FTC – Duane Morris Life Sciences Law

February 15, 2024 by Duane Morris

FTC Voices Support for March-In Rights on Patents to Help Control Drug Prices

The Federal Trade Commission (FTC) has announced its support of the federal government’s use of “march-in rights” as a mechanism to control the price of pharmaceuticals. The National Institute of Standards and Technology (NIST) late last year issued its “Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights” that would fundamentally change the use of march-in rights by allowing the government to exercise price control under the Bayh-Dole Act, which the FTC announced its support for last week. This shift is the latest effort by federal agencies to lower drug prices in the wake of President Joe Biden’s Executive Order on Promoting Competition in the American Economy.

Read the full Alert on the Duane Morris LLP website.

January 30, 2024 by Sarah O'Laughlin Kulik

Senator reiterates FTC warnings regarding inhaler patents in Orange Book

Senator Tammy Baldwin (D-WI) sent letters this week to companies warning of improper Orange Book listings of patents for inhalers, following up on the FTC’s focus on potential anticompetitive harm of improper listings. According to Senator Baldwin’s letters, the recipients of the letters were warned by the FTC in November regarding the listing of inhaler patents, but have not removed the patents from the Orange Book. The letters follow an investigation launched earlier this month by the Senate Committee on Health, Education, Labor, and Pensions (of which Senator Baldwin is a member) into the prices of inhalers.

December 18, 2023 by Sarah O'Laughlin Kulik

FTC and DOJ Finalize 2023 Merger Guidelines

Today, the Federal Trade Commission (“FTC”) and Department of Justice (“DOJ”) (collectively, the “Agencies”) jointly released the 2023 Merger Guidelines . The 2023 Merger Guidelines outline the “factors and frameworks the agencies utilize when reviewing mergers and acquisitions,” including both horizontal and vertical transactions. The 2023 Merger Guidelines finalize the draft merger guidelines that were released in July 2023 and effectively update and replace the 2010 Horizontal merger Guidelines and Vertical Merger Guidelines that were issued in 2020 and later rescinded by the FTC in 2021. The 2023 Merger Guidelines are not law, but past merger guidelines have been persuasively cited by courts, and they give insight as to how the Agencies view the competitive impact of transactions.

Given the Agencies’ focus on competition in the Life Sciences space, companies should be aware of all of the factors and frameworks outlined in the 2023 Merger Guidelines. In particular, certain components of the 2023 Merger Guidelines reflect recent enforcement trends, including the threshold for when the Agencies consider certain transactions presumptively illegal, an emphasis on elimination of potential entrants in concentrated markets, a focus on how transactions will affect access to products or services used by rivals, an examination of whether a transaction furthers an already-dominant market position or is part of a trend towards consolidation, and concerns with both cross-ownership and common ownership in firms that have competitive relationships.

November 8, 2023 by Sarah O'Laughlin Kulik

Federal Trade Commission Issues Notice Letters Regarding Allegedly Improper Orange Book Listings

On November 7, 2023, the Federal Trade Commission (“FTC”) announced that it had issued notice letters to 10 life sciences companies regarding 100 patents that the FTC contends are improperly listed in the Orange Book, the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations. The announcement comes of the heels of the FTC’s policy statement warning drug companies that improper listing of patents in the Orange Book could violate Section 5 of the FTC Act. Pursuant to the FTC’s policy, the companies have 30 days to either withdraw or amend their listings or certify under penalty of perjury that the listings are proper.

The FTC believes that improper listings in the Orange Book could constitute an unfair method of competition under Section 5 of the FTC Act because a patent listed in the Orange Book could lead to a statutory stay that generally blocks the introduction of competing products for 30 months. According to the FTC, costs associated with challenging patents could frustrate innovation and/or market entry. The FTC has said that even a brief delay in generic entry harms consumers in the form of artificially high drug prices.

We will be watching how companies choose to respond to the recent notice letters and the policy’s impact on Orange Book listings and competition with respect to brand drugs going forward.

September 26, 2023 by Duane Morris

FTC Targets Private Equity in Challenge to Anesthesiology Roll-Ups

On September 21, 2023, the Federal Trade Commission sued U.S. Anesthesia Partners Inc. and Welsh, Carson, Anderson & Stowe XI L.P., among other private equity funds, in the United States District Court for the Southern District of Texas under the antitrust laws. Specifically, FTC alleges that the defendants engaged in an anti-competitive scheme to consolidate anesthesia practices in Texas and to force other independent anesthesia groups into price-setting arrangements that violated Section 2 of the Sherman Act, Section 7 of the Clayton Act and Section 5 of the FTC Act.

To read the full text of this Duane Morris Alert, please visit the firm website.

September 19, 2023 by Sean P. McConnell

FTC Issues Policy Statement Cautioning Branded Drug Companies Against Improper Orange Book Listings

Duane Morris Takeaways: On Thursday September 14, 2023, the FTC issued a policy statement warning brand drug companies that improper listing of patents in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, commonly referred to as the “Orange Book” could violate Section 5 of the FTC Act. The Hatch-Waxman Act and FDA regulations outline the criteria that brand drug companies must follow for listing patents in the Orange Book. Brand drug manufacturers that list patents in the Orange Book may obtain a 30-month stay of generic competition. According to the FTC, certain brand drug manufacturers have failed to follow that criteria, in some cases by submitting patents for listing in the Orange Book that claim neither the reference listed drug nor a method of using it. Under the new policy statement, FTC will scrutinize improper listings as a potential method of unfair competition under Section 5 of the FTC Act.

The policy statement is required reading for any corporate counsel involved in the submission of patent information in the Orange Book.

Implications for Brand Drug Manufacturers: Under the regulatory processes set up by Congress, the person who submits the patent information in the Orange Book listing must attest under penalty of perjury that the submission complies with the regulations. Drug manufacturers and individuals responsible for submitting such information are now on notice that the FTC intends to scrutinize improper Orange Book listings to determine whether they constitute an unfair methods of competition under Section 5 of the FTC Act or illegal monopolization. The policy statement also warns that individuals who submit or cause the submission of improper Orange Book patent listings may be held individually liable, including potentially having such cases referred to the U.S. Department of Justice for further investigation.

June 28, 2022 by Duane Morris

FTC Publishes Proposed Changes to Guides Concerning the Use of Endorsements and Testimonials in Advertising

The Federal Trade Commission (FTC) has announced proposed changes to its Endorsement Guides, 16 CFR Part 255, which assist entities in conforming endorsements and testimonials in advertising to the requirements of Section 5 of the FTC Act. FTC continues to review the guides, first published in 1980, as part of its ongoing regulatory review process.

To read the full text of this Duane Morris Alert, please visit the firm website.

April 27, 2021 by Duane Morris

SCOTUS Curbs FTC’s Enthusiasm by Limiting Relief Available Under Section 13(b) of the FTC Act

On April 22, 2021, the Supreme Court of the United States unanimously held that Section 13(b) of the Federal Trade Commission Act does not authorize the FTC to seek, or a court to award, equitable monetary relief. The decision is likely to have a significant impact on the FTC’s decision-making process in bringing future cases directly to federal district court, as opposed to going through the administrative process, and it will likely spur congressional debate and possibly lead to new legislation.

To read the full text of this Duane Morris Alert, please visit the firm website.

December 17, 2020 by Duane Morris

FTC Announces Crackdown on Deceptive Marketing of CBD Products

In connection with a crackdown on CBD manufacturers pursuant to its “Operation CBDeceit,” the FTC announced today settlements with six CBD-infused product manufacturers who, according to the FTC, allegedly made a “wide range of scientifically unsupported claims about their ability to treat serious health conditions, including cancer, heart disease, hypertension, Alzheimer’s disease, and others.” Under the settlements of the respective complaints against them, each of the manufacturers will be required to pay a fine, and cease making “unsupported health claims” in connection with the marketing of their products.

To read the full text of this post by Duane Morris partner Seth Goldberg, please visit the Duane Morris Cannabis Industry Blog.

December 11, 2019 by Duane Morris

Spate of FDA and FTC Warning Letters Sets Stage for Wave of False Advertising Consumer Class Action Lawsuits

Since the 2018 Farm Bill passed in December 2018, removing hemp from the Controlled Substances Act and thus legalizing it under federal law, consumer goods containing the hemp-derivative cannabidiol (CBD) have become exceptionally popular. With that growing popularity among consumers has come increased scrutiny by federal regulators whose mission is consumer safety and protection, such as the Food and Drug Administration and Federal Trade Commission, and now by the plaintiffs’ bar, which files consumer class actions based on advertising. As the recent spate of warning letters and consumer class actions demonstrate, hemp-derived CBD product manufacturers and others in the supply chain for those products have to be mindful of the claims they make to consumers about their products.

View the full Alert on the Duane Morris LLP website.