Hearing on “Improving Drug Pricing Transparency and Lowering Prices for American Consumers”
The Health Subcommittee held a legislative hearing on Tuesday, May 21, at 10:30 am in the John D. Dingell Room, 2123 of the Rayburn House Office Building. The hearing is entitled, “Improving Drug Pricing Transparency and Lowering Prices for American Consumers."
Memorandum from Chairman Pallone to the Subcommittee on Health
Opening Statement of Chairman Pallone as prepared for delivery
Opening Statement of Subcommittee Chairwoman Eshoo as prepared for delivery
H.R. 2296, the "Fair Accountability and Innovative Research Drug Pricing Act", Reps. Schakowsky (D-IL) and Rooney (R-FL) requires certain drug manufacturers to submit documentation to the Secretary of the Department of Health and Human Services (HHS) 30 days before increasing the price of a qualifying drug. The bill requires manufacturers to report their justification for an increase in the wholesale acquisition cost (WAC) of a qualifying drug should the manufacturer decide to increase the price by 10 percent or more over a 12-month period, or by 25 percent or more over a 36-month period. A manufacturer of a qualifying drug would be required to report the total expenditures for manufacturing the drug, the research and development expenditures for the qualifying drug, and total revenue and net profit generated by the drug, as well as other documentation as applicable. H.R. 2296 would require that the information provided by the manufacturer be published unless it is considered trade secret and confidential. This legislation includes a civil monetary penalty of $100,000 per day should a manufacturer fail to comply. Annual reports of this information are also required to be provided by HHS to Congress.
H.R. 2069, the "Stopping the Pharmaceutical Industry from Keeping drugs Expensive Act", Reps. Horsford (D-NV) and Reed (R-NY), requires certain drug manufacturers to submit to the Secretary of HHS documentation justifying: (1) a 10 percent or $10,000 dollar increase with respect to WAC of any applicable drug over any 12-month period; (2) a 25 percent or $25,000 dollar increase with respect to WAC over any 36-month period; or (3) a drug that is estimated to cost at least $26,000 a year or per course of treatment. If the Secretary of HHS determines that a manufacturer’s drug product would meet one of these criteria, the manufacturer is required to submit certain information, including total expenditures on research and development, as well as revenue and profit for the applicable drug. A summary of the manufacturer’s justification would then be published onto the website of the Centers for Medicare and Medicaid Services (CMS).
H.R. 2087, the "Drug Price Transparency Act", Reps. Doggett (D-TX) and Buchanan (R-FL), requires all manufacturers to report ASP data to CMS for all drugs covered under Medicare Part B, authorizes civil money penalties against manufacturers who fail to report the data or report false data, and improves oversight related to the accuracy of the ASP data reported.
H.R. 2115, the "Public Disclosure of Drug Discounts Act", Reps. Spanberger (D-VA), Arrington (R-TX), and Boyle (D-PA), requires PBMs to disclose the aggregate amount of rebates, discounts, and price concessions that PBMs negotiate with drug manufacturers, and make this information publicly available to allow the public to compare the aggregate rebates, discounts, and price concessions that PBMs receive.
H.R. 2064, To amend title XI of the Social Security Act to require manufacturers of certain drugs, devices, biologicals, and medical supplies to report on product samples provided to certain health care providers, and for other purposes.
H.R. 2376, the "Prescription Pricing for the People Act", Reps. Nadler (D-NY) and Collins (R-GA), would require the Federal Trade Commission (FTC) to conduct a study on the state of competition in the drug supply chain. This study would focus on whether PBMs have engaged in any anti-competitive practices, such as steering patients to pharmacies for anti-competitive purposes, giving such pharmacies more favorable rates than it offers to competing pharmacies, or using its market power to depress the use of lower-cost prescription drugs. The bill also requires that the FTC provide policy recommendations for how to improve transparency and competition in the pharmaceutical supply chain.
H.R. 2757, the "Creating Lower cost Alternatives for Your prescription drugs Act", Reps. Cunningham (D-SC) and Bilirakis (R-FL), eliminates copayment requirements for generic drugs for Part D beneficiaries who receive low-income subsidies (LIS). This bill reduces cost-sharing for generic drugs to $0 for beneficiaries with income below 150 percent of the poverty line and seeks to incentivize the use of available, higher value products among these beneficiaries.
Senior Vice President, Insurance and State Issues
Pharmaceutical Research and Manufacturers of America
Chief Policy and External Affairs Officer
Pharmaceutical Care Management Association
President, Coalition of State Rheumatology Organizations
Alliance of Specialty Medicine
Executive Vice President of Health Care
American Action Forum