From the House Energy & Commerce Committee Republicans press office:
WASHINGTON, DC – House Speaker Nancy Pelosi’s closely guarded, secretly negotiated, completely partisan bill has finally been unveiled. In response, all 24 Republicans, including Whip Scalise, on the House Energy and Commerce Committee criticized her partisan process to what has typically been, and should continue to be, a collaborative and bipartisan effort to bring down drug prices for the American people:
“We can solve this problem; we have solutions at the ready. We have advanced numerous policies aimed at lowering the costs of prescription drugs. In fact, in May, the House Energy and Commerce Committee passed bipartisan legislation to bring down prescription drug prices only to have Speaker Nancy Pelosi put politics over progress. Now Speaker Pelosi is back at it—pushing a socialist proposal to appease her most extreme members. It does not have to be this way; there are bipartisan solutions to bring down prices for patients and create real transparency and accountability for this system,” said all 24 Republicans on the Energy and Commerce Committee.
- H.R. 1892, Bipartisan Budget Act, sped up the closing of the Part D ‘Donut Hole,’ reducing drug spending by seniors and sunsetting the exclusion of biosimilars from the Medicaid Part D coverage gap.
- H.R. 1839, Medicaid Services Investment and Accountability Act of 2019, established a civil monetary penalty for misclassifying covered outpatient drugs in Medicaid.
- H.R. 3253, Sustaining Excellence in Medicaid Act of 2019, excluding authorized generics from the calculation of average manufacturer price for purposes of the Medicaid drug rebate program.
- H.R. 1520, Purple Book Continuity Act of 2019, codifies requirements to list: name of biologic; date of licensing; studies necessary for biosimilar applications; updates every 30 days; patents disclosed during ‘patent dance’; and withdrawal or suspension of licensure. Requires FDA to report recommendations of what patents should be listed going forward.
- H.R. 1503, Orange Book Transparency Act of 2019, clarifies the information that FDA must include in the Orange Book about patents and exclusivities for approved drugs and clarifies that patents found to be invalid through a court decision or a decision made by the PTAB would be required to be promptly removed.
- H.R. 938, BLOCKING Act, makes the tentative approval of a subsequent generic drug applicant that is blocked solely by a first applicant’s 180-day exclusivity, where the first applicant has not yet received final approval, a trigger of the first applicant’s 180-day exclusivity.
- H.R. 965, CREATES Act, would penalize branded drug makers that withhold samples from generic manufacturers. Allows a biosimilar or generic drug manufacturer to bring an action in federal court to obtain samples of a reference product biologic or drug for the purposes of developing and seeking approval of a biosimilar or generic drug.
- H.R. 1499, Protecting Consumer Access to Generic Drugs Act of 2019, would ban pay-for-delay agreements. Prohibits brand name drug manufacturers and biological product manufacturers from compensating generic drug manufacturers and biosimilar manufacturers, respectively, to delay the entry of a generic drug or biosimilar into the market.
- H.R. 2296, METRIC Act, a key transparency legislation to improve manufacturers reporting of average sales prices, public disclosure of drug discounts, real-time benefits tools to lower beneficiary costs, etc.
- H.R. 1781, Payment Commission Data Act of 2019, would provide MedPAC and MACPAC drug rebate data and spending trends so they can provide cost recommendations to Congress.
- H.R. 34, the 21st Century Cures Act, accelerates the discovery, development, and delivery new cures and treatments.
- H.R. 2430, the FDA Reauthorization Act (FDARA) of 2017, ensuring the agency has the tools it needs to deliver safe and effective drugs, devices, and treatments to patients.
- For example, Republicans are the party that gave seniors more choice and more affordable drugs. Republicans are working with Democrats on new proposals to lower costs both for the seniors and for the Part D program and cap out-of-pocket spending to provide certainty to seniors that they will be protected should they need high-cost medications.