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May 1, 2019

Potential for more GI research funding and more generic GI drugs

House approves increased NIH funding and bills to address drug prices.

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House Appropriations Subcommittee approves NIH funding increase. The House Appropriations Subcommittee on Labor-HHS-Education approved the fiscal year 2020 spending bill that would increase the budget for HHS by $8.5 billion. The spending bill also includes a $2 billion increase in funding for the NIH and rejects proposed cuts by President Trump to NIH and CDC. AGA and the entire medical research community are advocating for a $2.5 billion increase in NIH funding and appreciate the committee’s support for NIH.

House Judiciary approves bills aimed at addressing drug prices. The House Judiciary Committee approved four bipartisan bills aimed at increasing the development of generic drugs, increasing competition and therefore lowering costs of drug prices for consumers. All four bills were approved by voice vote and had strong bipartisan support, and are expected to be voted on by the full House. The following bills include:

    • H.R. 965, Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act. The legislation would allow generic manufacturers to request FDA authorization to obtain sufficient quantities of drug samples necessary for testing and developing a generic. The bill seeks to crack down on brand name drug companies who refuse to share samples and thus prevent generics from being developed. This bipartisan legislation was also approved by the Energy and Commerce Committee and is expected to be voted on by the full House. The Senate is also expected to approve this legislation which also has the support of President Trump.
    • H.R. 2375, Preserve Access to Affordable Generics and Biosimilars. The legislation would prohibit brand name drug companies from compensating generic companies to delay the entry of a generic, biosimilar or interchangeable biological product to market, also known as “pay-for-delay.”
    • H.R. 2374, the Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics (STALLING) Act. The legislation seeks to deter the filing of sham citizen petitions at the FDA used to prevent the approval of generic drugs or biosimilars.
    • H.R.  2376, the Prescription Pricing for People Act. The legislation would require the Federal Trade Commission to study whether pharmacy benefits managers have been anticompetitive and make recommendations to Congress.

House Energy and Commerce holds hearing on Medicare prescription drugs. Prescription drug prices continued to be the focus of the Energy and Commerce Health Subcommittee as they examined the costs of drugs in the Medicare Part D program. During the hearing, Rep. Raul Ruiz, D-CA, a member of the subcommittee and sponsor of the Safe Step Act, voiced his concern that CMS must include a system of appeals and safeguards for patients if CMS moves forward with allowing Part D plans to use step therapy. Rep. Ruiz recently introduced the Safe Step Act that would provide a clear and transparent appeals process and exceptions for patients when subject to such protocols.

House Rules Committee holds “Medicare for All” hearing. The House Rules Committee, known as the “traffic cop” of the committees in the House since every bill needs to pass through Rules before heading to the floor, held the first hearing on Medicare for All. The Rules Committee does not have authorizing jurisdiction over Medicare for All but Speaker Nancy Pelosi, D-CA, directed them to begin the hearing process and keep a promise to the progressive members of her caucus that she would debate the issue. The Ways and Means Committee Chair Richard Neal also announced that his committee would hold a hearing on the proposal and Republicans are happy to keep the issue at the forefront of the debate since they believe most Americans do not support eliminating private health insurance.

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