Senators Propose New Bills with Big Incentives, Including 15 Year Marketing Exclusivity

Dec. 16, 2014

Senators Orrin Hatch and Michael Bennet have proposed two new pieces of legislation -- Dormant Therapies Act of 2014 and Promise for Antibiotics and Therapeutics for Health (PATH) Act -- with the former providing drug makers with an unprecedented 15 years of data exclusivity for a medicine that meets an unmet medical need.

The Dormant Therapies Act, which is essentially a companion piece to a bill that was introduced last year in the U.S House of Representatives, will create a new designation — Dormant Therapy Designation — modeled off of FDA's other existing designation programs.

Those FDA programs, such as the fast-track and orphan product designations, are intended to offer special incentives, such as added periods of marketing exclusivity and additional support during the review process.

The second piece of legislation, the PATH Act, would allow the FDA to approve some antibiotics through a special "limited use" regulatory pathway, all in the hope of bringing more antibiotics to market to help fight antibiotic-resistant bacteria.

The thought process behind the PATH Act is that by limiting the assessment of the drug to the specific population, drug sponsors might be able to obtain approvals both more quickly and more easily.

Read more about both pieces of legislation at RAPS