News & Analysis as of

Generic Drugs Proposed Legislation

King & Spalding

House Committees Introduce Legislation Aimed at Improving Price Transparency and Lowering Health Care Costs for Patients

King & Spalding on

On September 8, 2023, Members of the House Energy and Commerce Committee, the Ways and Means Committee, and the Committee on Education and the Workforce introduced a health care package titled the Lower Costs, More...more

Holland & Knight LLP

Holland & Knight Health Dose: May 16, 2023

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. ...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Legislative Efforts to Remove Impediments to Biosimilar Approvals and Marketing

Biosimilars are becoming increasingly important in healthcare as they offer a lower-cost alternative to biologic drugs, which can be expensive for patients, governments, and insurers. These biologic medicines, which are...more

Goodwin

Year in Review: Top Legal Developments of 2021 Impacting Biosimilars

Goodwin on

As we close out another calendar year, we look back at the top legal developments of 2021 that could influence the market for biologics and biosimilars. There were many interesting decisions and other developments in district...more

Goodwin

Senate Judiciary Committee’s Antitrust Panel Discusses and Advances Proposed Generics and Biosimilars Bill

Goodwin on

On July 13, 2021, the Senate Judiciary Committee’s antitrust panel met to discuss biologic and biosimilar competition and its impact on drug prices. A group of senators, led by Senator Amy Klobuchar, are sponsors of a Senate...more

Zuckerman Spaeder LLP

Senate Tweaks Hatch-Waxman with Bill To Codify FDA’s “Active Moiety” Regulation

Zuckerman Spaeder LLP on

To clarify a long-running, hotly-litigated question regarding when a new drug qualifies for exclusive marketing rights intended to reward innovation, Congress has taken an important step toward amending the Federal Food,...more

Foley Hoag LLP - Medicaid and the Law

Senate Finance Committee Proposes Significant Drug Pricing Reforms in Medicaid

On July 25, 2019 the Senate Finance Committee voted to advance their long-awaited drug pricing package to the Senate floor (we anticipate a Floor vote sometime this Fall). The Prescription Drug Pricing Reduction Act (PDPRA)...more

Hogan Lovells

Online sale of pharmaceuticals in Russia remains prohibited and lawmakers are yet to pass the bill allowing online sales

Hogan Lovells on

Russian law currently prohibits the online sale of pharmaceuticals and requires that pharmaceuticals must be sold only in stationary pharmacies operated by a person holding a pharmaceutical licence....more

Polsinelli

Update on Pending Legislation: Three New Bills Have the Potential to Affect Generic Pharmaceutical Companies

Polsinelli on

In the first month of the 116th Congress, three bills have been introduced (or re-introduced) that have potential to impact generic pharmaceutical companies. ...more

Knobbe Martens

Proposed Legislation: The Hatch-Waxman Integrity Act

Knobbe Martens on

Senator Orrin Hatch (R-UT) recently introduced a bill titled the “Hatch-Waxman Integrity Act of 2018” (HWIA). Sen. Hatch suggests that the HWIA will (i) “restore the careful balance the Hatch-Waxman Act struck to incentivize...more

Fish & Richardson

Senator Hatch: Choose IPR or an Abbreviated Regulatory Pathway, But Not Both

Fish & Richardson on

Last week, Senator Orrin Hatch of Utah introduced the “Hatch-Waxman Integrity Act of 2018,” which seeks “to restore the careful balance the Hatch-Waxman Act struck to incentivize generic drug development.” ...more

Foley & Lardner LLP

Health Care Policy Newsletter - June 2018 pt 2

Foley & Lardner LLP on

Foley & Lardner LLP’s (“Foley”) Bipartisan Public Policy Team is pleased to share our “Public Policy Weekly* Health Care Newsletter” in which we compile the latest Health care policy news and legislation. *Please note that we...more

Foley & Lardner LLP

Proposed Legislation Would Require Choice Between ANDA Litigation Or AIA Challenges

Foley & Lardner LLP on

On June 13, 2018, Sen. Hatch (R-Utah) introduced an amendment that would require generic ANDA filers to choose between litigating validity in Hatch-Waxman district court litigation or an AIA challenge (IPR or PGR), and on...more

Akin Gump Strauss Hauer & Feld LLP

Trump Administration: 2017 Recap and 2018 Outlook

On January 20, 2017, businessman Donald J. Trump was sworn in as the 45th President of the United States following a contentious and unconventional 2016 presidential election. Republicans also successfully maintained control...more

Foley & Lardner LLP

Senate Judiciary Introduces CREATES Act To Expedite Access To Affordable Drugs

Foley & Lardner LLP on

Following months of public outcry and Congressional probes into significant drug price increases, the Senate Judiciary Committee introduced legislation targeting “behavior that blocks competition and delays the creation of...more

Mintz - Health Care Viewpoints

Congress Proposes Legislative “Fixes” to Drug Industry Rules Believed to Be Contributing to High Costs

We spend a lot of time covering prescription drug costs on this blog, and even convened a Pharmacy Industry Summit earlier this year focusing on the various pressures that are contributing to higher drug prices. Although...more

Benesch

Senators Introduce the CREATES Act

Benesch on

In furtherance of the government’s efforts to bring down healthcare costs, Senators Patrick Leahy (D-VT.), Chuck Grassley (R-IA), Amy Klobuchar (D-MN), and Mike Lee (R-UT) have introduced the Creating and Restoring Equal...more

Fish & Richardson

Legislative Developments in Post-Grant Proceedings

Fish & Richardson on

Amidst a spate of high-profile IPR filings in the life sciences space by hedge fund financiers, the biotechnology industry has mobilized behind two chief legislative strategies designed to limit or eliminate its exposure to...more

Foley & Lardner LLP

Federal Circuit Finds Personal Jurisdiction Based On Plans To Market ANDA Product

Foley & Lardner LLP on

In Acorda Therapeutics Inc. v. Mylan Pharmaceuticals Inc., the Federal Circuit held that the filing of an Abbreviated New Drug Application (ANDA) and intentions to market the product across the United States–including in the...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

McDonnell Boehnen Hulbert & Berghoff LLP

Senators Introduce Another Bill to Ban Reverse Payment Settlement Agreements

Last week, Senator Al Franken (D-MN) was joined by Senators David Vitter (R-LA), Dick Durbin (D-IL), Jeanne Shaheen (D-NH), and Bernie Sanders (I-VT) in introducing S. 204, the "Fair and Immediate Release of Generic Drugs...more

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