[Ip-health] Clinton Has Evolved on Specialty Drug Policies

Claire Cassedy claire.cassedy at keionline.org
Tue Oct 20 06:21:04 PDT 2015


Clinton Has Evolved on Specialty Drug Policies

Jon Reid   |   October 13, 2015

Presidential candidate Hillary Clinton opposes a law she spearheaded while
in the Senate. The law, now part of Obamacare, prevents cheaper versions of
complex drugs from being sold for 12 years after Food and Drug
Administration approval.

Clinton’s change in position coincides with a broader shift among health
care policymakers about how to regulate new specialty drugs, which can cost
drug makers billions to develop and be expensive for patients.

But to her opponents, Clinton’s shift can also be labeled a flip-flop. The
head of the Pharmaceutical Research and Manufacturers of America has
already decried candidate Clinton’s drug pricing policies as “driven by the
false notion that spending on medicines is fueling overall health care cost

The Democratic presidential frontrunner said last month that she wants to
reduce the length of time a drug maker has exclusive rights to drugs called
biologics. Biologics consist of living cells and cannot replicated into
generics like regular drugs. Imitations of biologic drugs are called

Clinton argues that reducing the length of exclusivity from 12 years to
seven years would make those treatments more affordable because rival drug
makers could sell cheaper copycat versions sooner.

But Clinton has not always held this position. When she was in the Senate
eight years ago, she was a key player in crafting legislation granting
biologic drugs 12 years of exclusivity. At the time, Sen. Clinton (D-N.Y.),
along with Sens. Ted Kennedy (D-Mass.), Orrin Hatch (R-Utah), Mike Enzi
(R-WY.) and Chuck Schumer (D-N.Y.), spearheaded the Biologics Price
Competition and Innovation Act of 2007, which laid the framework for
regulating the sale of biologics and their copycat versions.

Even as that bill was being considered, Clinton had concerns about granting
12 years exclusivity for biologics, according to a campaign aide who works
for her now. But, the aide said, Clinton agreed to support the bill anyway
because it created a regulatory pathway for biosimilars to be sold in the
United States. Up until that point, there was no such path, which meant
that complex and potentially life-saving drugs were out of reach for much
of the general public.

That particular bill did not become law, but its provisions were codified
in the Affordable Care Act, which President Barack Obama signed in 2010.

Some of Clinton’s Senate colleagues have also evolved on the issue since
the original biologics proposal was drafted. Schumer, who worked with
Clinton on the biologics bill, said in 2011 that he was opposed to 12 years
exclusivity for specialty drugs.

The pharmaceutical industry argues that longer exclusivity periods are
necessary for biologics because they are more complex than regular drugs
and can cost billions to research and develop. Clinton, on the other hand,
believes that reducing the exclusivity period for biologics to seven years,
two years longer than the non-compete period for chemical drugs, is still

Clinton’s views on drug pricing are important because for much of her
public life she has been a major figure on health policy. As First Lady,
Clinton led an intense if unsuccessful effort at passing universal health
care legislation. She was a major proponent for the State Children’s Health
Insurance Program. She also served on the Senate Health, Education, Labor
and Pensions Committee between 2001 and 2009.

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