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 a listening session 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 highlighted The 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 in lost savings in a single year, according to a May 2023 analysis. Read more on The Affordable Prescriptions for Patients Act HERE.
Senator’s Lee’s chief counsel highlighted The Biosimilar Red Tape Elimination Act, that would eliminate outdated U.S. Food and Drug Administration (FDA) requirements to expedite biosimilar substitution and increase competition from more affordable alternatives to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 By eliminating outdated FDA requirements, this bipartisan, market-based solution will help bring more biosimilars to market more quickly, fostering greater competition from more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 Act HERE.
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.
Read more about Big Pharma’s patent abuse HERE.
Read more on bipartisan, market-based solutions to hold Big Pharma accountable HERE.
###
