[Ip-health] WSJ: How Marketing Exclusivity Led to Higher Drug Costs and Questionable Benefits

Andrew S. Goldman andrew.goldman at keionline.org
Tue May 5 10:59:52 PDT 2015


How Marketing Exclusivity Led to Higher Drug Costs and Questionable Benefits

1:23 pm ET
May 5, 2015

Six years ago, the FDA approved a drug called Colcrys to treat acute gout
attacks and familial Mediterranean fever, an inherited inflammatory
disorder. The move came as part of an agency initiative to regulate dozens
of medicines that had never been formally approved, but were on the market
when the FDA received authority to oversee the drug approval process.

In this instance, Colcrys was the brand name given colchicine, which was
sold for decades by several companies and cost 9 cents a pill. URL Pharma
won FDA approval – and seven years of marketing exclusivity – by running a
small study that gauged the effectiveness of different dosages. URL sued
other colchicine makers and, by early 2011, marketing exclusivity took
hold. And Colcrys cost $5 a pill.

Now, a new study says the approval was not worth the effort, at least for
patients. Harvard Medical School researchers examined nearly 217,000
enrollees in an insurance database who were diagnosed with gout or FMF
before and after marketing exclusivity kicked in. Here is what they found:

The likelihood of receiving a prescription for either colchicine or Colcrys
to treat either malady dropped during the year after the marketing
exclusivity took hold – 0.5% per month for gout sufferers and 7.6% for
patients with FMF. Meanwhile, prescription costs and related health care
costs for gout and FMF patients rose during the same period, by 55% and
38%, respectively, according to the study.

“This shows that this type of incentive can go wrong,” says Aaron
Kesselheim, a study co-author and an associate professor of medicine at
Harvard Medical School. “The market exclusivity was granted for behavior
that didn’t provide much public health benefit. But it caused the price to
go up, increased spending by patients and reduced use of the drug, which
has potentially bad public health implications.”

The findings follow substantial criticism that was leveled at the FDA not
long after the approval led to the price hike, since Colcrys was not a new
drug. In its defense, the FDA noted that the drug maker, which was later
bought by Takeda Pharmaceutical, was entitled by law to the marketing
exclusivity. And since FMF is a rare disease, the exclusivity stretched to
seven years, four more than usual.

Moreover, the agency justified the approval for safety reasons – there was
a potentially dangerous risk among people who took colchicine along with
either cyclosporine or clarithromycin. However, the new study, which was
published in the Journal of General Internal Medicine, did not find any
change in the rates of combined prescriptions. We asked Takeda for comment
and will update you accordingly.

Consequently, the study authors argue that the episode offers an
opportunity to revisit the extent to which marketing exclusivity is
granted. In their view, the colchicine example did not produce a sufficient
trade-off between safety and accessibility and, as a result, believe that
the incentives dangled before drug makers ought to be rethought.

The criticism comes as a Congressional committee drafts a sweeping bill
known as 21st Century Cures, which is designed to jump start medical
innovation. An initial version included plans to extend marketing
exclusivity to drug makers as an incentive, although an updated version
last week omitted that section. However, there is placeholder for a section
about repurposing drugs for serious conditions.

“Colchicine is but one data point in a world with countless examples of
inefficient incentives for medical R&D,” says Jamie Love of Knowledge
Ecology International, an advocacy group that focuses on access to
medicines issues. “We have to begin to look at these issues as a financing
problem, and consider new ways to finance these clinical trials.  This
money does not come from Santa Claus. It comes out of our pockets as
consumers, as employers, as taxpayers, and when we buy insurance.”

The FDA would not comment on the study, but pointed us to a recent blog
post about its initiative to regulate unapproved drugs. “If a single
manufacturer is the sole maker of a newly-approved product, the price of
the drug may be higher than what patients and prescribers paid for the
unapproved drug,” the posts says. But the agency does not factor costs into
approvals or safety-related decisions.

For its part, the Pharmaceutical Research & Manufacturers of America, also
would not comment on the study, but sent us a statement saying the trade
group supports “statutory exclusivity provisions that provide incentives
for companies to make the R&D investments necessary to demonstrate the
safety and effectiveness of medicines.”

Andrew S. Goldman
Counsel, Policy and Legal Affairs
Knowledge Ecology International
andrew.goldman at keionline.org // www.twitter.com/ASG_KEI
tel.: +1.202.332.2670

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