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Aug 29, 2024 | 
lexology.com | Philip Katz |Chuck Loughlin |Gary Veron |Komal Karnik Nigam |Ilana Kattan |Jason Conaty | +3 more
This is the fourth comment related to the pharmaceutical industry the FTC has submitted to various agencies since the beginning of 2024, and part of a broader effort by the FTC to prioritize “safeguarding fair competition and rooting out unlawful business practices in health care markets.”[1] FTC says FDA’s Draft Guidance on interchangeability will increase competition in biologic marketplaces Under the Public Health Service Act, the standard for interchangeability is that a biosimilar “can...
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Jul 5, 2024 | 
jdsupra.com | Logan Breed |Ilana Kattan |Chuck Loughlin
9 See id. at 7-35. 10 Id. at 5. 11 Id. at 16 (quoting Skidmore v. Swift & Co., 323 U.S. 134, 140 (1944)). 12 Id. at 3513 The FTC’s rulemaking authority is governed by Section 6(g) of the FTC Act. 15 U.S.C. Sec. 46(g), “Additional powers of Commission.”14 See Federal Trade Commission, “Policy Statement Regarding the Scope of Unfair Methods of Competition Under Section 5 of the Federal Trade Commission Act,” Commission File No. P221202 (Nov. 10, 2022) available here.
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Jun 27, 2024 | 
concurrences.com | Hogan Lovells |Logan Breed |Chuck Loughlin |Ilana Kattan
Previous article Next article Share on | On June 28, 2024, the U.S. Supreme Court issued a highly anticipated decision overturning the 40-year old precedent established in Chevron, U.S.A. v. Natural Resources Defense Council.
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Jun 27, 2024 | 
concurrences.com | Hogan Lovells |Logan Breed |Chuck Loughlin |Ilana Kattan
On June 28, 2024, the U.S. Supreme Court issued a highly anticipated decision overturning the 40-year old precedent established in Chevron, U.S.A. v. Natural Resources Defense Council. [1] Under the Chevron doctrine, courts were required to give deference to administrative agencies’ interpretations of the statutes they administer when those statutes were ambiguous. The court’s 6-3 decision (along party lines) to eliminate “Chevron deference” leaves interpretations of administrative statutes...
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May 7, 2024 | 
jdsupra.com | Jason Conaty |David Fox |Ilana Kattan
The new warning letters are the latest salvo in the FTC’s expanded “campaign against pharmaceutical manufacturers’ improper or inaccurate listing of patents” in the Orange Book.
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May 6, 2024 | 
lexology.com | David Fox |Philip Katz |Chuck Loughlin |Gary Veron |Jason Conaty |Ilana Kattan | +2 more
On April 30, 2024, the Federal Trade Commission (FTC) announced that it sent a new set of warning letters to ten pharmaceutical companies. The letters inform the companies that the FTC has notified the Food and Drug Administration (FDA) that the Commission is disputing 300 allegedly “improper or inaccurate” patent listings in the FDA Orange Book.
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Apr 8, 2024 | 
jdsupra.com | Ilana Kattan |Chuck Loughlin |Jill Ottenberg
On March 22, 2024, the FTC filed an amicus brief in support of a generic drugmaker that was sued by a brand manufacturer for patent infringement related to an asthma inhaler.2 The generic manufacturer filed antitrust counterclaims alleging that the brand manufacturer improperly listed patents for dose counters and inhaler devices in the FDA’s Orange Book as a way to delay generic entry.
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Mar 13, 2024 | 
jdsupra.com | Ashley Ifeadike |Ilana Kattan |Chuck Loughlin
The FTC workshop included speakers from federal government agencies including the FTC, Department of Justice (DOJ), and Department of Health and Human Services (HHS), as well as academics, health care practitioners, economists, and public interest groups. The workshop concluded with a Q&A between Rhode Island Attorney General Peter Neronha and FTC Commissioner Rebecca Slaughter.
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Feb 26, 2024 | 
lexology.com | Robert Baldwin |Logan Breed |Ken Field |Michele Harrington |Ilana Kattan |Eric Saga
In late January 2024, the Federal Trade Commission (“FTC”) released an updated operating plan in the event Congress does not pass a funding bill and the government shuts down. In a dramatic departure from prior practice, the FTC for the first time plans to also close down its premerger filing operations during such a scenario. This change will prevent merging parties from making required Hart-Scott-Rodino (“HSR”) filings and starting required HSR pre-closing waiting periods during the shutdown.
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Dec 20, 2023 | 
lexology.com | Logan Breed |Edith Ramirez |Chuck Loughlin |Ken Field |Justin Bernick |Ashley Howlett | +3 more
On December 18, 2023 the Federal Trade Commission (FTC) and Department of Justice (DOJ) (“the Agencies”) released the 2023 Merger Guidelines (the Merger Guidelines). The substance of the new guidelines does not stray significantly from the Agencies’ Draft Merger Guidelines published in July 2023, and contains most of the same expanded theories of harm first laid out there by the Agencies.
