Webinar: Orange Book listing sheets under the microscope
Key Considerations for Reshoring U.S. Drug Manufacturing
Drug Pricing Initiatives During the Trump Presidency
Podcast: IP Life Sciences Landscape: Aiding Orange and Purple Book Patent Owners in Developing PTAB Survival Skills
Patent law in Europe: What pharmaceutical companies need to know
EU excessive pricing laws
Polsinelli Podcast - Generic Drugs to Market - What's the Climate in 2014?
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more
The Inflation Reduction Act (“IRA”) was passed just over a year ago with a goal of lowering high drug costs for Medicare beneficiaries and reducing costs incurred by Medicare. A central piece to achieving the IRA’s goal of...more
On September 6, 2023, the Association for Accessible Medicines (AAM) released its 2023 U.S. Generic & Biosimilar Medicines Savings Report highlighting the significant economic contributions of generic and biosimilar...more
While mergers and acquisitions, and attendant financings may not be at a blistering pace globally, the prognosis for deal activity in the healthcare sector remains healthy, in particular as the consolidation of providers, the...more
On July 9, President Biden issued an Executive Order regarding competition in various sectors of the United States economy, including the healthcare market. Among the 72 initiatives set forth in the Order are instructions...more
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more
In This Issue - 1. Drug Manufacturing: Sen. Grassley Pressures Company Over Data Manipulation - 2. Medical Product Innovation: Update to 21st Century Cures Act in the Works - 3. Drug Pricing: Senate Finance...more
Congress - House - In Recess - Cummings and Sanders Seek Information About Possible Obstruction of a Congressional Investigation on Generic Drug Prices...more
To paraphrase what a one-time colleague once wrote about her bosses: Never trust Big Pharma, never trust Big Pharma, never trust Big Pharma. Here’s some of the latest evidence why: Even the industry’s so-called “white hats,”...more
Congress - Senate - Senate Vote Fails to Block Trump Administration’s Short-Term Health Plans - On Oct. 10, the Senate failed to block the Trump administration’s expansion of short-term insurance plans. The...more
Highlights this week: The Senate will give the final OK to opioids legislation, HHS gets full-year funding for the first time in forever, new bipartisan legislation would allow FDA to update labels on older generic drugs, and...more
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
• The administration’s drug pricing Blueprint combines proposals that are already under way with new initiatives that may or may not be adopted. • Many of the more dramatic proposals would require federal rulemaking or...more
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,...more
AZAR ILLNESS DELAYS WHITE HOUSE ANNOUNCEMENT ON DRUG PRICING INITIATIVE - Health & Human Services (HHS) Secretary Alex Azar is recovering at his home in Indianapolis following his second hospitalization in less than a week...more
The Trump administration and Republican-led Congress spent substantial time and political capital in 2017 on efforts to repeal and replace the Affordable Care Act (ACA) and enact sweeping Medicaid reform. By the end of the...more
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
President Donald Trump is considering appointing lawmakers to a bipartisan commission that would develop strategies to lower prescription drug prices, while senators last week called for greater transparency into how...more
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
I. REGULATIONS, NOTICES, & GUIDANCE - On March 8, 2016, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule entitled, “Medicare Program; Part B Drug Payment Model.” The proposed rule seeks...more
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
Senate Working Group Pressing Forward on Telehealth - As Congress focuses on bigger picture policy decisions, including broad budget negotiations and raising the debt ceiling, there are some exciting developments on the...more