C4IP Urges FTC to Proceed with Caution on Addressing Perceived Drug Pricing Problems

The Council for Innovation Promotion (C4IP) submitted its comments on the recent Listening Sessions hosted by the Federal Trade Commission (FTC) and Department of Justice (DOJ) on lowering drug prices in an August 15 letter addressed to Meredyth Andrus, an attorney in the Health Care Division, Bureau of Competition, at the FTC.

The two agencies announced in June that they would be hosting three listening sessions on “lowering Americans’ drug prices through competition” as part of its effort to implement  President Trump’s Executive Order No. 14273, Lowering Drug Prices by Once Again Putting Americans First. The sessions were held June 30, July 24 and August 4 and were invitation-only.

The June 30 session focused on “Anticompetitive Conduct by Pharmaceutical Companies Impeding Generic or Biosimilar Competition”; the July 24 session on “Formulary and Benefit Practices and Regulatory Abuse Impacting Drug Competition “; and the August 4 session on “Turning Insights into Action to Reduce Drug Prices.”

C4IP’s letter explained that the organization felt “compelled to submit comments in response to the recent listening sessions because we are concerned that the sessions have amplified certain false narratives about the U.S. intellectual property system and the role of IP rights in drug development.” The letter also expressed concern that anti-patent voices outnumbered the few pro-patent panelists at the sessions.

The Trump Administration has been focused on lowering drug prices through a number of actions, including his May Executive Order 14297, Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients. Most recently, Trump sent letters to 17 pharmaceutical companies pressing them to deliver on the Order and giving them 60 days to extend Most Favored Nation (MFN) pricing to all Medicaid patients, for newly launched drugs, to return increased revenues from negotiations with countries to American patients, and to provide for direct purchasing options to patients at MFN rates.

According to C4IP, the Listening Sessions included comments from panelists who claimed that granted U.S. patents are often low quality, an assertion that C4IP rejected. Citing a 2024 study by the Sunwater Institute, C4IP said “the USPTO grants invalid patents at a rate of less than 10% — comparing favorably to other major patent offices worldwide.”

C4IP similarly refuted other claims made by some panelists about the relationship between common pharmaceutical practices and drug pricing. For instance, that multiple patents on a drug delay generic entry (commonly known as “patent thickets”); that “product-hopping” practices hinder competition; or that the Hatch-Waxman Act has led to decreased competition for generics in the United States.

The letter also warned against proposals promoting cooperation efforts between the U.S. Patent and Trademark Office (USPTO) and Food and Drug Administration (FDA). “[I]n practice, these initiatives risk adding bureaucracy to two already complex regulatory systems — without clear evidence that they would improve outcomes,” said the letter.

C4IP pointed repeatedly to remarks made by Senator Thom Tillis’ Director of IP Policy, Peter Anthony-Pappas, on August 4, highlighting his statement that “we would not be having a conversation today regarding drug affordability and accessibility if it were not for the U.S. patent system, which encouraged and enabled these drugs to exist in the first place.” Ultimately, the Council urged the Administration to avoid enacting measures that would weaken patent rights under “the false premise of improving affordability.”

C4IP also voiced its concerns about the following pending bills throughout the letter, arguing they attempt to fix problems that largely do not exist or that would significantly hinder medical progress:

• The Affordable Prescriptions for Patients Act (S. 1041)
• Eliminating Thickets to Increase Competition (ETHIC) Act (S. 2276)
• Drug Competition Enhancement Act (S. 1040)
• Interagency Patent Coordination and Improvement Act (S. 1097)
• Medication Affordability and Patent Integrity Act (MAPIA) (S. 2780)

Image Source: Deposit Photos
Author: alphaspirit
Image ID: 66516743