Navigation Links
New FDLI Monograph Provides Expert Guidance on Selling Pharmaceuticals, Biologics to Federal Government
Date:7/28/2010

WASHINGTON, July 28 /PRNewswire-USNewswire/ -- In FDLI's latest monograph, Selling Pharmaceuticals and Biologics to the Federal Government: Federal Supply Schedule and Federal Pricing Requirements, Joy Sturm, Allison Pugsley and Stephen A. Smyers of Hogan Lovells US LLP detail how pharmaceutical and biologics manufacturers can deal effectively with government contracting requirements and price calculation requirements. The 73-page monograph (Volume 1, #5) succinctly describes how a manufacturer's commercial pricing decisions can have a significant impact on product pricing in the federal marketplace and, thus, on a drug or biologics company's bottom line.

As the monograph notes, manufacturers who seek to receive federal funds under certain Medicaid and Medicare programs must agree to participate in the Federal Supply Schedule (FSS) and Veterans Health Care Act of 1992 (VHCA) contracting and pricing programs. Increased federal enforcement efforts surrounding these programs, coupled with the recent extension of the VHCA federal pricing requirements to the Department of Defense's nationwide TRICARE pharmacy program, have stimulated manufacturers — of all sizes — to place additional emphasis on their federal contracting and pricing functions, according to the monograph.

This monograph provides lawyers, business leaders and pharmaceutical and biologics decision-makers with a user-friendly understanding of the mechanics of pricing calculations and federal contracting requirements; how common commercial pricing and discounting arrangements can affect the prices that a company must charge the government for its drugs and biologics; and how to spot issues and develop strategic thinking to minimize compliance risk and maximize commercial outcomes.

FDLI's Monograph Series is designed to provide in-depth, practical analysis and guidance on complex issues in food and drug law. Monographs are available by subscription (6 issues per volume) or individually, as downloadable PDF files.

Founded in 1949, FDLI publishes the award-winning, peer-reviewed Food and Drug Law Journal; the bimonthly magazine Update; FDA Directory; and dozens of books and publications for attorneys, regulatory affairs practitioners, scientists, health care professionals, government employees and marketers in the food and drug field.


'/>"/>
SOURCE Food and Drug Law Institute
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. CuraGen Provides Update on Velafermin, Belinostat and CR011-vcMMAE Clinical Development Programs
2. Access Pharmaceuticals Provides Update on Clinical Development Plan of ProLindac
3. Study Shows Combination Therapy Incorporating AVODART(R) and Tamsulosin Provides Continuous Symptom Improvement Over 2 Years
4. Raptor Pharmaceuticals Provides Update of Product Programs
5. Monogram Provides Update on Trofile(TM) Co-Receptor Tropism Assay
6. Arbios Provides Clinical Strategy for SEPET(TM) Pivotal Trial
7. Innocoll Provides a Progress Update on its Clinical Development Programs and Specialty Pharmaceutical Operations
8. Genaera Corporation Provides Highlights of Positive Phase 1 Trodusquemine (MSI-1436) Data from the North American Association for the Study of Obesity Annual Meeting
9. Favrille Provides Update on Timing of Analysis from Pivotal Phase 3 Clinical Trial; Reports Third Quarter 2007 Financial Results
10. Treatment with PEGASYS(R)/COPEGUS(TM) Provides Hope for Hepatitis C Patients Whose Infection Did Not Initially Respond to Peg-Intron(R)/Ribavirin
11. Improved Cornea Surgery Technique Provides Enhanced Transplant Success
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/7/2016)... -- KEY FINDINGS Patient warming and ... loss of blood during surgeries, lowering the risks ... after surgeries, and decreasing risks of SSIs. The ... warming system, surface warming systems, and intravascular warming ... at hospitals thus, lowering the healthcare costs by ...
(Date:12/7/2016)... 7, 2016 Research and Markets has announced ... User - Global Forecast to 2021" report to their offering. ... , , ... by 2021, growing at a CAGR of 7.3% during the forecast period ... prevalence of cancer and rapidly increasing geriatric population across the globe are ...
(Date:12/7/2016)... Dec. 7, 2016 DelveInsight,s, "Janus ... provides in depth insights on the pipeline ... Janus Kinase 3 (JAK3) Inhibitors. The DelveInsight,s ... stages of development including Discovery, Pre-clinical, IND, ... Preregistration. Report covers the product clinical trials ...
Breaking Medicine Technology:
(Date:12/7/2016)... ... 07, 2016 , ... Facial plastic surgeon, Dr. John D. Rachel of ... of proceeds to two local organizations: North Chicago Animal Control and Friends and Our ... a team of authorized and trained volunteers who support rescued animals held in the ...
(Date:12/7/2016)... , ... December 07, 2016 , ... ... Dallas, Texas, is condemning "scam operations" carried out by unethical locksmith companies and ... scam operations to a halt. According to Texas Premier Locksmith, these fraudulent locksmith ...
(Date:12/7/2016)... CA (PRWEB) , ... December 07, 2016 , ... The ... the holidays and winter seasons. One major study analyzing heart attacks among 138,602 ... to August of a given year. We would all agree of course–no time of ...
(Date:12/7/2016)... , ... December 07, 2016 , ... ... 2016 BOC Business Brilliance Awards under the Best New Product Launch category. Gensuite’s ... achieved through user experience. , BOC Global Events & Training Group is a ...
(Date:12/7/2016)... ... December 07, 2016 , ... Maureen ... Program at Reproductive Medicine Associates of Connecticut (RMACT). McLaughlin brings nearly 20 years ... three acupuncturists to help patients realize their family building goals. Acupuncture helps ...
Breaking Medicine News(10 mins):