OPEN Act
- Last Action
- 3/3/2017
Actions
- 2017-03-03Referred to the Subcommittee on Health.
- 2017-02-27Referred to the House Committee on Energy and Commerce.
- 2017-02-27Introduced in House
- 2017-02-27Introduced in House
CRS Summary
As of 2017-02-27 (00)
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 receive 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.Cosponsors (20)
- G. K. Butterfield (D-NC)
- Michael McCaul (R-TX)
- Leonard Lance (R-NJ)
- RODNEY FRELINGHUYSEN (R-NJ)
- Darren Soto (D-FL)
- Tim Murphy (R-PA)
- ANNA ESHOO (D-CA)
- Daniel Donovan (R-NY)
- Markwayne Mullin (R-OK)
- Donald Norcross (D-NJ)
- Jeff Fortenberry (R-NE)
- Jared Huffman (D-CA)
- Don Bacon (R-NE)
- Daniel Webster (R-FL)
- Steven Palazzo (R-MS)
- Francis Rooney (R-FL)
- ZOE LOFGREN (D-CA)
- Cathy McMorris Rodgers (R-WA)
- Albio Sires (D-NJ)
- Eric Swalwell (D-CA)
Subjects
- Administrative remedies
- Department of Health and Human Services
- Drug safety, medical device, and laboratory regulation
- Drug therapy
- Food and Drug Administration (FDA)
- Government information and archives
- Intellectual property
- Prescription drugs
Sourced from Congress.gov (public domain).
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.