The fight over copycat weight-loss drugs escalates

State of play: At issue is whether compounded GLP-1 drugs can still be widely sold after the FDA declared that the blockbuster anti-obesity treatments were no longer in shortage.

• Telehealth company Hims & Hers backed off plans to sell a compounded version of the Wegovy pill this week after the FDA threatened regulatory action and the Department of Health and Human Services referred the company to the Justice Department for potentially violating federal drug law.
• Hims & Hers still is offering its versions of injectable weight-loss drugs, leaving open questions about whether regulators will act against those next. The company also is facing a patent infringement suit from Wegovy's maker, Novo Nordisk.

What they're saying: "In some instances, it seems like Hims is doing their best to get right up to the line of what the [compounding law] allows," said Jacob Sherkow, a law professor at the University of Illinois.

• Efforts like Hims' short-lived attempt to launch its own version of the Wegovy pill "don't necessarily pass the sniff test," he said.

The big picture: If Hims & Hers prevails, it and other companies could try to do the same for other types of drugs, which critics say would further undermine the U.S. drug approval system and FDA checks on safety and efficacy.

• "If Hims somehow wins this, or some other compounding pharmacy learns a lesson from Hims' missteps, I would imagine that they would do this [for other drugs]," Sherkow said.
• "Patients like buying drugs from apps, let's just be honest."
• That would put telehealth companies in competition with the Trump administration, which has been negotiating lower prices for branded GLP-1s and other treatments.
• It has been touting them on its TrumpRx platform, though for more than the compounded versions.

Former FDA commissioner Scott Gottlieb addressed the showdown on CNBC this week, saying, "We have a drug approval process for a reason, to ensure that drugs are safe and effective."

• "If any company can operate under the guise of a pharmacy license, come up with completely novel formulations of drugs and market them directly to consumers, why have a drug approval process?" he asked.

The other side: Hims & Hers issued a defiant statement after Novo Nordisk announced its lawsuit, arguing it is standing up for "choice, affordability and access."

• "Once again, Big Pharma is weaponizing the U.S. judicial system to limit consumer choice," Hims said in a statement.

Between the lines: Both sides acknowledge there are times when companies should be able to make customized versions tailored to patients' needs.

• A patient who's allergic to an ingredient in the FDA-approved version could get a compounded version with the active ingredient but without the allergen.
• Compounded versions also helped fulfill consumer demand when brand-name GLP-1s from Novo Nordisk and Eli Lilly went into shortage. But the shortage ended early last year.
• Novo Nordisk argues Hims & Hers has pressed on anyway, claiming personalization on a mass scale.
• The argument that the large number of people who were using the compounded versions during the shortage "now needed some sort of personalized formulation," is a "sham," John Kuckelman, Novo Nordisk's general counsel, told Axios.

What we're watching: Whether the Trump administration will take further action against Hims & Hers now that it has backed down on offering its version of the Wegovy pill.

• HHS spokesperson Andrew Nixon referred back to FDA's statement on Friday, when the agency said it would take "decisive steps" against compounded weight-loss drugs, without elaborating.
• HHS general counsel Mike Stuart told CNBC this week it is important to be "protecting the intellectual investments of companies that focus on cures for the American people, in comparison to companies that knock off cures and knock off solutions at the last minute."