Tagged as: legislation

President Trump’s Remarks on Lowering Drug Prices; Industry Reactions

On May 11, President Trump delivered remarks about his administration’s new plan to help lower drug prices.  The President blamed “soaring drug prices” on “everyone involved in the broken system,” including “the drug makers, insurance companies, distributors, pharmacy benefit managers, and many others,” such as “middlemen,” “special interests” as well…

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Four More States Consider Biosimilar Substitution Bills

As we reported last month, many state legislatures have passed or are considering biosimilar substitution bills.  Alaska, Connecticut, New Hampshire, and Vermont are the latest states to join this list. Last week, the Alaska legislature passed SB 32, entitled “Prescriptions for Biological Products,” which allows substitution of “an interchangeable biological…

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Wisconsin and West Virginia Pass Biosimilar Legislation

Last week, both Wisconsin and West Virginia passed legislation intended to facilitate the dispensing and substitution of biosimilar products.  Wisconsin and West Virginia join Michigan, which enacted House Bill 4472 on February 28, as the latest states to approve biosimilar access bills. On Wednesday, Wisconsin Governor Scott Walker signed Senate…

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Congress Mulls Passage of CREATES Act

The CREATES Act (Creating and Restoring Equal Access to Equivalent Samples Act), currently pending in Congress states as its aim to promote drug price competition by removing an impediment to the development and approval of lower cost generics or biosimilars. Currently some branded companies are using safety requirements, including restricted…

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Bipartisan PACED Act Introduced to Address Sovereign Immunity

Yesterday, Senator Tom Cotton (R-Arkansas) announced the introduction of proposed legislation, Preserving Access to Cost Effective Drugs Act, which would permit the Patent and Trademark Office and the International Trade Commission to review patents regardless of any claim of tribal sovereign immunity made as part of sham transactions.  The announcement explained…

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Oregon Passes Biosimilar Automatic Substitution Law

Last week, Oregon passed a law that allows pharmacists to automatically substitute a biosimilar with a prescribed biological product.  According to their new legislation, before a biosimilar can be automatically substituted, it must be approved by the FDA to be “interchangeable,” and the prescriber must not have forbidden the substitution.  Oregon…

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Legislation Tracker: PRICED Act Proposes to Shorten Biologic Exclusivity Period from 12 to 7 Years

A bill introduced in the House of Representatives yesterday proposes “[t]o amend the Public Health Service Act to shorten the exclusivity period for brand name biological products from 12 to 7 years.” Titled the “Price Relief, Innovation, and Competition for Essential Drugs Act,” or the “PRICED Act,” the proposed bill…

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Arizona Passes Biosimilar Automatic Substitution Law

Last month, the governor of Arizona signed a bill into law allowing pharmacists to automatically substitute a biosimilar for a reference branded biologic.  Arizona continues the recent trend of states enacting biosimilar automatic substitution laws, including, for example, New Jersey and Oregon. Under the new Arizona law, from December 31, 2016 onward,…

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