Public Citizen filed a citizen petition Tuesday asking the FDA to add a boxed warning to the label of Amgen Inc.'s Prolia (denosumab) to call more attention to an increased risk of spinal fractures when patients stop taking the osteoporosis drug. Administered by injection every six months, Prolia was first approved by the FDA in 2010 to treat postmenopausal women with osteoporosis at high risk for fracture. Its label has since been expanded to include men. In its petition, Public Citizen cited a growing body of evidence showing an increased risk of multiple vertebral fractures in the spine as soon as seven months after a patient's last dose. The watchdog group referenced a study that described 24 patients who collectively experienced 112 new spinal fractures after stopping the drug. Prolia's current label notes the risk, but Public Citizen said it's buried and it should be replaced with a boxed warning. The petition also asked the FDA to require Amgen to send letters to doctors and develop updated patient brochures to warn of the risk if the drug is stopped or a dose is missed.

The Biotechnology Innovation Organization (BIO) used its response to an FDA information collection request on drug safety labeling changes as an opportunity to push its case for doing away with paper labeling in a society that's living more and more online. The agency's estimate of the burden of the information collection is incomplete, BIO said, as it focuses on e-labeling, ignoring that sponsors spend about 20 to 25 hours updating paper labeling each time a change is made. When prescribing information is revised, paper labeling can cause a delay in making the new safety information available because of existing supply chain inventory of the product with the old labeling. The industry group also noted the waste when paper labels are required for more than 4.5 billion prescriptions in the U.S. each year. "In this modern era of ubiquitous information technology and real-time communication, this paper-based approach for dissemination of important new medical information is wasteful, uneconomical, inefficient and potentially harmful to [health care providers], patients and caregivers," BIO said. "More importantly, the continued reliance on paper and the delays associated with paper labeling is contrary to a regulatory system that acts in the best interest of patients."

The U.S. Supreme Court Monday denied cert to Saint Regis Mohawk Tribe v. Mylan NV, leaving standing last year's Federal Circuit decision that tribal sovereign immunity is not a protection against inter partes reviews. The case stemmed from a deal in which Dublin-based Allergan plc transferred six patents protecting its blockbuster dry eye drug Restasis (cyclosporine) to the New York tribe and then licensed them back in an effort to protect the patents from IPR challenges. Several generic drug companies were already challenging the patents through the IPR process when the licensing agreement was signed. Much of the analysis and case law the three-judge Federal Circuit panel cited in reaching its unanimous decision applied to sovereign immunity in general – not just tribal sovereign immunity. The panel recognized that the same questions could be raised about patents held by state universities, which currently enjoy immunity from IPRs. Rather than addressing that issue, "we leave for another day the question of whether there is any reason to treat state sovereign immunity differently," the appellate court said. The Supreme Court's refusal to hear the case could open the door even wider to challenges of state immunity from IPRs. (See BioWorld, July 24, 2019.)

Two years after inspecting an Irvine, Calif.-based facility of a compounding pharmacy that had positioned itself as an alternative to high-priced drugs, the FDA slapped Imprimisrx CA Inc. with a warning letter that was posted this week. The March 2017 inspection was instigated by an adverse event in which a patient reportedly experienced cardiac arrest and died after an infusion of intravenous curcumin containing PEG 40 castor oil compounded by Imprimisrx. During the inspection, the FDA noted that some of the drugs the company was producing weren't eligible for compounding because they involved substances that were not the subject of an applicable U.S. Pharmacopeia or National Formulary monograph, not components of an FDA-approved drug and not on the 503A bulks list. In addition, the warning letter cited "serious deficiencies" in the company's practices for producing sterile drug products, other product quality issues and inadequate labeling that put patients at risk. In 2015, Imprimisrx's parent company, San Diego-based Imprimis Pharmaceuticals Inc. (now known as Harrow Health Inc.), garnered national attention when it offered a 99-cent compounded alternative to Daraprim (pyrimethamine) after Turing Pharmaceuticals LLC hiked the price of the decades-old toxoplasmosis drug from $13.50 per tablet to $750 a tablet. (See BioWorld Today, Oct. 27, 2015.)

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