The Pharmaceutical Care Management Association (PCMA) joined nearly 20 other organizations that support patients and affordable health care to call on Congress to speed generic and biosimilar market entry by ending Big Pharma’s use of patent thickets and protecting the use of skinny labels.
In a letter sent to leaders of the House Judiciary Committee and the Subcommittee on Courts, Intellectual Property, AI, and the Internet, PCMA and others expressed strong support for two bipartisan bills: the Skinny Labels, Big Savings Act (HR 6485) and the Eliminating Thickets to Increase Competition (ETHIC) Act (HR 3269).
Bad practices by large brand pharmaceutical manufacturers hurt competition and keep drug prices high, and PCMA has long advocated for reforms to stop this abuse.
Read the full letter below:
RE: Skinny Labels, Big Savings Act (H.R. 6485), Eliminating Thickets to Increase Competition (ETHIC) Act (H.R. 3269)
Dear Chairman Jordan, Chairman Issa, Ranking Member Raskin, and Ranking Member Johnson:
We, the undersigned list of 20 organizations, urge you to hold a hearing and advance crucial legislation to help reduce costs for America’s patients. Specifically, we urge you to take action on two bills which have bipartisan support – (1) the Skinny Labels, Big Savings Act (H.R. 6485), introduced by Representatives Ben Cline (R-VA) and Zoe Lofgren (D-CA), as well as (2) the Eliminating Thickets to Increase Competition (ETHIC) Act (H.R. 3269), introduced by Representatives Jodey Arrington (R-TX), Lloyd Doggett (D-TX), Darrell Issa (R-CA), and Pramila Jayapal (D-WA).
The Skinny Labels Big Savings Act (H.R. 6485) will ensure that the Hatch-Waxman Act’s longstanding provisions regarding skinny labels are not undermined and that patients can continue to access lower-cost medicines as quickly as possible. Skinny labels allow the generic manufacturer to “carve-out” a brand drug sponsor’s patented methods of use from the generic’s FDA-approved labeling. That carve-out process has served the public interest for over 40 years by increasing access to generic medicines, saving the healthcare system billions of dollars.
According to The American Journal of Managed Care (AJMC), from 2015 to 2020, 15 skinny labels alone generated $14.6 Billion in Medicare savings. Without explicit protection for carve-outs, the existence of a single, indication-specific patent could block generic and biosimilar versions from entering the market, the Skinny Labels, Big Savings Act—would reverse a mistaken decision by the U.S. Court of Appeals for the Federal Circuit which, according to the federal government, “threatens significant harm to competition and to consumers.”
The ETHIC Act (H.R. 3269) will enhance patient access by preventing brand-name pharmaceutical companies from asserting multiple duplicative patents in patent litigation. These duplicative patents create a numbers game for generic and biosimilar companies that ultimately harms patients. Indeed, challenging a large patent estate requires generic and biosimilar manufacturers to engage in years of slow-moving and costly patent litigation to bring their lower-cost medicines to market. The net result is delayed patient access to lower-cost generics and biosimilar medicines. This legislation helps address this patent litigation bottleneck—while also respecting innovation—by requiring brand-name pharmaceuticals to assert only non-duplicative patents in patent litigation.
We look forward to continuing to work with you, as leaders of the committees of jurisdiction, to achieve the enactment of these crucial bills as soon as possible.
Sincerely,
Academy of Managed Care Pharmacy
AHIP
Alliance of Community Health Plans
American Consumer Institute
American Society of Health-System Pharmacists
ASCP (American Society of Consultant Pharmacists)
Association for Accessible Medicines
Blue Cross Blue Shield Association
Campaign for Sustainable Rx Pricing
Consumer Action
Generation Patient
National Alliance of Healthcare Purchaser Coalitions
National Consumers League
PCMA
Public Citizen
R Street Institute
The ERISA Industry Committee
Transparency-Rx
US*MADE
U.S. PIRG
