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…ratios. Furthermore, although our analysis is preliminary, we find that 180-day exclusivity does not appear to lower long-run generic-to-brand price ratios or increase long-run generic penetration. Hence, any effect of…
…v. Sandoval, No. 2:17-cv-02315 (D. Nev. Jun. 28, 2018). First, the Emergency Regulation, LCB File No. R042-18 (effective May 31, 2018), amends Chapter 439 of the Nevada Administrative Code to…
…approval of generic drugs for reference products that lack significant competition, a CGT designation offers applicants benefits, like enhanced communications with FDA officials, expedited ANDA review, and potential eligibility for…
…to Dismiss at 9, PhRMA v. Brown, No. 2:17-cv-02573 (E.D. Cal. Jan. 26, 2018) [hereinafter Memorandum]; see also Ex Parte Young, 209 U.S. 123, 157 (1908). In the present matter,…
…advancing the effective date to January 1, 2019. However, on November 2, 2018, the Court issued an order declining to stay the case, reasoning that HHS cannot guarantee that the…
…reform legislation. The proposed options include lifestyle taxes (e.g., alcohol excise taxes), reductions in subsidies and incentives related to health care (e.g., repealing the itemized deduction for medical expenses), and,…
On September 18-20, Informa Connect will hold its annual #MDRPSummit in Chicago (and via livestream) to discuss the complex, ever-evolving laws and regulations in the government pricing and price reporting…
…military’s health care program serving active duty service members, retirees, their families, survivors and certain former spouses. If the legislation is enacted, then the TRICARE retail pharmacy rebate program would…
Colorado and Florida have joined Vermont in the list of states seeking to combat high prescription drug prices by establishing programs to import drugs from Canada. On April 29, 2019,…
…340B drug payment methodology under the final rule. See Am. Hosp. Ass’n v. Azar, No. 18-2084, 2, 22 (D.D.C. May 6, 2019). As background, under the Social Security Act, CMS…
…whether to exclude pharmaceutical manufacturers, manufacturers and distributors of durable medical equipment (DME), pharmacy benefit managers, wholesalers, and distributors from the definition of “VBE participant,” or, alternatively, to impose a…
On Friday, July 24, Donald Trump signed three Executive Orders addressing the high prices of prescription drugs, and threatened to sign a fourth if drug manufacturers do not put forward…
…for testing. Additionally, sales by an outsourcing facility to a wholesale distributor, repackager, or relabeler that, in turn, sells or transfers the drug are clearly prohibited because the drug is…
…comprised of the basic rebate and the additional rebate, which is a penalty imposed for raising a price at a rate greater than the rate of inflation. Without a cap,…
…calls on the Department of Justice, the Federal Trade Commission, the Agriculture Department, the Treasury Department, the Department of Commerce, the Department of Health and Human Services (DHHS), and other…