On September 25, 2018, the House of Representative passed the “Patient Right to Know Drug Prices Act” (S.2554). As we previously reported, the Senate passed the bill on September 19, 2018. The bill includes amendments to the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (“MMA”) that require patent…
Yesterday, the Senate overwhelmingly (98-2) passed the “Patient Right to Know Drug Prices Act” (S.2554), which includes amendments to the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (“MMA”) that require patent litigation settlements between a Reference Product Sponsor and a biosimilar applicant under section 351(k) to be submitted…
On July 23, 2018, Congressman John Sarbanes (D-Md.) introduced a bipartisan bill, the Biosimilars Competition Act of 2018, meant to curb “pay-for-delay” agreements entered into by biologic and biosimilar drug manufacturers. According to Congressman Sarbanes, the purpose of the bill is to help lower the cost of prescription drugs by affirmatively giving…
Last month we reported that Vermont, Connecticut, New Hampshire, and Alaska were in the process of considering biosimilar substitution bills. Vermont and Connecticut recently enacted their respective bills. On May 30, Vermont Governor Phil Scott signed bill S.92 into law as Act No. 193. The Act directs pharmacists to dispense…
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…
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…
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…
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…
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…
After a committee hearing on the price of rheumatoid arthritis drugs last week, Senator Susan Collins (R-ME) announced that she is working on a bill designed to lower drug costs. According to Bloomberg Law, the aim of the legislation would be to restrict “evergreening,” described as “the practice of extending…