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…as “[a]n end product manufactured in the United Sates if–(i) [t]he cost of its components mined, produced, or manufactured in the United States exceeds 50 percent of the cost of…
…and cost and increasing the predictability of going from concept to commercialization to address the valley of death.” The striking phrase “valley of death,” is generally understood to refer to…
…provisions that relate most closely to drug cost reduction. CMS is accepting public comments on the Proposed Rule until January 25, 2019. Providing Plan Flexibility to Manage Protected Classes Current…
…4205 and 80 comments on the draft guidance, and considered all those comments when drafting the proposed rules. FDA estimates that the initial mean cost of complying with the proposed…
…possible, reaching more eligible patients, and providing care that is more comprehensive. Under the Social Security Act, CMS must set reimbursement rates for certain separately payable drugs under the Medicare…
…the Commerce Clause by directly regulating interstate commerce. The Commerce Clause empowers Congress to regulate commerce “among the several states,” and thereby prohibits states from discriminating against or unduly burdening…
…the Committee within 30 days of the completion of the report by the IOM. Biological Products. – The Committee commends the FDA for issuing draft guidance to address the mixing,…
…here.) PhRMA, BIO, and GPhA argued that the Alameda Ordinance is a per se violation of the Commerce Clause of the U.S. Constitution, and, in particular, the dormant Commerce Clause,…
…that a covered entity cannot profit from the communication. If the covered entity receives a financial incentive beyond its cost, it must obtain the patient’s authorization. Because, as the complaint…
…covered entities for compliance with the orphan drug exclusion (though it does authorize manufacturer audits of compliance with other 340B Program requirements). The proposed regulation does refer to “government-approved manufacturer…
…of this section or specific intent to commit a violation of this section.” In addition, a potentially significant change for FDA-regulated companies, is the insertion of FDC Act § 301…
…nonprescription status. However, opponents argue that out-of-pocket costs for many consumers could rise if third-party payers elect not to cover BTC drugs. The GAO report also goes on to comment…
…committee dedicated to the review of ETASU. In the interim, Kaiser suggests that advisory committees (with a health care provider member) reviewing drugs that will likely receive ETASU also have…
…of such prescriptions drugs. This term is defined as a price increase that is “excessive and not justified” by the manufacturing cost or costs associated with expanding access to the…
…the Commerce Clause, and the Fourteenth Amendment’s Due Process Clause. The state sought to dismiss the lawsuit, but Judge England found that PhRMA’s “non-conclusory” allegations could proceed. Colorado As we…