Summary

                            To amend the Federal Food, Drug, and Cosmetic Act to authorize an extension of exclusivity periods for certain drugs that are approved for a new indication for a rare disease or condition, and for other purposes.

Introduced in House
Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017 or
the OPEN Act

This bill amends the Federal Food, Drug, and Cosmetic Act to require the
Department of Health and Human Services (HHS) to extend by six months the
exclusivity period for a drug or biological product approved by the Food and
Drug Administration (FDA) when the product is additionally approved to prevent,
diagnose, or treat a new indication that is a rare disease or condition (also
known as an orphan disease).

HHS may revoke an extension if the application submitted to the FDA for the new
indication contained an untrue material statement.

HHS must notify the public of products that receive this extension and patents
related to those products.

Products may recieve only one extension under this bill. Extensions under this
bill are in addition to other extensions.

The bill applies only to products approved after enactment of this bill for a
new indication that is a rare disease or condition.



                        

Actions

  • Referred to the Subcommittee on Health.

    Mar 3rd, 2017
  • Referred to the House Committee on Energy and Commerce.

    Feb 27th, 2017
  • Introduced in House

    Feb 27th, 2017
  • Introduced in House

    Feb 27th, 2017