HR 3678
114th Congress
House
Health
Drug safety, medical device, and laboratory regulation
Drug therapy
Health care coverage and access
Prescription drugs
User charges and fees
Preserving Access to Orphan Drugs Act of 2015
Introduced: October 1, 2015
Introduced by:
Kelly, Mike
Republican
· Pennsylvania
See on congress.gov
Everywhere this bill has been
4 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Oct 2, 2015
Referred to the Subcommittee on Health.
Oct 1, 2015
Referred to the Subcommittee on Health.
Oct 1, 2015
Referred to the Committee on Ways and Means, and in addition to the Committee on Energy and Commerce, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Oct 1, 2015
Introduced in House
Plain-English summary
Preserving Access to Orphan Drugs Act of 2015
This bill amends the Patient Protection and Affordable Care Act to expand the definition of orphan drug for purposes of the annual fee paid by brand name prescription drug manufacturers and importers to include medications for rare conditions that were, prior to 2011, approved or in clinical trials. (Drug manufacturers and importers pay an annual fee based on their sales of brand name prescription drugs, excluding sales of orphan drugs.) Currently, only medications for rare conditions for which a tax credit for clinical trials was allowed are considered orphan drugs.
This Act applies to fees paid after 2014.
What's happening now
Referred to the Subcommittee on Health.
Committees of jurisdiction
4
Cosponsors
1