WASHINGTON, DC – Yesterday, Axios highlighted key actions taken by the FDA to accelerate the approval of new generic drugs to market and to aid in reducing costs for prescription drugs for consumers. These improvements were made possible by FDA Commissioner Dr. Scott Gottlieb’s prioritization of this critical issue as well as bipartisan, bicameral legislative work led by the Energy and Commerce Committee.
Last year, the House Energy and Commerce Committee advanced the Food and Drug Administration Reauthorization Act (FDARA) to the full House by a unanimous vote of 54 – 0. The bill then went on to pass the full House by voice vote before being signed into law by President Trump. FDARA reauthorized the Generic Drug User Fee Amendment, and established a pathway to incentivize the entrance of competitive generic drugs where there was a lack of competition in the marketplace, resulting in an ability to decrease costs to consumers. We have already seen generic drugs come to market through these new pathways, and prices beginning to drop for consumers on a variety of medications.
Learn more about FDARA HERE.
FDA’s generics blitz
By: Sam Baker
One of the Trump administration’s most concrete efforts to lower drug prices is an approach that’s been around for decades: approving more generic drugs. And it’s moving fast.
By the numbers: FDA approved 781 generic drugs in fiscal 2018. That’s 90% more than in 2014, when Congress provided new authorities designed to speed the approval process, according to a PwC report.
Between the lines: Some generics are more important than others.
- The approval of a generic EpiPen this past summer was seen as an especially big deal. Generic versions of complex products (like the EpiPen) are harder to produce, and the FDA has said it’s especially invested in helping those products get to the market.
Yes, but: The first generic competitor to a brand-name product often isn’t the one that brings prices way down. Generics can still make a lot of money by being just slightly cheaper than the product they’re copying, so the steepest discounts often don’t appear until multiple generics hit the market.
What’s next: FDA Commissioner Scott Gottlieb is trying to standardize key parts of the review process in the U.S. and Europe, so that generics could more easily seek approval in both regulatory systems.
Read the article online HERE.