Skip Navigation

Close and don't show again.

Your browser is out of date.

You may not get the full experience here on National Journal.

Please upgrade your browser to any of the following supported browsers:

HHS may appeal, issue guidance regarding 340B orphan drug exclusion HHS may appeal, issue guidance regarding 340B orphan drug exclusion

NEXT :
This ad will end in seconds
 
Close X

Not a member or subscriber? Learn More »

Forget Your Password?

Don't have an account? Register »

Reveal Navigation
 

 

Document Library

HHS may appeal, issue guidance regarding 340B orphan drug exclusion

Issued By
June 14, 2014

The Department of Health and Human Services is evaluating its options for responding to a recent federal court ruling that invalidated a 2013 final rule allowing certain hospitals to purchase "orphan drugs" through the 340B Drug Pricing Program when the drugs are not used to treat the rare conditions for which the orphan drug designation was given. In a document filed with the court yesterday, HHS said its options include appealing the decision or propounding a rule or guidance setting forth its interpretation of the law regarding the program's orphan drug exclusion. "HHS does not interpret the Court's decision as precluding it from issuing an interpretive rule or other type of interpretive guidance, even if the rule or guidance sets forth the same interpretation previously embodied in the challenged regulation," the agency wrote. The U.S. District Court for the District of Columbia last month ruled that HHS and its Health Resources and Services Administration did not have the rulemaking authority to issue, as a legislative rule, its new regulation addressing the treatment of orphan-designated drugs under the Section 340B Program. The 2013 rule applied to critical access hospitals, sole community providers, rural referral centers and free-standing cancer hospitals. AHA filed a friend-of-the-court brief supporting HHS in the lawsuit, which was brought by the Pharmaceutical Research and Manufacturers of America.

distributed by noodls logo

This document was issued by AHA - American Hospital Association and was initially posted at www.ahanews.com. It was distributed, unedited and unaltered, by noodls on 2014-06-14 12:10:30. The original document issuer is solely responsible for the accuracy of the information contained therein.

Search the document library
What's This?
X
What's This?

The new National Journal Document Library is a collection of research reports, testimony, white papers and press releases regularly updated from hundreds of sources including governmental agencies, global think tanks, trade associations, academic institutions and companies. National Journal Members have full access to the Document Libraryfull access to the Document Library and its advanced search and alerting features. Non-members can access up to five documents per month.

Job Board
Search Jobs
Part-Time Quality Intern
American Society of Civil Engineers | Fort Smith, AR
Technical Manager
American Society of Civil Engineers | Elk Grove Village, IL
Land Management Intern
American Society of Civil Engineers | Newark, CA
Electrical Intern/Co-op - Aviation Facilities
American Society of Civil Engineers | Philadelphia, PA
Certification Administrator
American Society of Civil Engineers | Durham, NC
Civil Engineering Internship
American Society of Civil Engineers | Gurnee, IL
Water-Based System Technician- NICET Level II
American Society of Civil Engineers | Killeen, TX
PRODUCT REVIEW ENGINEER
American Society of Civil Engineers | CA
Fire Alarm System Technician, NICET Level II
American Society of Civil Engineers | Killeen, TX
Biotechnology Team Advisor
American Society of Civil Engineers
Intern - Engineering/Water Resources
American Society of Civil Engineers | Lacey, WA
Summer Internship
American Society of Civil Engineers | Troy, MI
Faculty Positions
American Society of Civil Engineers | Dhahran
Professional Services - Trainer
American Society of Civil Engineers | Marietta, GA
Engineering Field Technicians
American Society of Civil Engineers | Campbell Hall, NY
 
Comments
comments powered by Disqus