On Friday, a federal judge rejected the request made by business associations to pause Medicare’s new program for negotiating drug prices, as several lawsuits disputing its legality continue to progress through the legal system.
Judge Michael J. Newman, who was appointed by Trump, has made a ruling in Ohio’s Southern District that allows the Biden administration to move forward with negotiating drug prices for 10 medications. The drug companies involved in the first round of negotiations, chosen by CMS, have until October 1st to agree to the talks.
According to Newman’s opinion, the Court is not persuaded that providing preliminary injunctive relief to the Plaintiffs will safeguard them from impending and irreparable damage. The potential financial harm, which alone is not enough to meet the requirements for a preliminary injunction, will only take place in the distant future.
The U.S. Chamber of Commerce, along with local and state chambers, requested an injunction and is currently evaluating the ruling.
Newman requested that the Chamber, which opposed the program along with state and local chambers of commerce, update its complaint to specify the member companies of these groups that would be impacted by the program. He also inquired if AbbVie, the company mentioned in the lawsuit by the Chamber, is the actual manufacturer of Imbruvica, a cancer medication chosen for negotiation.
The lawyers of the Justice Department asserted that Pharmacyclics, a subsidiary fully owned by AbbVie, is the subject in question.
The main producer of the medication.
The company that holds the FDA approval will be responsible for negotiating with CMS.
Newman refused the DOJ’s request to dismiss in order to allow the court to address his concerns, but the government may still file again.
On Friday evening, Abbvie issued a statement addressing the ruling and disclosed its intention to take part in the negotiations.
“Irrespective of the fact that it does not constitute a valid negotiation, AbbVie will still take part in the procedure set forth by CMS. Our involvement does not alter or relinquish our stance that the ‘negotiation’ initiative established by the [Inflation Reduction Act] violates the constitution, is involuntary, and jeopardizes the progress of scientific innovation for patients in the United States and globally,” stated AbbVie in an email.
Four other drugmakers — Merck, Boehringer Ingelheim, AstraZeneca and Bristol Myers Squibb — have publicly said they will participate in negotiations. Companies are not required to announce their decision to opt into the program.
The Chamber was the sole party out of six pharmaceutical companies and one major industry organization to file a lawsuit seeking to halt the implementation of the drug pricing program. They had requested a decision from the court by October 1, the deadline for drugmakers to either agree to negotiate prices or face consequences such as pulling their products from Medicare or paying high excise taxes, both of which would be expensive for most drugmakers.
2015 Clean Water Rule is an illegal federal land grab
The legal action, supported by chambers of commerce at the state and local levels, asserts that the 2015 Clean Water Rule is a violation of federal law in its attempt to seize land.Inflation Reduction Act
The program, a crucial part of the IRA, violates the First, Fifth, and Eighth amendments of the Constitution according to the chambers. They argue that it would require them to promote the government’s preferred opinions about fair prices, infringe on their right to due process, and impose excessive fines as disproportionate consequences for not adhering to CMS’ final price for certain drugs.
The Department of Justice responded in legal documents, stating that the Chamber and its members have not provided evidence of immediate harm caused by the program. They also argued that the plaintiffs were making assumptions about who may be affected by the negotiations, as the lawsuit was filed before CMS released its list on August 29 of the initial 10 drugs to be negotiated.
The Chamber’s right to bring its case was also questioned by government lawyers.
Six pharmaceutical companies and PhRMA, the leading advocacy organization for name-brand drugs, have initiated legal action in various federal district courts throughout the country. This seems to be a strategic move to prompt differing rulings and expedite the matter to the Supreme Court.
The next step is for the Chamber to submit a revised complaint by October 13th. The DOJ would then have until October 27th to refile their motion to dismiss.