FTC Listening Session Highlights How Big Pharma Undermines Competition from
More Affordable Alternatives





 



THEY SAID IT! CONSUMER ADVOCATES AND EXPERTS SHINE A LIGHT ON BIG PHARMA’S
EGREGIOUS ANTI-COMPETITIVE TACTICS THAT EXTEND MONOPOLIES AND KEEP DRUG PRICES
HIGH

FTC Listening Session Highlights How Big Pharma Undermines Competition from
More Affordable Alternatives



In case you missed it, the Federal Trade Commission (FTC) and Department of
Justice (DOJ) on Monday held alistening session <[link removed]>
on anti-competitive tactics Big Pharma uses to maintain monopoly pricing over
blockbuster brand name products.



Consumer advocates at Monday’s session called for reining in forms of patent
abuse like “patent thicketing” – where a Big Pharma company files dozens or
even hundreds of patents on a single medication to extend exclusivity – that
block competition from more affordable generic or biosimilar alternatives. Such
tactics significantly drive up costs for patients, with patent thickets on just
five drugs amounting to more than$16 billion
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in lost savings over a single year.



Commissioners also heard from experts on a patent abuse tactic known as
“product hopping,” in which a pharmaceutical company blocks competition by
making a small, often insignificant tweak to an existing drug, such as a new
way to administer it or a new dosage level, to extend patent protections and
monopoly pricing power.



Just last month, the FTC announced it would challenge the validity of more
than 200 patents on brand name prescription drugs listed in the U.S. Food and
Drug Administration (FDA)’s Orange Book. The agency’s Orange Book crackdown and
listening session will help shine a light on Big Pharma’s egregious
anti-competitive practices and should add to bipartisan momentum in Congress
for market-based solutions to lower drug prices for the American people.



Here is what experts and advocates had to say during the listening session:



Sneha Dave, Founder & Executive Director, Generation Patient: “We began
initially investigating pharma’s monopolization practices because many of us,
including myself, were on therapeutics like Humira. What we uncovered was that
patents – and not necessarily the cost of ingredients or manufacturing – were
the reasons why our drug prices were so high and why so many of our community
members were unable to afford their therapeutics. While Humira gets a lot of
attention, it is unfortunately not an isolated case. We see lately with Ozempic
having filed over 300 patents – and cases of patent thicketing, product hopping
and pay for delay becoming incredible barriers for our community to be able to
thrive into adulthood and to be able to have meaningful futures. FTC’s work has
shown that brand-name companies are using tactics to undermine price
competition. And they’re using these patent thickets to force generic and
biosimilar drug companies into agreements that restrict access. And that should
be considered anti-competitive… Today, brand name pharma companies are nonstop
patent machines, defining the smallest product changes as innovative and worthy
of patents and making changes just so that they can apply for more patents. And
these are patents that are again not meaningful for patient lives… The current
patent system creates perverse incentives that direct research toward
incremental modifications of existing drugs rather than genuine breakthroughs.”



Alex Brill, Senior Fellow, American Enterprise Institute: “Large, complex,
high stakes drug markets do attract aggressive anti-competitive behaviors… The
collective effects of a host of anti-competitive tactics, some of which we've
already discussed, but including things like patent thickets and product
hopping, raise the risk to manufacturers that the time and cost required to
bring a biosimilar to market will be extended in an unpredictable manner. These
strategies create uncertainty and are unequivocally inefficient.”



Michael Carrier, Board of Governors Professor, Rutgers Law School: “So a
really quick recap of five leading product hopping cases, just in terms of the
facts. First, we have the Tricor case. That was a hard switch. That’s where the
brand company pulls the old version from the market and the market is just left
with the new version. That is what happened in Tricor. Second is the Walgreens
case, which was a soft switch from Prilosec to Nexium. Soft means that Prilosec
remained on the market. Third was the Suboxone case, where the brand firm
raised the original price. It also disparaged the original. It warned of false
safety concerns. Fourth is the Doryx case, which was a hard switch where the
brand company bought back and destroyed capsules. And fifth was the Namenda
case, where the brand version removed the original even before that, and now
it’s the discontinuance. That is all unilateral conduct…



Sometimes we hear that we can’t do anything on product hopping because that
would harm innovation. I think to the contrary. If you remove antitrust
legislation here, then that is a problem. I’ve written about examples like
Tricor and Neurontin and Namenda, where the brand firm had the innovation and
sat on it for years until the generic was about to enter the market. And so, we
need to have robust competition here through legislation and the courts.”



Sneha Dave, Founder & Executive Director, Generation Patient: “We are really
excited about current legislative solutions that exist to reframe and reform
the patent system, namely on legislation related to patent thickets and
USPTO/FDA collaboration to ensure better data sharing between both agencies so
that brand companies are not telling FDA something and USPTO something else… We
would also love to see reforms at the PTO, such as increasing patent examiner
time on scientific patents, so that they have adequate time to review
information. There’s a recent Government Accountability Office report that
showed that patent examiners were begging for extra time.”



Monday’s session was the first of three joint listening sessions taking place
this summer in response to President Trump’s April executive order titled,
“Lowering Drug Prices by Once Again Putting Americans First.” Future sessions
in July and August will discuss regulatory reforms to support greater
competition in the prescription drug marketplace, and solutions to lower drug
prices.



Read more about Big Pharma’s patent abuse HERE
<[link removed]>
.



Read more on bipartisan, market-based solutions to hold Big Pharma accountable
HERE <[link removed]>.



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