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…$1 billion, $1.1 billion, $2.1 billion, $2.5 billion, and $5.3 billion. Such agreements can harm consumers in two ways: First, generic entry, and the accompanying discounts, would not be available…
…note 36). The preamble makes clear OIG’s intent that the discount safe harbor continue to protect discounts offered to other entities, including wholesalers, hospitals, physicians, pharmacies, and third-party payors in…
…certain prescription drugs and biological products (the Final Rule). In an effort to block the rule from going into effect on July 9, 2019, Merck, Eli Lilly, Amgen, and the…
…Inc. with a “retail location” in Rowland Heights, California, and I-Takashima, Inc., with a “retail location” in Irvine, California. Both were charged with violating the Federal Food, Drug, and Cosmetic…
…negotiated with a GPO acting on behalf of the healthcare services entity, is not prohibited wholesaling. Because a GPO “does not own drugs, ship drugs, warehouse drugs, handle drugs, or…
…the active ingredients in the drug are available in a lower cost OTC drug. Certain exceptions apply. Louisiana: Act 220 (enacted June 14, 2017, effective Aug. 1, 2017) Requires drug…
…statutes alleging that Defendants manufactured and dispensed prescription drugs that did not comply with certain federal laws requiring child resistant packaging. Specifically, according to Plaintiffs, Defendants violated the Poison Prevention…
…the Lanham Act. Sciele Pharma, Inc. v. Brookstone Pharmaceuticals, LLC. Plaintiff, Sciele Pharma, Inc., develops and sells branded prescription products, including the prenatal vitamins PRENATE ELETE and PRENATE DHA. …
…to hospital-based physicians, such as emergency department physicians). The exemption applies only to the prescribing of drugs or formulations covered under the X waiver, such as buprenorphine, and does not…
…Reg. 7,838 (Feb. 10, 2022); Dowell, Deborah, MD., et al, CDC Clinical Practice Guideline for Prescribing Opioids-United States, 2022, CDC. As explained more fully below, CDC concedes that states, insurers,…
…Congress was well aware of and intended when it passed the Medicare Prescription Drug, Improvement, and Modernization Act in 2003. In 2019, we blogged that the District Court found for…
…Under the Proposed Arrangement, patients would be given one complimentary trial supply of the medication, which would last from 1 to 10 weeks, depending on the patient’s weight, severity of…
…preempted states from establishing, or continuing in effect any requirements for the tracing of prescription drugs through the supply chain, that were inconsistent with, more stringent than, or in addition…
On June 2, 2008, First DataBank, a private publisher of prescription drug prices in the United States, announced a new proposed settlement in a class action suit alleging that the…
…medicine cabinet, the Drug Enforcement Administration (“DEA”) and its law enforcement partners are hosting thousands of local drop-off locations nationwide for proper disposal of unneeded medication on Saturday, October 29,…