As expected, the court challenges are rolling in to stop the Centers for Medicare and Medicaid Services (CMS) from implementing a most-favored nation (MFN) pricing model for some Part B drugs.

The Biotechnology Innovation Organization (BIO) and Pharmaceutical Research and Manufacturers of America (PhRMA) signed on to two separate lawsuits challenging the seven-year model CMS plans to launch Jan. 1 for a cohort of 50 single-source drugs and biologics with the highest Medicare Part B spending.

Rather than the current U.S. average sales price (ASP) plus 6% add-on, the model calls for providers to be reimbursed for the selected drugs with a payment that phases in the lowest price of the drug in other similar countries by blending it with the current ASP and a flat add-on per dose that will be the same for each drug in the model.

BIO joined the California Life Sciences Association and BIOCOM California in filing suit Dec. 4 in the U.S. District Court for the Northern District of California. Their complaint outlines several legal arguments, including the Trump administration’s attempt to implement the model without prior notice or opportunity for public comment.

Instead of going through the regular rulemaking process, the administration issued the model as an interim final rule – a process that allows a rule to be implemented at the same time it’s released for comment.

Under the Administrative Procedure Act, agencies need to have good cause to issue an interim final rule in place of a proposed rule, which requires a public comment period before the rule can be finalized and implemented.

BIO said its complaint argues that the U.S. Department of Health and Human Services (HHS) “lacks the authority to make sweeping changes to statutory Medicare rules through administrative fiat.” In addition, the suit cites HHS’ acknowledgement, in the rule itself, that it couldn’t estimate the impact the model would have on patients and providers.

The PhRMA complaint, which was filed the same day in the U.S. District Court for the District of Maryland, makes similar arguments in challenging the way the model is being implemented. “By proceeding with an interim final rule, the administration has … deprived the American public of their right to provide input on these drastic changes before they are implemented,” said James Stansel, PhRMA executive vice president and general counsel.

The Association of Community Cancer Centers (ACCC), Global Colon Cancer Association and National Infusion Center Association (NICA) joined PhRMA in the suit, expressing concern about the impact it could have on patients.

“The rule will restrict and disrupt access to care, force patients to switch from a drug that effectively manages disease to a less-effective drug for reasons unrelated to health or safety, and impair providers’ ability to provide adequate care, thereby disrupting the delicate disease management equilibrium patients have worked so hard to achieve,” NICA CEO Brian Nyquist said.

“This will result in adverse health outcomes, reduced quality of life, increased physical and emotional burdens of disease, and increased cost to both patients and Medicare,” he added.

ACCC Executive Director Christian Downs noted that the rule would have “a disproportionate impact on smaller hospitals and practices, which are already struggling due to the COVID-19 pandemic, and force them to curtail services and access to ensure their viability.”

FDA, industry prepare for vaccine

Ahead of its Dec. 10 advisory committee meeting on the Pfizer Inc./Biontech SE COVID-19 vaccine, the FDA granted a waiver so James Hildreth, the president and CEO of Meharry Medical College, can serve as a temporary voting member of the Vaccines and Related Products Advisory Committee.

The waiver was necessary because the college will receive between $500,000 and $750,000 for conducting a clinical trial for an undisclosed COVID-19 vaccine being developed under Operation Warp Speed. Hildreth is not the principal investigator for the trial, but he has expressed an interest in participating in the trial, according to the FDA.

Although the FDA cautions panelists against talking with the media during meetings, Hildreth was interviewed Dec. 5 on NBC News’ Weekend Today about the upcoming adcom on Pfizer’s request for an emergency use authorization (EUA) for the vaccine.

According to the NBC transcript of that interview, Hildreth indicated the FDA could issue the EUA as soon as the adcom votes. If that happens, the vaccine would be available Friday, he said.

Meanwhile, industry is doing everything it can to build public confidence in the COVID-19 vaccines being developed. BIO launched a website Dec. 4 in English and Spanish as an educational tool linking providers and the public to scientific and evidenced-based information about the vaccine development process.

Using a question-and-answer format, COVIDvaccinefacts.org covers topics such as vaccine safety, efficacy, availability and affordability. BIO is promoting the vaccine website through a series of tweets.

In another educational effort, a recent BIO podcast featured the CDC’s Nancy Messonnier, who discussed the safety and efficacy of the vaccines.

FDA updates trial guidance

The FDA updated its March guidance on conducting clinical trials in the time of COVID-19.

The Dec. 4 update includes a new question and answer regarding the disposal of unused investigational drug when a study participant cannot return it to the trial site. The guidance discusses alternative procedures for disposing of the investigational product provided they do not expose humans to risks.

Labeling changes for diabetes drugs

The FDA approved labeling changes stating that three Merck & Co. Inc. diabetes drugs are not proven to improve blood sugar control in 10- to 17-year-olds with type 2 diabetes.

The labeling changes for Januvia (sitagliptin), Janumet (sitagliptin and metformin hydrochloride) and Janumet XR are based on results from three double-blind, placebo-controlled studies that showed young people taking sitagliptin didn’t have a significant decrease in hemoglobin A1c as those taking placebo.

Approved to improve blood sugar control in adults with type 2 diabetes, sitagliptin hasn’t been studied in pediatric patients younger than 10 with type 2 diabetes.