The Biden administration’s efforts to fend off legal challenges from the pharmaceutical industry battling Medicare drug price negotiations has drawn reinforcements from officials and academics defending the program.

Former government officials, legal and economic scholars, and patient advocacy groups have become “friends of the court” in lawsuits by pharmaceutical giants and industry groups fighting the constitutionality of the Medicare Drug Price Negotiation Program. The plan, which is considered one of President Joe Biden’s signature health initiatives under the Inflation Reduction Act, is expected to slash the costs of 10 Medicare Part D drugs beginning in 2026.

The pharmaceutical industry has yet to win a court decision, and has seen several amicus briefs filed in favor of the government. Though the filers aren’t considered parties in the suits, they provide advocate or expert perspective that could factor in or influence the courts’ decisions.

“When you start seeing an amicus brief or multiple amicus briefs filed over a particular case, that kind of clues you into the fact that this might be an important one that you really want to focus on,” said Tom Pryor, a staff attorney with the Public Health Law Center at the Mitchell Hamline School of Law, who has analyzed and drafted various briefs.

Most amicus briefs are also filed in the Supreme Court and federal courts of appeals, said Lawrence Ebner, executive vice president and general counsel of the Atlantic Legal Foundation, a nonprofit, free-enterprise advocacy organization that is a frequent filer of amicus briefs.

“District court amicus briefs are becoming more common,” said Ebner, who is also a fellow of the American Academy of Appellate Lawyers.

Among the seven pending drug pricing trial court cases, over a dozen amicus briefs support the Department of Health and Human Services, and at least two are in favor of the pharmaceutical industry.

Lots of Claims

The Department of Justice, which represents the Medicare agency, has been wrestling with a wide spectrum of claims from the pharmaceutical industry. The plaintiffs allege the program violates compelled speech under the First Amendment, the Fifth Amendment takings clause and due process, and excessive fines under the Eighth Amendment. Plaintiffs also claim Congress delegated too much power to Medicare to administer the program.

One case so far has been decided on the merits. Chief Judge Colm F. Connolly of the US District Court for the District of Delaware in March ruled that AstraZeneca PLC‘s due process claims failed “as a matter of law,” and the manufacturer had not “identified a property interest protected by the Constitution that is put in jeopardy by the Program.”

Though the decision only applied to AstraZeneca, the ruling referenced key cases that were also cited by amicus briefs in other drug pricing suits.

Some of the cases included: Clapper v. Amnesty Int’ USA (2013) to support that “a plaintiff cannot manufacture standing merely by inflicting harm on [itself] based on [its] fears of hypothetical future harm that is not certainly impending"; Coyne-Delany Co. v. Cap. Dev. Bd (7th Cir. 1980) to cite “no one has a ‘right’ to sell to the government that which the government does not wish to buy"; and Perkins v. Lukens Steel Co (1940), which ruled “the Government enjoys the unrestricted power to produce its own supplies, to determine those with whom it will deal, and to fix the terms and conditions upon which it will make needed purchases.”

Amicus briefs have also tackled a primary argument among the lawsuits, which is that the program violates the Fifth Amendment takings clause because it seizes their property without paying just compensation and forces them to sell their property at a government-dictated price.

“These cases are creative and I give some kind of credit—like in a backhanded way—to the very high-paid and very smart lawyers representing these companies,” said Christopher Morten, an associate clinical professor of law at Columbia Law School who specializes in patent law and is a scholar in several amicus briefs.

“But they had to bend over backwards to come up with constitutional arguments against what is a price negotiation procedure. For decades, courts have held that price negotiation and price controls are constitutional. If a court sides with drug companies on these constitutional challenges, I think there’s profound harm that will flow,” Morten said.

Nationally recognized health-care and Medicare experts, including a former administrator for the Centers for Medicare & Medicaid Services, have also explained how the price-setting program is consistent with the government’s power.

Legal scholars also point out how industry arguments have been rejected by other courts.

The First Amendment claim, for example, “hasn’t been adopted or accepted in the past,” said David Schulz, director of the Media Freedom & Information Access Clinic at Yale Law School.

“If the courts adopted that reading of the First Amendment, it would have a tremendously adverse impact and could subject a whole host of regulations to First Amendment challenges,” he said.

Judge Zahid N. Quraishi of the US District Court for the District of New Jersey was skeptical of the First Amendment claim during a March oral argument—pressing the manufacturers on what makes the price-setting agreement “unique.”

“What’s your response to the fact they said you can say whatever you want?,” he asked the drugmakers. “Nobody is compelling you to make any statement that this is fair or that you agree with it or that you even like it.”

Quraishi also pressed the government on why there needs to be disclaimer in the contract template.

Pharma Support

Amici in favor of the industry include the Biosimilars Forum and Fresenius Kabi USA. While their filings didn’t focus on legal arguments as much, they pressed on concerns about the program’s consequences on drug innovation.

The Inflation Reduction Act “threatens to squeeze out competition from biosimilars,” the Biosimilars Forum said in its brief. “When a product is selected for price controls under the IRA, the statute requires CMS to reduce the product’s price by at least 25 to 60 percent.”

Fresenius Kabi, a health-care company that specializes in bringing affordable medicines to patients with critical and chronic conditions, also called attention to taxes companies will face if they decline to participate in the program or don’t comply with the maximum fair price ultimately set by Medicare. The manufacturer will be required to pay taxes that start at 65% of the US sales of a product and the fines would increase by 10% every quarter, with a maximum of 95%.

Manufacturers facing less support through amicus briefs could also influence a district court judge’s decision in the case.

“Generally,” Ebner said, “because far fewer amicus briefs are filed at the district court level, there is a better chance that an amicus brief will get read by a district judge and have impact on legal rulings.”

“A lot of work goes into a well-written and persuasive amicus brief,” he said.

The pharmaceutical industry, though, has signaled it intends to take its cases to the nation’s top court, which is expected to open the door to another slew of briefs filed at the appellate and Supreme Court level.