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The dangers of Clinton’s prescription drug plan
By Joel M. Zinberg of CEI.
“Hillary Clinton’s Plan for Lowering Prescription Drug Costs” — a
campaign briefing — is a blueprint for destroying our pharmaceutical
industry. And it isn’t just drug companies that should be scared. The
plan sets a precedent for destructive command and control in every part
of the economy.
Citing ACA provisions that limit health insurance companies’ margins
as a model, Clinton claims that because drug companies benefit from
federally funded research and R&D incentives, they should not be
allowed to reap “excessive profits” or spend “unreasonable amounts” on
marketing, and should be required “to invest a sufficient amount” in
R&D. I have no idea what level of drug company profits is
“excessive,” what is “reasonable” to spend on marketing, or what is
“sufficient” R&D investment. But I doubt government bureaucrats do
either.
Two Clinton proposals — the importation of drugs from overseas and
Medicare negotiation of drug prices — amount to price controls that will
lower prices in the short-run but destroy drug development in the
long-run, resulting in fewer choices for physicians and patients. Many
countries’ governments set drug prices and ration coverage either by
being the sole large drug purchaser or through regulation. Importing
these countries’ cheaper drugs imports the shortcomings of their price
control regimes.
Allowing Medicare, as Clinton describes it, to “use its
leverage [to] drive down drug and biologic prices” would be more akin
to the government price setting that occurs overseas, rather than a
negotiation. The over 55 million Medicare beneficiaries are older and
sicker than the rest of the population and consume a disproportionate
amount of all drugs used. As a result, Medicare would effectively
dictate drug prices nationwide and decree which drugs would be
available.
While companies benefit from federally financed discoveries, turning
those findings into usable drugs is an expensive and risky private
enterprise. Only one out of thousands of investigational compounds
advances through the stages of R&D, preclinical animal testing and
three phases of human clinical trials to become a marketed drug. The
average cost to market per new drug is $2.6 billion. Only one in three
is profitable and only one in ten becomes a blockbuster. Without
temporary high prices in the U.S. market before generic competition,
there will be less R&D, fewer new breakthrough drugs, fewer
competitor drugs developed, and ultimately no lower priced generics to
follow. European countries’ price controls imposed in the 1980s prove
the point. In the mid-80s, European drug R&D was 24% higher than in
the U.S. After price controls, European pharmaceutical R&D grew at
half the U.S. rate and today substantially trails American R&D.
Clinton shortsightedly claims we can increase competition for
biologic drugs by lowering the exclusivity period before follow-on
biologics can be approved from 12 to 7 years. Biologics — complex
molecules manufactured in living systems — are particularly difficult to
develop and manufacture. The 12-year period was a compromise crafted by
the Senate Health, Education, Labor and Pension (HELP) committee to
preserve innovation. The committee’s 6/27/2007 press release quoted
Clinton who was a HELP member at the time as saying, “With this
committee’s action today, I am proud that we will both continue the
creativity and innovation that is absolutely essential to our
pharmaceutical industry and the lifesaving treatments and interventions
they are able to provide for us….” Reducing the exclusivity period she
previously lauded will diminish the willingness of companies to risk
development costs and hamstring innovation.
Clinton also proposes eliminating “corporate write-offs for
direct-to- consumer advertising [DTCA].” She claims the tax
deductibility of DTCA subsidizes commercial speech that increases costs
by encouraging patients to ask for unnecessary, expensive medicines. But
there is little evidence DTCA is harmful or drives up costs. Physicians
do not fill prescriptions simply because a patient requests it. The GAO
found that only 2-7% of patients who requested a prescription in
response to DTCA received a prescription for it. And the FDA and others
have reported that DTCA advertising increases patients’ awareness of
disease conditions and new treatments and promotes dialogue with
physicians. Clinton’s plan to establish mandatory FDA pre-clearance of
DTC ads for accuracy and clarity to be funded by pharmaceutical company
user fees is not objectionable. But it is hard to imagine how the
overstretched FDA could do it.
Finally, Clinton promises to convene an expert panel to determine how
much drug companies should invest in R&D “and if they do not meet
their targets, boost their investment or pay rebates to support basic
research.” This, along with her determination to set prices and limit
profits, should alarm technology executives. Their businesses rely on
the internet which was built by government. Will bureaucrats have
license to label Amazon or Facebook profits excessive? Will executives
learn they spent “unreasonable amounts” on marketing and have to pay
back taxes? Will government experts determine what is “sufficient”
R&D spending? This won’t be limited to drug companies or internet
beneficiaries. The Elizabeth Warren — “you didn’t build that” — crowd
thinks government should dictate profits and spending for all private
companies.
First they came for the medical insurers. Then they came for the
pharmaceutical companies. American innovators and tech executives should
worry who’s next."
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