THEY SAID IT! BROAD BASED SUPPORT FOR BIPARTISAN ETHIC ACT AND SKINNY LABELS, BIG SAVINGS ACT

Health Care Leaders and Policy Experts Agree Bipartisan, Market-Based Solutions Would Boost Competition, Lower Prescription Drug Prices

Big Pharma blocks competition by gaming the patent system, creating “patent thickets” – where drug companies file dozens or hundreds of patents on a single drug to block more affordable alternatives to high-priced brand name drugs from entering the market, for months, years or even decades. Generic and biosimilar development is delayed or blocked entirely, keeping more affordable alternatives from entering the market and driving down drug prices through greater competition.

Congress can act immediately to hold Big Pharma accountable by advancing two bipartisan, market-based solutions: The Eliminating Thickets to Improve Competition (ETHIC) Act and Skinny Labels, Big Savings Act.

The bipartisan ETHIC Act (S.2276 / H.R.3269) targets Big Pharma’s abuse of the patent system to restore fair competition. By cutting down on excessive, duplicative drug patents that Big Pharma uses to extend monopoly pricing, the ETHIC Act directly confronts a key driver of high drug costs.

The legislation streamlines patent litigation by limiting the number of patents per patent thicket a pharmaceutical company can assert to one, while still safeguarding quality patents that improve existing drugs. This promotes faster market entry of lower-cost generics and biosimilars, ultimately saving money for patients and taxpayers by encouraging real market competition.

Here is what health care leaders and policy experts had to say about the ETHIC Act:

“CSRxP commends U.S. Senators Welch (D-VT), Hawley (R-MO), Klobuchar (D-MN), U.S. Representative Jodey Arrington (R-TX-19) and all the sponsors of the ETHIC Act for their commitment to holding Big Pharma accountable for egregious abuse of the patent system that keeps prescription drug prices high for American patients. Anti-competitive tactics, like patent thicketing, enable Big Pharma to extend monopoly pricing on blockbuster products, costing patients, taxpayers and the U.S. health care system billions of dollars each year. Fostering greater competition by cracking down on Big Pharma’s patent abuse will bring more affordable alternatives to the market earlier and help lower prices for patients,” said CSRxP executive director Lauren Aronson.

“The ETHIC Act is an important first step in helping curb the legal schemes the pharmaceutical industry uses to build patent thickets that are then used to extend their market monopoly and block competition at the expense of payers and patients. For too long, our patent system has been captured by the interests of the pharmaceutical industry. The ETHIC Act would help to correct some of that power imbalance,” said Tahir Amin, Co-Founder and chief executive officer of the Initiative for Medicines, Access & Knowledge (I-MAK).

“Patent thickets impose a major barrier against patients who need high-quality and affordable generic drugs. Rep. Arrington’s commonsense proposal would ensure drug manufacturers cannot game our patent system to artificially raise the cost of important medications. This will help put patients back in charge of their healthcare decisions,” said Governor Bobby Jindal, Chair of the Center for a Healthy America at The America First Policy Institute.

“In response to concerns about patent thickets and strategic patenting that aim to deter entry rather than foster innovation, the ETHIC Act has been introduced in both the House and the Senate. The legislation is a narrow fix that would limit the number of patents a brand manufacturer can assert in an infringement action brought by a generic or biosimilar manufacturer. More specifically, the legislation targets patent thickets by restricting a patent holder to asserting only one patent per ‘patent group’ when challenged by a generic or biosimilar, where a patent group is defined as a set of patents linked by terminal disclaimers… The ETHIC Act would limit these practices to encourage greater competition by biosimilars and generics,” said Wayne T. Brough, Resident Senior Fellow, Technology and Innovation, R Street Institute.

“As an organization representing over 25 million young adults with chronic conditions in the United States, we witness daily the barriers to accessing affordable, life-saving medicines. For young adults striving for financial security and independence, these obstacles to accessing necessary medicines are especially daunting. With the leadership of Senators Welch and Hawley, the ETHIC Act represents a pragmatic step toward closing loopholes that allow brand-name pharmaceutical companies to use overlapping patents to block competition. By limiting infringement claims to one patent per group of closely related patents, this legislation promotes fair competition and enables more affordable treatment options for our community. It is time to prioritize the health and futures of patients, and this legislation is a step forward in that direction,” said Sneha Dave, Founder and Executive Director, Generation Patient.

“Patent thickets increasingly serve as a barrier to patient access to lower-cost generic and biosimilar medicines. The Arrington-Issa bill proactively addresses anticompetitive patent thickets by limiting brands to a single patent out of a duplicative patent family in Hatch-Waxman and biologics patent litigation. The bill, which aligns with the Administration’s Executive Order on competition, will accelerate generic and biosimilar launches and stop these problematic double patenting practices,” said John Murphy, President and CEO of the Association of Accessible Medicines.

The bipartisan Skinny Labels, Big Savings Act (S.43 / H.R.6485) would help ensure the skinny labeling process functions as Congress intended, preserving legitimate patent rights while preventing anti-competitive abuse of the system that keeps drug prices high.

The longstanding practice known as skinny labeling has fostered competition for decades by helping more affordable generic and biosimilar alternatives to high-priced brand name drugs enter the market, generating substantial savings for patients, taxpayers and the health care system. But recent legal challenges from Big Pharma have weakened this framework, creating additional opportunities for brand name drug companies to delay and block more affordable alternatives from reaching American patients.

Here is what health care leaders and policy experts had to say about the Skinny Labels, Big Savings Act:

“CSRxP commends Senators Hickenlooper, Welch, Cotton and Collins for highlighting the importance of protecting and fostering robust competition from more affordable alternatives to high-priced brand name prescription drugs. Their legislation would help strengthen and protect the use of skinny labels that substantially reduce barriers to entry for generic drugs and save patients and the U.S. health care system billions of dollars — preventing Big Pharma from gaming the system to undermine the full value of this critical pathway,” said Lauren Aronson, Executive Director of Campaign for Sustainable Rx Pricing.

“The Skinny Labels, Big Savings Act preserves a crucial pathway for ensuring patients can continue to access affordable, life-saving generic medicines at prices they can afford. Major drug corporations routinely abuse the patent system to extend their monopolies, block competition and set exorbitant prices that harm patients. This legislation provides a counterweight by codifying legal protections for skinny labeling into law. It maintains incentives for generic entry by shielding skinny labels from patent challenges, increasing savings for patients and taxpayers. We urge Congress to pass this pro-competition, pro-patient bill – to keep reining in Big Pharma’s pricing abuses,” said Merith Basey, Executive Director of Patients For Affordable Drugs NOW.

“Since the passage of Hatch-Waxman 40 years ago, skinny labeling has saved patients and the health care system billions of dollars annually. Without hesitation, AAM applauds and supports legislation that will provide a safe harbor for skinny labeling, propelling patient access to lower-cost generic medications and protecting the overall health care system. Thank you to Senators Hickenlooper, Cotton, Welch, and Collins, as well as the committees of jurisdiction for their hard work on behalf of patients,” said John Murphy III, President and CEO for the Association of Accessible Medicines.

“The Generics Access Project, a coalition of patient advocacy groups across disease states, applauds Senator Hickenlooper, Senator Cotton, Senator Collins, and Senator Welch for their proactive efforts to protect the skinny labeling of generic medicines – a critical pathway that has enabled timely patient access to high quality, affordable treatments for 40 years. Millions of patients rely on generic drugs that have been lawfully approved by the FDA with skinny labels. This safe harbor amendment is essential to ensuring the continued availability of generic medicines, ensure new generics are developed and helping bring affordable medicines to patients,” said The Generics Access Project.

Congress can deliver lower drug prices for hardworking Americans by supporting these bipartisan, market-based solutions to crack down on Big Pharma’s anti-competitive tactics and help more affordable generic and biosimilar alternatives enter the market more quickly.

Read more about the ETHIC Act and Skinny Labels, Big Savings Act HERE.

Read more about how biosimilar competition lowers out-of-pocket costs for patients HERE.

Read more on how Big Pharma games the system to block competition and keep drug prices high HERE.

Read more on bipartisan, market-based solutions to hold Big Pharma accountable HERE.