Drugmakers Hit With Record $370 Million Fine For Price Gouging In UK
The U.K.'s antitrust regulator levied the fine after an investigation found an "egregious" scheme to boost drug prices and delay release of lower-cost versions. In particular, generic hydrocortisone tablets suffered a 10,000% price hike. Separately, controversial drug Aduhelm is back in the news.
Stat:
U.K. Issues Record Fine To Drug Makers For Price Gouging And Collusion
After a lengthy investigation, the U.K. antitrust regulator has fined several drug makers a record-setting $370 million for their role in an “egregious” scheme to significantly hike the cost of medicines and delay the sale of lower-cost versions. At issue was the cost of hydrocortisone tablets, which cost the U.K. government and taxpayers $110 million annually by 2016, up from roughly $700,000 in 2008. During that time, Auden Mckenzie and Actavis UK, which is now known as Accord UK, increased the price by more than 10,000%. For instance, the National Health Service paid $142 for a 20m pack in 2016, up from $1.48 in 2008. (Silverman, 7/15)
FiercePharma:
After 10,000% Price Hike, Pharma Companies Face $350M-Plus Fine In U.K.
The U.K.’s long-running investigation of the 10,000% price hike for generic hydrocortisone tablets has now yielded hefty fines for several drugmakers. After a years-long probe, the U.K.'s Competition and Markets Authority on Thursday handed down fines worth more than £260 million ($360 million) to more than 10 pharmaceutical companies. (Sagonowsky, 7/15)
In updates on Aduhelm —
Stat:
Panel Votes Unanimously That Alzheimer's Drug Doesn't Offer Benefits
A prominent panel of medical experts unanimously voted that there is no evidence to suggest the recently approved Alzheimer’s drug offers patients any health benefits beyond the usual care. The meeting, which was convened to review both clinical and cost effectiveness of the new drug, is the latest blow to Biogen (BIIB) and its efforts to win acceptance amid a firestorm of controversy over study data and its dealings with the Food and Drug Administration. (Silverman, 7/15)
The Boston Globe:
Mass General Brigham Unlikely To Recommend Alzheimer’s Drug To Patients On Blood Thinners - The Boston Globe
Mass General Brigham is unlikely to offer Biogen’s controversial new Alzheimer’s drug to patients taking blood thinners because of concerns about the risk of bleeding in the brain, according to two doctors helping to develop a policy on the medicine for the state’s largest health care provider. Dr. Teresa Gomez-Isla and Dr. Kirk Daffner, Alzheimer’s specialists at Massachusetts General Hospital and Brigham and Women’s Hospital, respectively, noted that patients on anticoagulant medications were excluded from clinical trials of the recently approved Aduhelm. The Cambridge biotech’s medicine was associated with “microhemorrhages,” or small amounts of bleeding, in the brains of some patients in the studies but usually didn’t cause serious problems. (Saltzman, 7/15)
In other pharmaceutical industry news —
AP:
Pfizer, Subsidiaries Agree To Pay $345M In EpiPen Settlement
Pfizer Inc. and two of its subsidiaries have agreed to pay $345 million under a proposed settlement to resolve lawsuits over EpiPen price hikes. In documents filed Thursday in federal court in Kansas City, Kansas, the New York-based Pfizer and its subsidiaries — Maryland-based Meridian Medical Technologies Inc. and Tennessee-based King Pharmaceuticals — asked the court to grant preliminary approval to the settlement, Kansas City’s NPR station KCUR-FM reported. (7/15)
Stat:
Expert Panel Votes Down Fibrogen's Anemia Pill Due To Safety Risks
A panel of outside experts convened by the Food and Drug Administration concluded Thursday that the risks of blood clots and other safety concerns tied to Fibrogen’s anemia pill were too high to support the drug’s approval for patients with chronic kidney disease. The FDA is not required to abide by the panel’s recommendations, but the lopsided votes against the Fibrogen drug called roxadustat — backed by strong concerns about its safety in vulnerable patients — makes it all but certain the drug will not reach the market without more data from additional clinical trials. (Feuerstein, 7/15)
FiercePharma:
Sprout's Female Libido Drug Addyi Back In FDA's Crosshairs Years After Controversial Approval
Sprout Pharmaceuticals' female libido drug Addyi has traveled a winding path through FDA gatekeepers, multiple M&A deals, marketing restrictions and more. With a possible new safety flag, the controversial medicine could be set for even more scrutiny. In a rundown of potential new safety concerns on approved products, the FDA flagged the Addyi for possible risks of drug hypersensitivity. The FDA said it is "evaluating the need for regulatory action." The latest chapter in Addyi's history comes after several relatively quiet years for the drug. (Sagonowsky, 7/14)
Fox Business:
Fat Burner, Growth Hormone Drugs Recalled Over Product Sterility Concerns
The Food and Drug Administration (FDA) has announced Innoveix Pharmaceuticals' voluntary recall of two medications over product sterility concerns. The prescribed injection drugs under the recall involve Sermorelin/ Ipamorelin 3mg and AOD-9604 3mg, meant to stimulate the release of growth hormones and help fight obesity through metabolism regulation. Consumers were advised not to use the products and seek a full refund. (Rivas, 7/15)
