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H.R. 3678 · 114th Congress

Preserving Access to Orphan Drugs Act of 2015

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Never voted on. It didn't reach a floor vote before the 114th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.

MKR KellySponsor
10 cosponsors · 2 D, 8 R

8 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.

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.

What it does: CRS summary · Introduced in House · Oct 1, 2015

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.

Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov

About this bill and sources

Official title: Preserving Access to Orphan Drugs Act of 2015

Latest action (Oct 2, 2015): Referred to the Subcommittee on Health.

Policy area: Health · Origin: House · Introduced: Oct 1, 2015

Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)

No recorded floor vote found.