Hearing on “Lowering the Cost of Prescription Drugs: Reducing Barriers to Market Competition”
The Health Subcommittee held a legislative hearing on Wednesday, March 13, at 10 am in the John D. Dingell Room, 2123 Rayburn House Office Building. The hearing is entitled, “Lowering the Cost of Prescription Drugs: Reducing Barriers to Market Competition.”
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. 938, the "Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019," introduced by Reps. Schrader (D-OR) and Carter (R-GA), would discourage parking of 180-day exclusivity by a first generic applicant by allowing FDA to approve a subsequent generic application prior to the first applicant’s first date of commercial marketing when the following four conditions have all been met: (1) the subsequent application is ready for full approval; (2) a minimum of 30 months has passed since at least one first applicant submitted their application for the drug; (3) any related patent litigation has been fully resolved; and (4) no first applicant is approved.
H.R. 965, the "Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019," introduced by Reps. Cicilline (D-RI), Sensenbrenner (R-WI), Nadler (D-NY), Collins (R-GA), Welch (D-VT), and McKinley (R-WV), would establish a process by which generic manufacturers could request that FDA authorize them to obtain sufficient quantities of samples for testing.
H.R. 985, the "Fair Access for Safe and Timely (FAST) Generics Act of 2019," introduced by Reps. Welch, McKinley, and Cicilline, establishes an authorization process by which generic manufacturers can gain access to samples of approved drug products that they are trying to genericize.
H.R. 1499, the "Protecting Consumer Access to Generic Drugs Act of 2019," introduced by Rep. Rush (D-IL), would make it illegal for brand-name and generic drug manufacturers to enter into agreements in which the brand-name drug manufacturer pays the generic manufacturer to keep a generic equivalent off the market.
H.R. 1503, the "Orange Book Transparency Act of 2019," introduced by Rep. Kelly (D-IL), would help to ensure that the Orange Book is accurate and up-to-date, by requiring manufacturers to share complete and timely information with FDA, as well as ensuring that patents listed in the Orange Book are relevant to the approved drug product. Patents found to be invalid through a court decision or a decision by the Patent Trial and Appeal Board would be required to be removed promptly.
H.R. 1506, the "Fair and Immediate Release (FAIR) of Generic Drugs Act," introduced by Rep. Barragán (D-CA), would allow any generic filer who wins a patent challenge in court or is not sued for patent infringement by the brand manufacturer to share in the 180-day exclusivity period of first applicants that enter into patent settlements that delay entry.
H.R. 1520, the "Purple Book Continuity Act of 2019," introduced by Subcommittee Chair Eshoo (D-CA), would amend the Public Health Service Act to codify publication of approved biological products in the Purple Book in a similar format and with similar requirements to the Orange Book, specify that the Purple Book should be published electronically on FDA’s website and updated routinely, and direct FDA to consider the types of patents that should be listed in the Purple Book.
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National Health Council
Chester “Chip” Davis, Jr.
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Association for Accessible Medicines (AAM)