Some E-Cigarettes Get FDA OK, Larger-Brand Approvals Pending
The approvals were for several tobacco-flavored products, on the basis they may work as an alternative to traditional cigarettes. Decisions on bigger brands, plus menthol-flavored items are still pending. Separately, the AP reports on another Alzheimer's drug approval process.
CNN:
The FDA Authorizes More E-Cigarette Products, But There's Still No Ruling On Menthol And Other Kid-Friendly Nicotine Products
The US Food and Drug Administration gave the official green light Thursday to several tobacco-flavored e-cigarette products from Logic Technology Development LLC. The FDA said it is also "close" to additional decisions about products that make up a larger share of the market. ... The FDA said Thursday that the tobacco-flavored Logic Technology products probably benefit adult smokers, serving as an alternative to traditional cigarettes. The likely benefit, the agency said, outweighs the risk that young people would start using them, provided that the company follows requirements to reduce access and exposure to them among youth. (Christensen, 3/24)
The Washington Post:
FDA Permits Another E-Cigarette, Pledges Decisions Soon On Big Brands
In announcing the decision on Logic, FDA Commissioner Robert M. Califf said in a statement that the agency’s career scientists balanced the risks and benefits of the e-cigarettes. He said he was confident the FDA staff was using “the best available evidence with the most robust methods to ensure that products that continue to be marketed are appropriate for the protection of the public health.” (McGinley. 3/24)
In other news from the FDA —
AP:
Pressured By Patients, FDA Reviews ALS Drug With Modest Data
When patients are battling a terminal illness and want access to an experimental drug, how much evidence that it works should regulators require before approval? That’s the question behind many of the Food and Drug Administration’s toughest decisions, including last year’s controversial approval of Aduhelm. Many experts — including the agency’s own outside advisers — say that Alzheimer’s drug is unlikely to help patients. (Perrone, 3/24)
In other pharmaceutical news —
Stat:
Despite Competition, U.S. Cancer Drug Prices Rose Even As They Fell In Germany And Switzerland
Even as prices rose substantially in the U.S. over a recent 12-year period, a new analysis found that prices for the same cancer drugs either decreased or did not exceed inflation in Germany or Switzerland, where governments negotiate pricing with manufacturers. After examining price changes for medicines approved to combat a dozen different forms of cancer between 2009 and 2020, researchers found that — with one exception — the median price for all of the drugs rose 6% in the U.S. two years after product launches. And prices climbed 15% by four years after a medication became available, despite a growing number of competitive treatments. (Silverman, 3/24)
Stat:
Sun Pharmaceuticals To Pay $485M To Settle Claims On Overpayments
On the eve of a trial, Sun Pharmaceuticals has agreed in principle to pay $485 million to settle lawsuits that alleged its Ranbaxy Pharmaceuticals unit misled regulators in order to win exclusive approvals for generic medicines, which delayed competition and forced consumers to overpay for the drugs. The settlement was disclosed in a filing with the Bombay Stock Exchange. The lawsuits stemmed from a scandal that erupted more than a decade ago after U.S. authorities learned Ranbaxy, which was one of the biggest generic makers, falsified testing data and manufactured drugs that failed to meet safety standards. In 2013, the company, which is now part of Sun, pleaded guilty to felony charges and paid a $150 million penalty, as well as $350 million to settle civil claims. (Silverman, 3/24)
The Boston Globe:
US Attorney’s Office Reaches Agreement With Trial Court Over Disability Discrimination Allegations
US Attorney Rachael Rollins announced Thursday that an agreement has been reached with the Massachusetts Trial Court resolving allegations that its drug court violated the Americans with Disabilities Act by discriminating against people with Opioid Use Disorder. A complaint to the US Attorney’s Office claimed the Trial Court discriminated against people taking medication for Opioid Use Disorder when they were ordered to stop taking their medication without medical assessment, the office said in a statement. The drug court personnel also required or pressured participants to take Vivitrol as a treatment. (Mercado, 3/24)
Also —
FiercePharma:
As Russian Invasion Persists, Roche, Teva, Novartis, Merck And More Make Renewed Push To Support Besieged Ukraine
As Ukraine holds the line against the Russian invasion, pharma majors are making a renewed push to adjust operations in the region and supply the besieged country with critical meds and tools. Swiss pharma Roche on Wednesday said it was donating additional drugs and diagnostics to Ukraine, building on 150,000 packs of antibiotics the company previously pledged. It says it’s adding to its commitment another 4,600 packs of specialized medicines for influenza, rheumatoid arthritis, spinal muscular atrophy and various cancers. (Kansteiner, 3/23)
