Joint DOJ- FTC Listening Session Focuses on Solutions to Foster Greater
Competition from More Affordable Alternatives





 



THEY SAID IT! U.S. SENATE EXPERTS HIGHLIGHT BIPARTISAN, MARKET-BASED SOLUTIONS
TO HOLD BIG PHARMA ACCOUNTABLE FOR PATENT ABUSE, BOOST COMPETITION TO LOWER
DRUG PRICES

Joint DOJ- FTC Listening Session Focuses on Solutions to Foster Greater
Competition from More Affordable Alternatives



In case you missed it, the Federal Trade Commission (FTC) and Department of
Justice (DOJ) held alistening session
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on Monday with policy and legal experts representing the offices of U.S.
Senators John Cornyn (R-TX), Mike Lee (R-UT) and Chuck Grassley (R-IA), to
discuss lowering prescription drug prices in the U.S. by fostering greater
competition.



The panel highlighted several bipartisan, market-based solutions that would
help bring more affordable alternatives, like generics and biosimilars, to the
market more quickly. Senator Cornyn’s chief counsel highlightedThe Affordable
Prescriptions for Patients Act, or Cornyn-Blumenthal, that would crack down on
Big Pharma’s egregious use of patent thickets, where pharmaceutical companies
file dozens, even hundreds, of patents on a single medication to extend
exclusivity and block competition from more affordable generic or biosimilar
alternatives for months, years or even decades. Patent thickets on just five
brand name drugs cost American patients and the U.S. health care system more
than$16 billion
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in lost savings in a single year, according to a May 2023analysis
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. Read more on The Affordable Prescriptions for Patients ActHERE
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.



Senator’s Lee’s chief counsel highlighted The Biosimilar Red Tape Elimination
Act, that would eliminate outdated U.S. Food and Drug Administration (FDA)
requirements to expedite biosimilar substitution and increase competition from
more affordable alternatives to high-priced brand name products. By eliminating
outdated FDA requirements, this bipartisan, market-based solution will help
bring more biosimilars to market more quickly, fostering greater competition
from more affordable alternatives to high-priced brand name drugs to help lower
prices for patients, taxpayers and the U.S. health system. Read more on The
Biosimilar Red Tape Elimination ActHERE
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.



Here is what panel had to say during the listening session:



Franci Rooney Becker, Chief Counsel to Senator John Cornyn (R-TX), Senate
Judiciary Committee: “The Senator [Cornyn] has two bills introduced that were
both reported unanimously out of the Senate Judiciary Committee earlier this
year and have been for multiple Congresses that would tackle two particular bad
behaviors that, in the Senator’s view, impede this increased access to generics
and biosimilars. The first is the Affordable Prescriptions for Patients Act,
which would target the use of patent thickets in the patent dance…. It
addresses patent thickets in the context of the patent dance… The patent dance
is a voluntary pathway, and over the course of the last 15 years, it has not
functioned as intended. Part of this is because it has not created the
efficiencies that were intended in terms of litigating the patents at issue. So
what Affordable Prescriptions For Patients does is it says if you participate
voluntarily in this patent dance, then the number of patents to be litigated is
limited to kind of the foundational patents, the ones that really have to be
litigated, the ones that are like about the actual molecular structure and so
on and then in return, the reference product sponsor has to provide all the
information that they have about the drug's manufacturer. This was what we saw
as a problem in the patent dance – you had two parties who didn't really trust
each other and because it was a voluntary pathway, you had a kind of I'll show
you mine, you show me yours issue, so you had a failure of information and then
huge amounts of patents need to be litigated.



…The second bill that Senator Cornyn has is the Drug Competition Enhancement
Act. This bill addresses another particular behavioral issue. This is an
antitrust issue called product hopping. Product hopping occurs when a
manufacturer creates a follow-on product, a new product that treats the same
condition but is an improvement in some way - extended release tablets, or
things of this nature. But the problem is that their new product is facing many
more years of exclusivity, and their old product, which is still approved and
still functional, can be close to coming off exclusivity with the generics
coming down the pike. And so sometimes a manufacturer will behave in an
anti-competitive manner as to the original product, as to the old drug that is
coming off exclusivity. This is a very important point because the follow-on
produces innovation and development. Growth is good, we want to incentivize
that. We would never want to create a situation where people do not want to
create new drugs, but just because you have a new drug does not mean you can
make misrepresentations or otherwise behave in an anti-competitive manner
regarding your original product.”



Thomas DeMatteo, Chief Counsel to Senator Mike Lee (R-UT), Senate Judiciary
Committee:“Another critical issue is the pricing and availability of
prescription drugs. Pharmaceutical companies invest billions in research and
development and rely on patent protections to recoup those investments. Well,
patents are essential to incentivize innovation; they also create temporary
monopolies that allow companies to charge higher prices. Biosimilars are
beginning to ease the burden of high-cost biologics, although their initial
price discounts tend to be more modest due to higher development costs and
regulatory barriers. Even so, biosimilars have saved the U.S. healthcare system
an estimated $21 billion over the past five years. Senator Lee has championed
two bills that would bring reform in this area. First, the Biosimilar Red Tape
Elimination Act would streamline access by making FDA-approved biosimilars
automatically interchangeable once deemed safe and effective. Given that modest
increases in biosimilar uptake are projected to save tens of billions of
dollars, this is a common sense reform to accelerate access to affordable
therapies. Second, the Short On Competition Act would empower the Secretary of
Health and Human Services to expedite reviews, inspections, and temporary
importation in the event of a drug shortage. The bill would also allow for
expedited review and importation of drugs approved for more than 10 years that
have fewer than five suppliers in the market.”



John Lee, Chief Counsel for Intellectual Property, House Judiciary Committee:
“American consumers pay and American patients pay higher drug prices than any
other people in essentially the entire world, certainly in developed countries.
There are many countries where the same medicines are available. They're just
available cheaper. And why are American consumers disadvantaged?... There are a
number of solutions that we're looking at in the House Judiciary Committee to
address the balance of patent rights as part of, you know, solutions to the way
drug prices are going. Certainly, we support the efforts of the Trademark
Office in improving prosecution accuracy [for] the patents issued by a terminal
disclaimer, at least the ones that are issued under the Ethic Act. These are
situations where there has been a patent issued and then other patents issued
that the patent office has determined to be not patentably distinct from the
original patent. So they’re the same invention, and our system is strange in
that you’re allowed to get more patents on the same thing. When that happens,
though, that shouldn’t be abused in order to deter generic and biosimilar
companies."



Nicholas Pottebaum, Health Policy Advisor, Office of Senator Chuck Grassley
(R-IA): “The growing availability of generic drugs and biosimilars in the
recent decades has also resulted in higher utilization of lower-cost
treatments… The Senate Judiciary Committee under Chairman Grassley's leadership
this Congress has marked up and passed reforms to end pay-for-delay deals, curb
the use of sham citizen petitions, deter product hopping, crack down on patent
abuse, as well as improved coordination between the Patent and Trademark Office
and the FDA.”



Read more from previous joint DOJ-FTC listening sessions HERE
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.



Read more about Big Pharma’s patent abuse HERE
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.



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



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