Monthly Archives: June 2017

FDA Publishes List of Off-Patent/Off-Exclusivity Drugs Without Generic Competition

“Today, the U.S. Food and Drug Administration is taking two new, important steps to increase competition in the market for prescription drugs and facilitate entry of lower-cost alternatives. The agency published a list of off-patent, off-exclusivity branded drugs without approved generics, and also implemented, for the first time, a new policy to expedite the review of generic…

Biosimilar Developers Score Big in Supreme Court

According to a SCOTUSblog Opinion analysis on June 12, “The Supreme Court reverses another Federal Circuit patent case… Sandoz emerged as the clear victor in the case, winning the right to bring “biosimilar” versions of complex biologic drugs to market sooner and also gaining a small but potentially important procedural right for future litigations.” FiercePharma…

American Medical Association Seeks Inclusion of Drug Prices in DTC Ads

June 9 – FiercePharma reports “AMA aims at DTC ads again, this time to push inclusion of drug prices…Physicians attending the AMA annual conference in Chicago this weekend will again turn their attention to DTC ads with a new proposal to push drugmakers to list retail pricing, much like automakers do…Resolution 236 was introduced by New England medical societies from Connecticut,…

RAPS Reports User Fee Reauthorization Bill Advances in the House

“The House Energy and Commerce Committee on Wednesday voted unanimously (54-0) to advance its bill to reauthorize the US Food and Drug Administration’s (FDA) user fee programs for prescription and generic drugs, biosimilars and medical devices to the full House. The committee also adopted several amendments to the version of the bill, known as the FDA…

FDA Announces New “NDC Express” Mobile Application

FDA June 5 – FDA launched a mobile application (app) to offer access to National Drug Code (NDC) data from phones or tablets. The new app, NDC Express, presents the NDC database in a mobile-friendly format, using display and navigation features available in both Android and iOS devices. The Drug Listing Act of 1972 requires…

WHO Antibiotic Assay in Use since 1961 Flawed?

June 1 – ScienceDaily Publishes “Why antibiotics fail” When a patient is prescribed the wrong antibiotic to treat a bacterial infection, it’s not necessarily the physician who is at fault. The current antibiotic assay — standardized in 1961 by the World Health Organization and used worldwide — is potentially flawed.” Here’s the full story (University of…