Reducing the cost of prescription drugs continues to remain a priority for Congress and one of the few areas where there appears to be room for bipartisanship. One key piece of legislation that has support from both sides of the aisle is the Creating and Restoring Equal Access to Equivalent Samples (Creates) Act.
The main purpose of this bill is to make it easier for generic and biosimilar developers to obtain confidential information from branded drug manufacturers.
The bipartisan bill was first introduced in but stalled due to strong lobbying efforts against the measure from brand-name pharmaceutical companies. It was subsequently introduced in , and even made its way out of the Senate Judiciary Committee but never advanced for a floor vote. The latest version, , was recently of the House Energy and Commerce Committee by unanimous vote, 51 – 0 after Republicans and Democrats were able to on the language.
To do needed research, and, eventually have their application approved by the FDA, generic and biosimilar developers must obtain information regarding an already approved FDA drug or product. However, many pharmaceutical companies try to avoid providing this information to developers to protect their stronghold in the market. In fact, the Trump Administration has called attention to many companies that hide behind the need for their drug/product to have a risk evaluation and mitigation strategy (REMS) as a means to not sell samples to developers, further delaying the entrance of new competition in the marketplace.
In short, REMS was created to help manage risk and ensure patient safety. However, some branded drug manufacturers have refused to provide enough samples of their product(s) to generic developers so that they can do required testing and research. As currently written, “brand and generic drug makers are required to develop a single shared REMS program when a generic drugs seeks approval and the brand drug has a REMS associated with it” but sometimes the FDA will allow for a generic developer to develop their own comparable REMS program as noted . Generic manufacturers typically run into this issue of insufficient sampling when they try to make a generic copy of a drug that has REMS with Elements to Assure Safe Use or ETASU. You can read more on REMS and ETASU .
As proposed, the Creates Act would allow eligible product developers to bring a civil suit against the license holder(s) of a covered product if they fail to provide the information needed to conduct research in an affordable and timely fashion. The amended version of the bill would establish limits for these civil suits due to Republican members’ that it encourages generic developers to file pointless lawsuits and is “ripe for abuse by entities that have no intent to actually develop a generic or biosimilar version of the covered product.” This key change enabled Republicans to lend their support during the committee’s vote.
It remains to be seen if the Senate version of the bill, , which is backed by key Republican and Chairman of the Senate Finance Committee, Chuck Grassley, will be taken up for consideration. However, legislators from both parties agree that removing barriers to entry for biosimilars and generics are a key part of advancing access to affordable drugs.