HR 1353
114th Congress
House
Health
Administrative law and regulatory procedures
Department of Health and Human Services
Drug safety, medical device, and laboratory regulation
Prescription drugs
PATIENT Act of 2015
Introduced: March 13, 2015
Introduced by:
Bilirakis, Gus M.
Republican
· Florida
See on congress.gov
Everywhere this bill has been
3 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Mar 20, 2015
Referred to the Subcommittee on Health.
Mar 13, 2015
Referred to the House Committee on Energy and Commerce.
Mar 13, 2015
Introduced in House
Plain-English summary
Promoting Access for Treatments Ideal in Enhancing New Therapies Act of 2015 or the PATIENT Act of 2015
This bill amends the Federal Food, Drug, and Cosmetic Act to extend to five years the three-year marketing exclusivity period provided to certain new drugs that include an active ingredient that was already approved by the Food and Drug Administration.
A drug is provided this extended exclusivity period if it is approved for a new indication or use, or the drug has been reformulated or redesigned to:
- promote greater patient adherence to an approved treatment regime,
- reduce the public health risks associated with the drug,
- reduce side effects or adverse events,
- provide benefits to the health-care system, or
- provide other comparable patient benefits.
What's happening now
Referred to the Subcommittee on Health.
Committees of jurisdiction
2
Cosponsors
1