Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 needs your help!
Via Congress.gov the Open Act stands to accelerate cures and treatments for rare disease and it could quite possible double the number of treatments for rare disease.
If you are not familiar with the OPEN ACT legislation, now is the time to read up and join the movement! HR 971/S 1421 supports Orphan Product Extensions and is supported by more than 160 national patient organizations (according to RDLA- click here to read their overview and download the pdf.)
The Open Act was brought to the House back in February of 2013 by Florida Republican Representative Gus Bilirakis with the official title to:
“Amend the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to extend by six months the exclusivity period for an approved drug or biological product 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”).”
Go on …
- Allows the FDA to revoke an extension if the application for the new indication contained an untrue material statement.
- Requires the sponsor of a product receiving an extension to notify the FDA one year prior to discontinuing production for commercial reasons.
- Requires the FDA to notify the public of products that receive this extension and patents related to those products.
- Limits a product to one extension under this Act. Sets forth that extensions under this Act are in addition to other extensions.
- Applies only to products approved after enactment of this Act for a new indication that is a rare disease or condition.
Sounds great! Right? So what’s the Dilemma?
Well, days after it was introduced to the House by Rep. Gil, it was referred to the House Committee on Energy and Commerce. A few days later it was to the Subcommittee on Health and entered “Committee Consideration”. It’s been sitting in the introduction phase since.
The OPEN ACT was left out of the 21st Century Cures Act draft in the House. After hundreds of patient advocates called their Congresspersons urging them to put OPEN back in, lawmakers did… so #greatsuccess.
But, now the OPEN ACT has been left out by the Senate, despite the support of 160 national patient organizations. Argh political people! There aren’t enough treatments for rare disease!
Raise your voices! Call your local Senators and urge them to get this passed.
Want to Read some of our Contributors’ Perspectives on the 21st Century Cures Act? Check out the below posts and be sure to leave a comment.
