On March 29, Senator Al Franken and fifteen co-sponsoring Senate Democrats introduced a bill called the “Improving Access to Affordable Prescription Drugs Act” (S. 771). A companion bill (H. 1776) with the same title was introduced the same day in the House by Representative Schakowsky and four co-sponsoring House Democrats. The Senate bill sponsors characterize their proposal as “a major push to improve the Affordable Care Act (ACA) by bringing down the skyrocketing price of prescription drugs, one of the main reasons why health care costs are rising.”
Among other provisions, the bill proposes a change in exclusivity periods that may be of interest to our readers: Section 303 of the proposed bill, on “Rewarding innovative drug development,” proposes to “reduce the biological product exclusivity from 12 years to 7 years.” This is the most recent of a number of proposals to reduce the exclusivity period for new biologics—as we have covered in previous posts, the Trans-Pacific Partnership (TPP) agreement would have provided a minimum exclusivity period of 5 years for biologics data, and a bill proposed in the House last year would have shortened the exclusivity period for new biologics to 7 years.
For more coverage of the proposed bill, check out the summary released by the Senate bill sponsors (at the bottom of the press release here, or here), or the post on the proposed bill by FDA Law Blog, here.