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April 11, 2019

This week in Washington

The costs of prescription drugs continues to be the focus on Capitol Hill, with hearings and legislation aimed at lowering costs for patients. AGA is also championing new legislation that would protect patients subject to step therapy protocols.

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Major step forward in step therapy fight. Rep. Raul Ruiz, D-CA, and Brad Wenstrup, R-IN, introduced H.R. 2279, Safe Step Act, legislation that would provide patients subject to step therapy protocols a clear and equitable appeals process and common sense exceptions for patients. Please help AGA secure support and cosponsors for this critical legislation by taking action!


Senate questions roles of pharmacy benefit managers. The Senate Finance Committee has focused on prescription drug costs and held a hearing on the role of pharmacy benefit managers (PBMs) and the lack of transparency in the deals they negotiate with pharmaceutical companies and insurers. Ranking Member Sen. Ron Wyden, D-OR, noted that there is little evidence that PBMs have lowered costs for consumers and that PBMs make more money when they choose higher price drugs.

Energy and Commerce Committee approves several bills aimed at reducing drug costs. The Energy and Commerce Committee held a mark-up where they approved six bills that address the high cost of prescriptions drugs. All of the bills were approved in a bipartisan manner and the full House will vote on them in the next few months.

    • H.R. 965, the CREATES Act: legislation would penalize brand-name drug manufacturers who withhold samples to generic companies and use safety concerns as an excuse.
    • H.R. 1499: legislation would crack down on pay-for-delay where a brand-name drug manufacturer makes a deal with a generic rival to keep their product off the market.
    • H.R. 938: legislation would limit first-approved generic makers’ ability to delay other rivals.
    • H.R. 1520 and H.R. 1503: legislations would provide generic and biosimilar makers more information through FDA databases about the patents on branded products.
    • H.R. 1781: legislation would increase congressional advisory committee’s access to pricing and rebate data.

AGA weighs in on proposed changes impacting drug rebates. On April 8, AGA submitted a letter to the Office of the Inspector General in response to a proposed rule that would remove certain protections for rebates involving prescription drugs and create new protections for certain point-of-sale price reductions. AGA supports the proposed changes to the safe harbor protections. In the letter, AGA expressed hope that the proposed changes will result in a shift away from retroactive rebates to upfront discounts that benefit patients.

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