Polsinelli Podcasts - Confusion to Clarity on the Future of the 340B Program
In April 2023, we published an alert in relation to two European Commission legislative proposals: new Regulation 2023/0131 and new Directive 2023/0132, to replace the current EU regulatory framework for all medicines...more
The Inflation Reduction Act (IRA) was signed into law in August 2022 with the goal of curbing inflation by, among other things, lowering prescription drug prices. Notable prescription drug provisions of the IRA include the...more
This update is the final in a multi-part series exploring FDA approval of pet care drugs. In part one of our series we discussed that before an animal drug product can be legally marketed for use in animals, a New Animal Drug...more
On June 30, 2023, the Centers for Medicare and Medicaid Services (CMS) released its much-anticipated final guidance (“Final Guidance”) for the Medicare Drug Price Negotiation Program (“Negotiation Program”) through the...more
We recently published an alert in relation to the European Commission’s legislative proposals to replace the current EU regulatory framework for all medicines (including those for rare diseases and for children). One of the...more
Last month, the Food and Drug Administration’s Office of Orphan Products Development (“OOPD”) found that one prescription drug company was able to, essentially, breach another’s orphan drug exclusivity (and have its new drug...more
The Inflation Reduction Act of 2022 (IRA) establishes the Medicare Drug Price Negotiation Program (“Negotiation Program”), which permits the government to negotiate drug prices for certain high expenditure, single source...more
While many provisions of the FY 2023 Consolidated Appropriations Act (Omnibus) have received much attention, one has flown under the radar. In its explanatory statement on the Omnibus, the US Congress indicated that it is...more
Recently, the Food and Drug Administration published a Notification to clarify its policy about orphan drug exclusivity. The agency issued the announcement because the U.S. Court of Appeals for the 11th Circuit found that FDA...more
We are committed to providing insightful commentary on IP developments from around the world to our Japanese clients. In light of that effort, we are continuing our free monthly webinar series, McDermott IP Focus. During...more
On January 24, 2023, FDA published a notice in the Federal Register entitled, “Clarification of Orphan-Drug Exclusivity Following Catalyst Pharms., Inc. v. Becerra.” In brief, the Catalyst decision by the 11th Circuit Court...more
On January 24, the Food and Drug Administration (FDA) made a long-awaited announcement with major implications for how the agency awards exclusivity for rare disease drugs under the Orphan Drug Act (ODA) (P.L. 97-414)....more
On January 24, 2023, the Food and Drug Administration published a notice in the Federal Register to “address the uncertainty” created by the US Court of Appeals for the Eleventh Circuit’s September 30, 2021, decision in...more
The Food and Drug Administration (“FDA” or the “Agency”) user fee negotiations may have hit an iceberg, but it did not sink all the legislative riders that accompanied this summer’s House and Senate bills. Buried within the...more
In a long-awaited decision published on 31 May 2021, the IAA found that Leadiant infringed Article 102 TFEU through a multifaceted strategy that led to it obtaining an excessive price for its CDCA Leadiant® medicine. A number...more
On 31 May 2022, the Italian Competition Authority (ICA) published its decision sanctioning the pharmaceutical company Leadiant EUR3.5 million for charging excessive prices for the sale of an orphan drug....more
Last week, the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA) launched a new program to coordinate and centralize CDER’s rare disease activities. The mission of the Accelerating Rare...more
Last week, Regeneron Pharmaceuticals, Inc. and Sanofi announced that the FDA has accepted a Priority Review of the supplemental Biologics License Application (sBLA) for DUPIXENT (dupilumab) 300 mg weekly to treat patients...more
Orphan drugs are the pharmaceutical industry’s way of helping those who suffer from rare conditions. Thanks to the Orphan Drug Act, such patients can get the medications they need, and pharmaceutical companies can be duly...more
With the issuance of its mandate on January 28, 2022, in Catalyst Pharmaceuticals, Inc. v. Becerra, the U.S. Court of Appeals for the Eleventh Circuit has upheld the orphan exclusivity for Catalyst Pharmaceuticals, Inc....more
On September 30, 2021, the U.S. Food and Drug Administration (FDA) announced final guidance titled “Interpreting Sameness of Gene Therapy Products under the Orphan Drug Regulations.” The guidance finalizes the January 2020...more
While it may feel like FDA’s attention has been focused on COVID-19 for nearly two years, as we have written about in a previous blog post, FDA is looking to the future, and particularly, one that signals exciting prospects...more
How is orphan drug exclusivity affected when the FDA-approved use for an orphan drug is arguably narrower than the treatment of the rare disease it was designated for? By way of background, a sponsor can obtain orphan drug...more
Recently, the U.S. Food and Drug Administration’s (FDA’s) Office of Orphan Product Development published the four-page final guidance “Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations,” which...more
This week in Washington: Talks continue on infrastructure, Senate committees moving forward on health legislation, President’s budget due the end of the week....more