By Senator Chuck Grassley
Back to school shopping this year brought sticker shock for
families in Iowa and elsewhere. This wasn’t over pencils and notebooks but a
life-saving device that kids with severe allergies have to have available at
all times. The EpiPen cost has jumped more than 400 percent since 2007.
Paying
as much as $600 per product is a lot of money, especially considering families
like one in Polk City, Iowa, with four kids who need EpiPens.
The shelf life is
about a year, so the EpiPen needs to be replaced, and parents try to stock the
item in multiple places, like grandma’s house, in case of emergency.
The price increases brought scrutiny on the company, Mylan,
that sells EpiPens. Iowans asked me to find out what was going on, and I
started asking questions.
Soon afterward, Mylan announced steps to help
patients afford the product: more patient discount coupons and an authorized
generic version. Still, the company won’t lower the price, and daily headlines
tell us the EpiPen is only one of many prescription medicines busting budgets.
So what can and should be done to hold down drug costs?
One of the best ways is to increase competition, where drug
companies are encouraged to innovate and produce new products and the
marketplace works to drive down prices.
Driving down prices also requires
making sure drug companies are playing fair and not gaming the rules. The
Department of Justice and the Federal Trade Commission enforce the antitrust
laws and investigate anti-competitive behavior.
Companies aren’t allowed to
engage in unfair or deceptive practices that end up harming consumers. The
agencies need to be assertive in enforcing these laws.
I’m a co-sponsor of two bipartisan bills that would help
address drug company practices that have delayed the availability of generic
drugs and kept drug costs high for patients. One is the Creating and Restoring
Equal Access to Equivalent Samples (CREATES) Act.
This bill would deter brand
name pharmaceutical companies from blocking less expensive generic alternatives
from entering the market. The brand companies do this by denying access to the
drug samples that generic makers need to develop their generic versions.
The
second bill is the Preserve Access to Affordable Generics Act. It would help
end the practice of brand name and generic manufacturers’ using anti-competitive
pay-off agreements to keep more affordable generic equivalents off the market.
Another way to lower costs is making sure drug companies
aren’t gaming taxpayer-funded public health care programs. Medicare and
Medicaid are big customers for prescription drugs and medical devices.
When
they overpay, the taxpayers overpay, and so do the beneficiaries who face out
of pocket copayments. My office found that Mylan relies heavily on Medicare and
Medicaid for its EpiPen revenue. Meanwhile, the federal agency that runs those
health care programs says Mylan has been overcharging Medicaid for EpiPens.
This might have cost the taxpayers hundreds of millions of dollars. Where was
the federal agency while this was going on?
The taxpayers are getting short
shrift, and the Obama Administration has not done its job here. I’m continuing
to ask questions. The Justice Department, and other agencies, now seem to be
paying attention.
Yet another way to drive down drug costs is the reimportation
of prescription drugs from other countries where product safety and
effectiveness can be assured.
The Food and Drug Administration already has the
power to certify the safety of such drugs. The agency hasn’t wanted to use this
power for reasons that are unclear.
The FDA also needs to continue to make progress on its backlog
of generic drug applications. When a company has submitted an application for a
generic product, consumers deserve a timely answer on whether that product is
ready for the marketplace.
And while the FDA’s no. 1 job is protecting public
safety, the agency also needs to make sure not to impose unneeded regulations
that prevent patients from getting new alterative or generic drugs as soon as
possible.
There may be other steps that would ease the sticker shock of
sky-high prescription drug prices. In the meantime, I’m working on legislation
and oversight efforts that will make a big difference for consumers and the
people of Iowa.
