On April 5, 2024, the U.S. Food and Drug Administration (FDA) confirmed that its third-party testing of cosmetic talc products for 2023 identified no traces of asbestos in any of the 50 cosmetic samples tested. FDA’s 2023 results, which were reported in a Cosmetics Constituent Update, are consistent with its testing for 2022 and 2021, which also failed to detect asbestos in any of the 50 cosmetic samples tested for those years. Read the full Alert on Duane Morris’ website.
Community Pharmacists Demand CMS Take Enforcement Action Against PBMs
As news surfaced on February 27 that Congress is punting long-debated pharmacy benefit manager reforms, the community pharmacy lobby demanded CMS immediately take enforcement action against improper PBM practices that the lobby says could cause nearly a third of independent pharmacies to shutter this year. […]
Jonathan Swichar, partner and chair of Duane Morris’ Pharmacy Litigation Group, alleged denying reimbursement and reimbursing at below cost is a tactic used by PBMs to hurt independent pharmacies.
“It’s one of the many initiatives employed by pharmacy benefit managers of the past 10 years to eliminate the competition independent pharmacies pose to their own affiliate pharmacies,” he said. […]
Continue reading “Community Pharmacists Demand CMS Take Enforcement Action Against PBMs”
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.
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.
March-In Rights Imperatives: A CLE Webinar from Ryan C. Smith, Ph.D.
“Has your institution received government funding? Is government funding behind your patents? Are you licensing patents that were developed with government support? If so, you really should listen to this informative webinar. Your rights and economic interests could be dramatically impacted by March-In Rights.”
Discover the nuances of March-In Rights in patent law through a recent presentation by Duane Morris partner, Ryan C. Smith, Ph.D.
To access the presentation, follow this link.
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.
Sanofi Abandons Licensing Deal With Maze Therapeutics After FTC Challenges The Proposed Transaction
On December 11, 2023, Sanofi released a statement that it will terminate its proposed $755 million licensing agreement with Maze Therapeutics (Maze) shortly after the Federal Trade Commission (FTC) issued an administrative complaint and authorized filing a complaint for preliminary injunction in the United States District Court for the District of Massachusetts to block the deal.
Under the terms of the proposed licensing agreement between Genzyme Corporation, a wholly-owned subsidiary of Sanofi, and Maze, Sanofi would acquire an exclusive license to Maze’s glycogen synthase 1 products and related technology, including its candidate MZE001, a drug in development to treat the potentially fatal genetic order Pompe disease. According to a statement by Jason Coloma, Ph.D., Maze’s CEO, the FTC’s challenge “is the first time ever the FTC has moved to block a license of a Phase 1 investigational medicine.” The challenge seems consistent, however, with revised draft merger guidelines proposed by the FTC and Department of Justice that indicate that transactions “should not entrench or extend a dominant position” by, for example, “[e]liminating a nascent competitive threat.”
Bayh-Dole Act March-In Rights Part of White House Plan to Lower Drug Prices
Following enactment of the Inflation Reduction Act, which provides for Medicare drug price negotiations, the White House has announced new actions to lower drug costs, including the release of a proposed framework for agencies to exercise march-in rights under the Bayh-Dole Act to promote public accessibility to tax-payer-funded drugs. If adopted, the framework would make it easier for the government to exercise march-in rights and would impact the value of license rights to government-funded inventions.
Read the full Alert on the Duane Morris LLP website.
FDA Pushes Back Enforcement Deadline for MoCRA Facility Registration and Product Listing Requirements
Today, FDA announced updated guidance regarding its MoCRA rollout.
FDA does not intend to enforce the requirements related to cosmetic product facility registration and cosmetic product listing for an additional six months after the December 29, 2023, statutory deadline, or until July 1, 2024, to provide regulated industry additional time to comply with these requirements.
To read the full text of this post by Kelly Bonner, please visit the Duane Morris Fashion, Retail and Consumer Branded Products Blog.
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.