340B programme: PhRMA files court challenge to final rule on orphan drug exception

On 27 September, the Pharmaceutical Research and Manufacturers of America (PhRMA) filed suit against the Department of Health and Human Services (HHS) challenging the 340B orphan drug final rule. The complaint seeks both to invalidate the final rule and enjoin (stop) its implementation.

As you may recall, the Affordable Care Act expanded the 340B programme to add certain new categories of eligible covered entities but excluded drugs subject to an orphan designation from the 340B ceiling price requirement as to those entities. The final rule, which became effective on 1 October 2013, interpreted that ceiling price exception narrowly, to apply only to orphan drugs when used for the indication subject to the orphan designation. As a result, the final rule allows the new covered entity types to purchase orphan drugs at the 340B ceiling price when those drugs are used for non-orphan indications.

PhRMA makes two arguments in support of its legal challenge. First, PhRMA alleges that the final rule is inconsistent with the statute. PhRMA’s position is that the statutory language that creates the ceiling price exception applies to the orphan drug as a whole, and not on an indication basis. Second, PhRMA alleges that neither HHS nor the Health Resources and Services Administration (HRSA) had authority to issue a rule interpreting the orphan drug exception…

If you are registered and logged in to the site, click on the link below to read the rest of the Hogan Lovells briefing. If not, please register or sign in with your details below.

Sign in or Register to continue reading this article

Sign in


It's quick, easy and free!

It takes just 5 minutes to register. Answer a few simple questions and once completed you’ll have instant access.

Register now

Why register to The Lawyer


Industry insight

In-depth, expert analysis into the stories behind the headlines from our leading team of journalists.


Market intelligence

Identify the major players and business opportunities within a particular region through our series of free, special reports.


Email newsletters

Receive your pick of The Lawyer's daily and weekly email newsletters, tailored by practice area, region and job function.

More relevant to you

To continue providing the best analysis, insight and news across the legal market we are collecting some information about who you are, what you do and where you work to improve The Lawyer and make it more relevant to you.

Briefings from Hogan Lovells

View more briefings from Hogan Lovells

Analysis from The Lawyer

View more analysis from The Lawyer


Atlantic House
Holborn Viaduct

Turnover (£m): 1,098.00
No. of lawyers: 2,313 (UK 200)
Jurisdiction: UK
No. of offices: 8
No. of qualified lawyers: 219 (International 50)
No. of partners: 56