Drugs

Generics Lobby Backs China Tariff Drug Exclusion

The Association for Accessible Medicines (AAM) says it supports the administration’s decision not to include pharmaceuticals and certain pharmaceutical inputs on the most recent list of Chinese exports that would face U.S. tariffs when imported into this country. In a letter to U.S. trade representative Robert Lightizer, AAM says placing tariffs on the drugs would harm efforts to reduce drug prices in the U.S. The association makes these points:

imposition of tariffs on generic drugs, biosimilars, or their ingredients would “have a perverse effect on healthcare spending in the United States”;
if a 25% tariff were imposed, it would likely have a greater impact on generic producers than on their branded counterparts because manufacturing represents a much greater proportion of generic producers’ costs;
drug manufacturers are held to the same high quality and safety standards by FDA regardless of where pharmaceutical manufacturing takes place; and
imposition of tariffs on pharmaceuticals is much more likely to increase the risk of drug shortages in the U.S. than it is to result in elimination of problematic Chinese polices and practices involving technology transfer, intellectual property, and innovation.

Rasonque OK’d Across KRAS Mutations Despite Clinical Response Differences

FDA granted approval to Revolution Medicines' Rasonque (daraxonrasib) for metastatic pancreatic cancer despite substantial differences in treatment responses among patients with different KRAS mutations and limited evidence of effectiveness in patients without RAS mutations, according to a newly released approval document. The 321-page review shows that FDA considered

FDA Safety Concerns Complicate Plan to Expand Peptide Compounding

The Trump Administration is developing a temporary policy that would allow compounding pharmacies to dispense certain unapproved peptides despite earlier FDA scientific assessments finding insufficient evidence of their safety and effectiveness, setting up a potential conflict between administration policy and the agency's scientific reviewers. Federal officials are considering

DoJ Enforcement Directive Signals More Scrutiny of FDA-Regulated Firms

A new Department of Justice directive identifying violations of the Federal Food, Drug, and Cosmetic Act (FDCA) among potential targets for fraud enforcement could expose FDA-regulated firms to increased federal investigations and criminal prosecutions, according to an analysis by attorneys at Holland & Knight. The 10/1 directive outlines

Guide on Biosimilar Postapproval Manufacturing Changes

FDA has released a final guidance entitled “Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products — Questions and Answers.” The document explains how manufacturers should document and report changes to approved biosimilars, including changes involving manufacturing processes, production facilities, dosage forms and strengths. Regarding information required for postapproval manufacturing changes,

Read more

Rasonque OK’d Across KRAS Mutations Despite Clinical Response Differences

FDA Safety Concerns Complicate Plan to Expand Peptide Compounding

DoJ Enforcement Directive Signals More Scrutiny of FDA-Regulated Firms

Guide on Biosimilar Postapproval Manufacturing Changes