HOUSTON, TX — In response to the unanimous vote by the Energy and Commerce Committee to advance six drug pricing bills after bipartisan agreement, Mark E. Miller, Executive Vice President of Health Care at Arnold Ventures, issued the following statement:
“The action taken yesterday by the Energy and Commerce Committee is positive but can only be seen as a small first step. The bills passed, such as the CREATES Act and legislation to end pay-for-delay tactics, largely address anticompetitive behaviors. And while these reforms are important, Congress must pass comprehensive legislation to deliver lower prices at the pharmacy counter for Americans. A comprehensive package should include measures to end anticompetitive behaviors. But it also needs to address market distortions, such as the existing rebate system, and deliberately reduce launch prices and price increases.”
The Committee passed the following drug pricing bills:
H.R. 1781, the “Payment Commission Data Act of 2019,” introduced by Reps. Buddy Carter (R-GA), Tom O’Halleran (D-AZ), Tom Rice (R-SC), Jimmy Panetta (D-CA), Greg Gianforte (R-MT), and Peter Welch (D-VT), provides the Medicare Payment Advisory Commission (MedPAC) and the Medicaid and CHIP Payment and Access Commission (MACPAC) with access to drug pricing and rebate data in order for these independent, nonpartisan commissions to help Congress better understand the true costs of prescription drugs to consumers and taxpayers.
H.R. 938, the "Bringing Low-cost Options and Competition while Keeping Incentives for New Generics (BLOCKING) Act of 2019," introduced by Reps. Kurt Schrader (D-OR) and Buddy Carter (R-GA), would discourage parking of 180-day exclusivity by a first generic applicant that is blocking the approval of other generics.
H.R. 1520, the "Purple Book Continuity Act of 2019," introduced by Rep. Anna G. Eshoo (D-CA), would codify publication of the patents 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.
H.R. 1503, the "Orange Book Transparency Act of 2019," introduced by Rep. Robin 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. 1499, the "Protecting Consumer Access to Generic Drugs Act of 2019," introduced by Rep. Bobby 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. 965, the "Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019," introduced by Reps. David Cicilline (D-RI), Jim Sensenbrenner (R-WI), Jerrold Nadler (D-NY), Doug Collins (R-GA), Peter Welch (D-VT), and David McKinley (R-WV), would establish a process by which generic manufacturers could obtain sufficient quantities of brand drug samples for testing thereby deterring gaming of safety protocols that brand manufacturers use to delay or impede generic entry.