Morphine Regulation Is Changed Back After Plan To Avert Shortages Backfired
The Drug Enforcement Administration announced in December that it would switch from annual to quarterly quotas in an attempt to prevent shortages. However, STAT reports that the change had the opposite effect. The DEA is returning to annual quotas.
Stat:
DEA Reverses Course To Avert Morphine Shortages
The Drug Enforcement Administration is reversing a regulation that had been expected to create shortages of morphine and other opioid injectables, according to a DEA letter to drugmakers obtained by STAT. (Wilkerson, 5/1)
More on drug shortages and drug costs —
CIDRAP:
Scant Drug Ingredients Linked To US Generic-Drug Shortages In First 2 COVID Years
In the first 2 years of the COVID-19 pandemic, shortages of 11% of generic active pharmaceutical ingredients (APIs) made by global manufacturers—35% of them from larger facilities in India—were tied to generic-drug unavailability in the United States, according to a research letter posted this week in JAMA. (Van Beusekom, 5/1)
FiercePharma:
Emergent BioSolutions To Cut 300 Employees, Shutter 2 Facilities In Restructuring Launched Under New CEO
Emergent will reduce its current workforce by about 300 employees “across all areas of the company” and will eliminate about 85 job openings, the company said Wednesday. Simultaneously, the company will close its Baltimore-Bayview drug substance manufacturing facility and its Rockville drug product facility, both of which are located in Maryland. The firm’s sites in Winnipeg, Canada, and Lansing, Michigan, will conduct the bulk of operations going forward, while the company “actively explores strategic alternatives for its other sites throughout the year.” (Liu and Kansteiner, 5/1)
Reuters:
Healthcare And Drugmaker Groups Seek To Revive Challenge To US Drug-Pricing Law
Healthcare and drug industry groups on Wednesday urged a U.S. appeals court to revive their challenge to a law requiring manufacturers to negotiate the prices of some drugs with the U.S government's Medicare health insurance program or pay heavy penalties. Pharmaceutical Research and Manufacturers of America (PhRMA), the Global Colon Cancer Association and the National Infusion Center Association (NICA) sued the government last year, claiming the program, a signature initiative of Democratic President Joe Biden, violated the U.S. Constitution by giving too much power to federal regulators and imposing excessive fines on companies that refuse to participate. (Pierson, 5/1)
Bloomberg:
Novo Boosts Wegovy Shipments As Lilly Rivalry Pressures Prices
Novo Nordisk A/S is shipping more introductory doses of its blockbuster weight-loss drug Wegovy in the US as it grapples with supply constraints and competition from Eli Lilly & Co. Wegovy sales more than doubled to 9.38 billion kroner ($1.35 billion) in the first quarter, but the number fell short of analysts’ estimates due to pricing pressure. In a sign of investors’ focus on the obesity medicine, the stock declined even though quarterly profit surged and the company raised its forecast. (Kresge, 5/2)
In legal updates —
NBC News:
Johnson & Johnson To Pay $6.5 Billion To Resolve Nearly All Talc Ovarian Cancer Lawsuits In U.S.
Johnson & Johnson on Wednesday said it plans to pay $6.5 billion over 25 years to settle nearly all of the thousands of lawsuits in the U.S. claiming its talc-based products caused ovarian cancer, pending approval of the claimants. Those cases have for decades caused financial and public relations trouble for J&J, which contends that its now-discontinued talc baby powder and other talc products are safe for consumers. About 99% of the talc-related lawsuits filed against J&J and its subsidiaries stem from ovarian cancer. (Kim Constantino, 5/1)
Bloomberg:
Philips Sleep Apnea Deal Leaves Opening For Future Cancer Claims
Royal Philips NV’s $1.1 billion settlement of US lawsuits targeting 5.5 million recalled sleep-apnea devices resolves only current cases and doesn’t set aside monies for potential future cancer claims over the machines. The Dutch company has set aside €982 million ($1.1 billion) to fund a settlement of allegations that the faulty sleep-aiding machines pose a cancer risk because of deteriorating sound-dampening foam. The deal also provides funds to cover doctors’ bills as users monitor their future health. (Feeley and Koc, 5/2)
