Podcast — Drug Pricing: How Are Payers Responding to the IRA?
340B Drug Pricing Program Compliance
Inflation Reduction Act’s Drug Price Negotiation Provisions – What Now? – Diagnosing Health Care Podcast
Podcast: Inflation Reduction Act’s Drug Price Negotiation Provisions – What’s Next? - Diagnosing Health Care
Podcast: Chevron Deference: Is It Time for Change? - Diagnosing Health Care
Part Two: The MFN Drug Pricing Rule and the Rebate Rule: Where Do We Go From Here?
Part One: Two new Medicare Drug Pricing Rules in One Day: What are the MFN and the Rebate Drug Pricing Rules?
On the Ballot 2020: Health Care Policy Outlook - Diagnosing Health Care Podcast
Podcast: IP(DC): Drug Prices, Political Pressures & Patents
Drug Pricing Initiatives During the Trump Presidency
K&L Gates Triage: An Insider’s Perspective on the Health Care Debate in Washington, DC
K&L Gates Triage: 340B Regulatory Update: CMS Proposal and Draft Executive Order Could Have Big Impact on 340B Program
K&L Gates Triage: 340B Eligibility - Hospital Covered Entities
Measures of success: How value-based pricing may change the pharmaceutical industry
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
It has been a busy year for issues related to drug pricing, and with the election around the corner, litigation issues that have been developing over the last few years are likely to be a key focus for the second half of...more
The Federal Trade Commission (FTC) has called attention in the past year to its perception of the influence that branded pharmaceutical companies have over the price of beneficial drugs. Most recently, the agency has asserted...more
ANDA litigation is a high-stakes niche of pharmaceutical law that presents unique challenges not only for lawyers, but also for eDiscovery practitioners. Here’s why: under the Drug Price Competition and Patent Term...more
Hosted by American Conference Institute, the 20th Annual Paragraph IV Disputes & the 40th Anniversary of the Hatch-Waxman Act returns for another exciting year with curated programming that will take a retrospective look at...more
As we reflect on 2023 and make predictions for 2024, it is remarkable the number of significant events occurring this past year that will be impactful for the activities of the life sciences industry going forward. Although...more
December 7, 2023, President Biden announced new actions to promote competition in health care and to lower prescription drug costs. Of particular note is a newly unveiled framework for deciding whether the Government may...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
Over the past several years Congress has tried to address high drug prices, with variable success (see "FTC to the Rescue Regarding High Drug Prices and Patents"; "Even More Ill-Conceived Remedies from Congress Regarding...more
On January 19, 2023, the FDA Commissioner, Robert M. Califf, delivered remarks at the FDA-USPTO Public Workshop. He noted that, since the issuance of President Biden’s 2021 Executive Order on Promoting Competition, the FDA...more
On January 31, 2022, Sen. Thom Tillis (R-N.C.), the Ranking Member of the Senate Judiciary Committee Subcommittee on Intellectual Property, sent a letter to Janet Woodcock, Acting Commissioner of the FDA, and Drew...more
Some Worry Reduction in Pharmaceutical Revenues May Impact New Drug R&D and Innovation - Lowering prescription drug pricing has been a hotly debated issue well before 2022 and is expected to continue in 2022. In November...more
As 2021 comes to a close, Big Molecule Watch reviews the top five biosimilar regulatory developments of the year... President Biden Signs Orange Book Transparency Act - In January, we reported that President Biden...more
In the wake of the nomination of Kathi Vidal as Director of the USPTO, there will be significant attention paid to the agency’s responses to calls from both the executive and legislative branches to remake the agency’s...more
Skinny labels are back in focus at the White House. On September 9, 2021, the U.S. Department of Health and Human Services submitted its much-anticipated report to the White House Competition Counsel regarding a...more
On Friday, July 9, 2021, President Biden released an Executive Order “to promote competition in the American economy” and to “to reduce the trend of corporate consolidation” (the "Order"). As part of this Order, the Biden...more
On July 9, 2021, President Biden enacted a sweeping executive order creating a “whole‑of-government competition policy.” Morrison & Foerster outlined the administration’s policy in a recent client alert that provides a...more
Drug pricing and innovation are hot topics in Washington right now with several bills making their way through the legislative process, many in a bipartisan fashion. On April 23, 2021, two of these bills were signed into law...more
Congressional Developments on Life Science and Consumer Product Issues - Legislation - Citizen Petitions: House Subcommittee Approves Bill to Prevent Overuse - To address the abuse of citizen petitions that delay...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
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
With Big Pharma pressing the limits in promoting and pricing prescription medications, patients and their advocates long have hoped that generic drugs might be difference-makers on costs and practices. Those positive wishes,...more
Recently, the United States Food and Drug Administration (FDA) Commissioner Scott Gottlieb issued a statement (the statement) outlining a new policy to improve access and foster price competition for branded drugs that are...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