Eli Lilly Joins Lawsuit to Defend Drug Patent Against Compounding Pharmacies Amid FDA Regulatory Dispute

Washington, D.C. — Pharmaceutical giant Eli Lilly has entered the legal fray by filing a motion on January 1 to join a lawsuit challenging the U.S. Food and Drug Administration’s (FDA) decision regarding the manufacturing of generic versions of GLP-1 drugs, such as those Lilly markets under the names Mounjaro and Zepbound. The company asserts significant stakes in the ongoing legal battle over whether compounding pharmacies may continue creating generics previously necessitated by drug shortages. The initial lawsuit was launched in October by the Outsourcing Facilities Association and FarmaKeio Custom Compounding, a Texas-based compounding pharmacy. … Read more

RFK Jr. Associate Challenges FDA, Seeks Revocation of Polio Vaccine Approval

In a controversial move, an ally of environmental lawyer and anti-vaccine advocate Robert F. Kennedy Jr. has filed a petition seeking to rescind the U.S. Food and Drug Administration’s approval of the polio vaccine, sparking a debate on public health and vaccine safety. This push against one of the most historically significant medical interventions highlights the enduring tensions between vaccine skepticism and scientific consensus. The petition, put forth by Celia Ostrove, a member of Kennedy’s nonprofit organization, criticizes the vaccine’s safety and efficacy. This action coincides with Kennedy’s broader campaign questioning the safety of various … Read more

Reedley Lab Owner Sues City and FDA, Alleges Rights Violations in Wake of Illegal Operation Crackdown

Reedley, Calif. — A controversy continues to unfold more than a year after government officials unearthed an unauthorized laboratory in Reedley, leading to a complex legal battle. The owner of the lab, David He, also known as Jia Bei Zhu, has initiated a lawsuit against the City of Reedly and the FDA, alleging significant violations of his constitutional rights. This legal action did not catch the city officials off guard. Reedley’s City Manager, Nicole Zieba, commented on the city’s readiness to face these allegations, revealing that He had previously sought a substantial $50 million in … Read more

FDA Approves Groundbreaking Program Allowing Importation of Canadian-Approved Drugs Into the U.S.

TALLAHASSEE, Fla. – The U.S. Food and Drug Administration (FDA) has recently approved a proposal that allows for the importation of Canadian-approved pharmaceuticals into the United States. This marks the first time that a program of its kind has been implemented, enabling a state to import drugs approved by a foreign regulator. The program, known as the Section 804 Importation Program (SIP), allows U.S. states or tribes to apply for approval to import drugs that were initially approved by Health Canada instead of the FDA. Florida is the first state to receive FDA approval for … Read more