Blog

»  Posts By   2015 

FDA Stay of Guidance Loosens Clinical Research Requirements to Encourage Research on Diet and Health

On October 30, 2015, the U.S. Food and Drug Administration (FDA) announced that it is staying select parts of a final Guidance on Investigational New Drug (IND) applications as it pertains to conventional foods and studies intended to support health claims. The partial stay is intended to encourage scientific research to explore the relationship between diet and health. The Guidance was originally issued in 2013 to clarify when researchers or...

American Medical Association Forms Telehealth Work Group

Early last month, the American Medical Association (AMA) formed a telehealth work group composed of clinical and technological experts from the medical community. The group will be charged with evaluating the accuracy of current Common Procedural Terminology (CPT) codes used in the provision of telehealth services, as well as developing recommendations for new telehealth CPT codes. The formation of the AMA telehealth group marks yet another positive step toward increasing...

Pharmaceutical Manufacturers Successful Against HHS in Recent District Court Ruling Regarding 340B Pricing

A recent decision by the U.S District Court for the District of Columbia will exclude all drugs with an "orphan" designation from the 340B Drug Pricing Program for rural and cancer hospitals. The pharmaceutical industry may perceive the ruling that the Health Resources and Services Administration’s interpretive guidance is contrary to the plain language of the 340B statute as a victory, while patient advocates and providers express concern over access...

FDA Draft Guidance Signals a Slightly More Flexible FDA-Approval Pathway for Orphan Drugs

The U.S. Food and Drug Administration (FDA) has recently reaffirmed its commitment to spurring the development for rare conditions with a Draft Guidance that appears to offer a more flexible approach to rare disease drug development. Since the passage of the 1983 Orphan Drug Act, drug manufacturers in the U.S. have been provided with incentives to develop drugs used to treat rare diseases which affect fewer than 200,000 people, referred to...

Frier Levitt Appeals PBM Audit, Reduces Clawback by $170,000

Frier Levitt marks another successful PBM audit appeal by helping a pharmacy to reduce the initial recoupment amount requested by a PBM by almost $170,000. Frier Levitt is well acquainted with the terms of the various PBM Manuals and understands exactly which types of documents are required to overturn findings. Our significant experience responding to PBM audits enables us to prepare effective responses to initial audit findings which substantially decrease...