Morning RX: June 6, 2023

Merck Sues Biden Administration Over Medicare-Negotiation Program

Pharmaceutical company Merck filed a lawsuit against the Biden administration on Tuesday over legislation that will allow Medicare to negotiate prices with drugmakers, the New York Times reported. The Medicare-negotiation program, a provision of the Inflation Reduction Act, is set to go into effect beginning in 2026. Although only some drugs will be open to negotiation after they have been on the market for a certain period of time, Merck claims in its lawsuit that the program is unconstitutional. The company says it will be coerced into providing its products for prices set by the government, violating a clause in the fifth amendment. The government plans to unveil the first 10 drugs subject to negotiation under the program in September.

FDA to Allow Import of Cancer Drugs From China

Amid an ongoing shortage of vital cancer medications, the FDA will allow the import of certain drugs from China, according to USA Today. Chinese drug manufacturer Qilu Pharmaceuticals will begin importing cisplatin, an injectable chemotherapy treatment that has been in short supply since February. Apotex Corporation, a Toronto-based pharmaceutical company, will distribute the drug to the US in 50-milligram vials.

"In these situations, we very carefully assess product quality and require companies to take certain measures to ensure the products are safe for patients," said FDA Commissioner Robert Califf in a post on social media. "The public should rest assured that we will continue all efforts within our authority to help the industry that manufactures and distributes these drugs meet all patient needs for the oncology drugs impacted by shortages."

Apotex will begin shipping the drugs on Tuesday, with patients expected to be able to begin treatment later this week, said company spokesman Jordan Berman. The FDA has said that it expects the shortage of cancer drugs to last at least until sometime later this month.

GSK Receives FDA File Acceptance for Endometrial Cancer Drug

A supplemental Biologics License Application for GSK’s Jemperli (dostarlimab) was accepted by the FDA, the pharmaceutical company announced Tuesday. In combination with chemotherapy, Jemperli is used to treat adult patients with certain types of endometrial cancer. The license application was based off data from interim analysis results from Part 1 of a phase 3 trial.The trial demonstrated a statistically significant and clinically meaningful benefit in patients treated with dostarlimab and carboplatin-paclitaxel. The application was granted priority review by the FDA and was assigned a Prescription Drug User Fee Act action date of September 23, 2023.