FTC

FTC consent order beefs up PBM reforms in spending bill

Wed, 04 Feb 2026 12:00:00 -0500

In a one-two-punch to pharmacy benefit managers (PBMs), the U.S. FTC announced Feb. 4 what it’s calling a “landmark settlement” with the Cigna Group’s Express Scripts Inc. and its affiliates that will require fundamental changes to the company’s business practices.

Edwards scraps Jenavalve buy in face of FTC objections

holland.johnson@clarivate.com — Mon, 12 Jan 2026 11:00:00 -0500

Edwards Lifesciences Corp. said it is scrapping plans to acquire Jenavalve Technology Inc. for $945 million after a federal court ruled against the company in a case brought by the U.S. Federal Trade Commission (FTC) to block the deal.

Teva yields to FTC on Orange Book listings

Thu, 11 Dec 2025 12:00:00 -0500

The U.S. FTC is taking a bow after Teva Pharmaceutical Industries Ltd. asked the FDA to remove more than 200 patent listings from the agency’s Orange Book.

Pfizer, Metsera reach $10B merger agreement as Novo bows out

Mon, 10 Nov 2025 12:00:00 -0500

Pfizer Inc. emerged over the weekend as the winner of the bidding war for Metsera Inc., with the two reaching an amended agreement after market close Nov. 7 that values the obesity drugmaker at about $10 billion. The next day, the other contender, Novo Nordisk A/S, confirmed it does not intend to increase its most recent offer.

Trump hits drug imports with 100% tariffs, starting Oct. 1

Tue, 30 Sep 2025 10:00:00 -0400

The threat of tariffs on imports of branded drugs is about to be realized after U.S. President Donald Trump announced a 100% import duty will apply beginning Oct. 1. However, the flurry of recent announcements by pharma companies of investments in U.S. manufacturing plants may have paid off, with the president saying in his announcement on Truth Social that the 100% rate will be enforced “unless a company is building their manufacturing plant in America.”

Trump hits drug imports with 100% tariffs, starting Oct. 1

Fri, 26 Sep 2025 10:00:00 -0400

FTC advises health care entities on use of noncompete agreements

Tue, 16 Sep 2025 12:00:00 -0400

The U.S. Federal Trade Commission has posted notice to health care companies that their use of noncompete agreements for physicians and nurses may violate the law. The advisory may allow physicians and nurses engaged in clinical trials to move to other employers, thus complicating the conduct of those trials.

US Congress, courts weighing 340B program – again

Thu, 11 Sep 2025 11:00:00 -0400

The debate around the U.S. 340B prescription drug discount program is once again heating up in court and in Congress. A day after the American Hospital Association called on the FTC and Department of Justice to investigate alleged antitrust issues with the rebate models a few drug companies have proposed, some members of Congress raised concerns Sept. 9 about how providers are abusing the program. Meanwhile, a U.S. appellate court heard arguments that same day on whether states can speak in the silence of the federal law that created the program more than 30 years ago.

US FTC to revisit noncompete rule after resounding defeat in court

Mon, 08 Sep 2025 12:00:00 -0400

The U.S. Federal Trade Commission has opened a docket for comment on noncompete employment contracts, a move which suggests that the agency may revert to evaluating these practices on a case-by-case basis rather than by issuing sweeping rules.

US FTC moves to thwart Edwards’ acquisition of Jenavalve

Thu, 07 Aug 2025 12:00:00 -0400

The U.S. Federal Trade Commission (FTC) reported Aug. 6 that it will try to block Edwards Lifesciences Corp.’s proposed acquisition of Jenavalve because Edwards’ acquisition of both Jenavalve Technology Inc. and JC Medical would eliminate competition in the TAVR space for aortic regurgitation.

US FTC snares $14.6M grant for technology upgrades

Wed, 30 Jul 2025 12:00:00 -0400

The U.S. Federal Trade Commission announced a $14.6 million grant it received for an upgrade of its IT infrastructure. The same grant mechanism is leveraged by the Department of Justice, which is a clear sign that U.S. enforcement will be more vigorously enabled by sophisticated analytics going forward.

PBM practices a threat to future of biosimilars, FTC, DOJ told

Mon, 14 Jul 2025 11:00:00 -0400

Once again, U.S. legislative reforms to rein in pharmacy benefit manager (PBM) business practices missed a ride to finally becoming law. This time, they were kicked out of the Trump administration’s budget reconciliation bill that was signed into law July 4. House Resolution 1, as first passed in the lower chamber, included a few PBM reforms, but they were deleted from the Senate version that ultimately became law because the parliamentarian ruled they didn’t meet the restrictions placed on reconciliation measures.

Xlear presses court to force FTC to drop substantiation requirement

Wed, 25 Jun 2025 12:00:00 -0400

Xlear Inc., of Salt Lake City filed a petition in U.S. district court that could terminate the Federal Trade Commission’s practice of demanding substantiation of health care claims.

Xlear presses court to force FTC to drop substantiation requirement

Tue, 24 Jun 2025 12:00:00 -0400

Xlear Inc., of Salt Lake City filed a petition in U.S. district court that could terminate the Federal Trade Commission’s practice of demanding substantiation of health care claims.

FTC active again in enforcement of contact lens rule

Wed, 04 Jun 2025 12:00:00 -0400

The U.S. Federal Trade Commission said it sent letters to 37 contact lens prescribers reminding them a failure to automatically provide patients with a prescription can result in fines of more than $53,000 per violation.

Trump DOJ proposes less intrusive corporate prosecution

Fri, 30 May 2025 12:00:00 -0400

The U.S. Department of Justice is reshuffling its enforcement focus for the coming three years per a May 12 memo attributed to Matthew Galeotti, director of the department’s criminal division. Galeotti said federal attorneys should avoid prosecutorial adventurism in an effort to strike what he described as “an appropriate balance” between enforcement and “unnecessary burdens on American enterprise.”

US legal issues to track in pharma, biotech

Tue, 13 May 2025 11:00:00 -0400

Ongoing policy issues in the U.S., including the Inflation Reduction Act and recent proposals under President Donald Trump’s administration, have wide ranging implications for the global biopharmaceutical industry, speakers at Bio Korea 2025 said May 8, including a heightened need for all biotechs to draft regulatory strategies.

Korea pharma stocks rally; Celltrion welcomes US drug pricing

Tue, 13 May 2025 11:00:00 -0400

Korean pharmaceutical stocks rose across the board May 13, a day after U.S. President Donald Trump signed off on the most favored nation executive order, a drug pricing policy expected to benefit biosimilar makers in the U.S., according to Celltrion Inc.

US legal issues to track in pharma, biotech: Bio Korea 2025

Thu, 08 May 2025 11:00:00 -0400

DOJ rolls out task force for review of burdensome regulation

Fri, 25 Apr 2025 12:00:00 -0400

The U.S. Department of Justice recently announced the formation of a task force that will advocate the roll-back of regulations that affect a wide swath of sectors of the American economy. Health care is one of the areas of interest for the task force, which will examine state as well as federal regulations.

No more ‘fox guarding the henhouse’ under new state PBM law

Tue, 22 Apr 2025 11:00:00 -0400

Tired of waiting for the U.S. Congress to get around to making meaningful reforms to pharmacy benefit manager (PBM) practices, states are beginning to take the matter into their own hands. Arkansas recently became the first state to pass a law stopping PBMs, their affiliates or their parent companies from acting as a "fox guarding the henhouse" by being both a price setter and price taker, as the legislation puts it.

States active on privacy as Congress convenes work group

Fri, 11 Apr 2025 12:00:00 -0400

The thicket of state-based privacy regulation in the U.S. grows thicker by the day, but Congress seems poised to step in with a bipartisan group that may propose legislation that preempts privacy law.

FTC eyeing 23andme’s disposition of genomic data

Tue, 01 Apr 2025 12:00:00 -0400

The financial collapse of direct-to-consumer genetic testing pioneer 23andme Holding Co. is already one of the more notable developments of 2025, but the company’s customers have less to worry about with regard to their data.

Trump halves the FTC, firing Democratic commissioners

Wed, 19 Mar 2025 11:00:00 -0400

The politicization of the U.S. FTC continued March 18 with President Donald Trump firing the two remaining Democratic commissioners, Rebecca Kelly Slaughter and Alvaro Bedoya. The action leaves what’s supposed to be a five-member bipartisan panel with just two members, both of whom are Republicans. The commission already was down one member, as former Chair Lina Khan’s term expired last year and Trump’s appointee, Mark Meador, is awaiting Senate confirmation with a vote expected yet this month.

Still waiting for the dust to settle at US FDA, throughout HHS

Thu, 20 Feb 2025 12:00:00 -0500

With massive terminations, data removals, holds on U.S. government funding, cancellation of various programs and meetings, the potential for 25% tariffs on medical products and a multitude of court challenges and appeals, the dust is flying thick at the FDA, NIH and throughout the Department of Health and Human Services (HHS).

New US FTC report likely to fuel further PBM reforms

Tue, 14 Jan 2025 12:00:00 -0500

Pharmacy benefit managers (PBMs) are under the microscope again, this time for the price markups their affiliated specialty pharmacies charge for generic drugs used to treat cancer, HIV, multiple sclerosis and other serious conditions.

Dual US antitrust enforcement likely to come under pressure in 2025

Thu, 12 Dec 2024 11:00:00 -0500

The fact that both the U.S. Federal Trade Commission and the Department of Justice have oversight of mergers and acquisitions is something of a regulatory oddity. But David Balto, an attorney specializing on antitrust matters, told BioWorld that this may change in 2025 thanks to support for such a move from both Congress and the White House.

Change is the constant in wake of US elections

Fri, 01 Nov 2024 12:00:00 -0400

The drug and device industries have a lot hinging on the results of the Nov. 5 U.S. presidential and congressional elections. Tax policies. The reach of the FTC. Legislation aimed at drug prices, competition, pharmacy benefit managers and lab-developed tests. Cabinet and agency appointments that could reshape Medicare drug negotiations, the 340B program, FDA Orange Book device patent listings, regulatory flexibility and Bayh-Dole march-ins. And that’s just the top of the list.

PBM private labels: Good or bad for US biosimilar market?

Mon, 07 Oct 2024 12:00:00 -0400

A growing foray of pharmacy benefit managers’ (PBMs) private labels into the U.S. biosimilar space is intensifying concerns about the antitrust aspects of PBMs’ vertical integration that has them serving as price negotiator, formulary setter, payer, group purchasing organization, pharmacy, provider and now drug "manufacturer."

Sen. Cassidy: Time for US FDA to reclaim its Orange Book duties

Wed, 02 Oct 2024 12:00:00 -0400

It’s well past time for the U.S. FDA to end its silence on what device patents can be listed in the Orange Book as part of a drug-device combination product, Sen. Bill Cassidy (R-La.) said in an Oct. 1 letter that took FDA Commissioner Robert Califf to task for letting the FTC do the FDA’s job.

FTC

FTC consent order beefs up PBM reforms in spending bill

Edwards scraps Jenavalve buy in face of FTC objections

Teva yields to FTC on Orange Book listings

Pfizer, Metsera reach $10B merger agreement as Novo bows out

Trump hits drug imports with 100% tariffs, starting Oct. 1

Trump hits drug imports with 100% tariffs, starting Oct. 1

​FTC advises health care entities on use of noncompete agreements​

US Congress, courts weighing 340B program – again

US FTC to revisit noncompete rule after resounding defeat in court

US FTC moves to thwart Edwards’ acquisition of Jenavalve

US FTC snares $14.6M grant for technology upgrades

PBM practices a threat to future of biosimilars, FTC, DOJ told

Xlear presses court to force FTC to drop substantiation requirement

Xlear presses court to force FTC to drop substantiation requirement

FTC active again in enforcement of contact lens rule

Trump DOJ proposes less intrusive corporate prosecution

US legal issues to track in pharma, biotech

Korea pharma stocks rally; Celltrion welcomes US drug pricing

US legal issues to track in pharma, biotech: Bio Korea 2025

DOJ rolls out task force for review of burdensome regulation

No more ‘fox guarding the henhouse’ under new state PBM law

States active on privacy as Congress convenes work group

FTC eyeing 23andme’s disposition of genomic data

Trump halves the FTC, firing Democratic commissioners

Still waiting for the dust to settle at US FDA, throughout HHS

New US FTC report likely to fuel further PBM reforms

Dual US antitrust enforcement likely to come under pressure in 2025

Change is the constant in wake of US elections

PBM private labels: Good or bad for US biosimilar market?

Sen. Cassidy: Time for US FDA to reclaim its Orange Book duties

FTC advises health care entities on use of noncompete agreements