do-it-yourself syringes;
and
WHEREAS, Even some ambulance providers in California have stopped
the use of EpiPen to treat allergic shock and instead are drawing
from a vial and injecting epinephrine by syringe. First responders in
Seattle have developed such a kit and have sold them to public
health agencies in five other states. There is a demonstration
project in New York called "Check and Inject New York" that trains
first responders to use syringe epinephrine kits in place of EpiPen
to save money; and
WHEREAS, After recent widespread criticism, Mylan said it would
expand access and increase benefits to programs that it uses to help
consumers pay less, but those changes do not alter the prices that
insurers and employers pay. Those institutions will still face the
brunt of the impact from the price hikes; and
WHEREAS, Offering co-payment assistance and free product to
consumers is part of the standard playbook for manufacturers of
expensive drugs. Efforts by drug makers to shield consumers from the
out-of-pocket costs associated with the rapidly increasing cost of
their medications ignores the fact that insurance companies bear the
brunt of these unreasonable price increases, which results in higher
premiums for all consumers; now, therefore, be it
Resolved by the Senate and the Assembly of the State of
California, jointly, That the Legislature declares unnecessary and
unexplained increases in pharmaceutical pricing is a harm to our
health care system that will no longer be tolerated because the
system cannot sustain it; and be it further
Resolved, That the Legislature urges the United States Food and
Drug Administration to reconsider its denial of approval for generic
alternatives to EpiPen; and be it further
Resolved, That the Legislature urges the Congress of the United
States to investigate the impact that Mylan's monopoly has had on the
price hikes for EpiPen; and be it further
Resolved, That the Legislature urges the Congress and President of
the United States to take action to limit the unrestrained ability
of drug manufacturers to increase prices based only on what the
market can bear rather than on providing a fair return on investment;
and be it further
Resolved, That the Secretary of the Senate transmit copies of this
resolution to the President and Vice President of the United States,
to the Speaker of the House of Representatives, to the Majority
Leader of the Senate, to each Senator and Representative from
California in the Congress of the United States, to the Secretary of
the United States Department of Health and Human Services, and to the
Commissioner of Food and Drugs, and to the author for appropriate
distribution.