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New Legislation › Generic Drugs › Prescription Drugs

Brownstein Hyatt Farber Schreck

Reflections on the Inflation Reduction Act’s Pill Penalty

Brownstein Hyatt Farber Schreck on

The Medicare drug price negotiation provision in the 2022 Inflation Reduction Act treats small molecule drugs and biological products differently. For small molecules, drug price negotiations can start seven years after Food...more

WilmerHale

Unprecedented State Law on Pharmaceutical “Reverse Payments” Goes Into Effect

WilmerHale on

A new California law, Preserving Access to Affordable Drugs, AB-824 (the Act), which is aimed at curbing reverse-payment patent settlements, took effect on January 1. The Act codifies a presumption that any transfer of value...more

Wilson Sonsini Goodrich & Rosati

Sitting Here on Capitol Hill: Congressional Developments on Life Science and Consumer Product Issues - July 2019

Wilson Sonsini Goodrich & Rosati on

Legislation - Biologics: Senate Health Committee Passes Bipartisan Legislation to Lower Health Care Costs - During the last week of June, the Senate Health, Education, Labor, and Pensions (HELP) Committee approved...more

Hogan Lovells

There'll Be Some Changes Made: President Signs Prescription Drug and Biologic User Fee Reauthorization Act

Hogan Lovells on

On August 18, 2017, President Trump signed into law the FDA Reauthorization Act (FDARA). FDARA reauthorizes user fees paid to FDA to support regulatory review of innovator drugs and biologics, medical devices, generic drugs,...more

Mintz - Health Care Viewpoints

New State Substitution Laws, and a Busy Spring for Biosimilars

Mintz - Health Care Viewpoints on

We recently updated our chart that tracks state biosimilar substitution laws to include new laws in Iowa and Montana. These new laws bring the total number of states with biosimilar substitution laws to 27, plus Puerto Rico....more

Mintz - ML Strategies

Health Care Update - November 2015

Mintz - ML Strategies on

Ways & Means Leadership Changes – Health Policy Implications Looming: As Congress pushes forward with a two-year budget deal, and new Speaker Paul Ryan begins his tenure as the top Republican in the House of...more

Mintz - Health Care Viewpoints

California Becomes Latest State to Pass Biosimilar Substitution Law

Mintz - Health Care Viewpoints on

On October 6th, California’s governor signed Senate Bill 671, which permits pharmacists to substitute an interchangeable biological product for a prescribed biological product. The California legislature had attempted to pass...more

Faegre Drinker Biddle & Reath LLP

Alabama Governor Signs Bill Quashing Innovator Liability Claims

Faegre Drinker Biddle & Reath LLP on

On May 1, 2015, Alabama Governor Robert Bentley signed SB80, which expressly bars liability claims against manufacturers that did not design or make the product that a plaintiff actually ingested or used. While at first...more

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