At Boyt Drugs, an independent pharmacy in Metuchen, U.S. Rep. Frank Pallone, D-6th District, unveiled on Monday several policy solutions that he said would help encourage generic drugs and greater competition in the marketplace.
Pallone, chairman of the Energy and Commerce Committee, is in the process of advancing numerous bills designed to lower the cost of prescription drugs.
“The price of prescription drugs has skyrocketed in the last few years. It’s the number one issue that people talk to me about,” Pallone said. “If we don’t start doing something to lower the price of prescription drugs we are going to see more and more people who need them who are not going to have them.”
“We are going to move legislation in the energy and commerce committee that will come to the floor in the House of Representatives that addresses one aspect of the prescription drug industry and one way of trying to deal with the problem of high cost and that is generic competition.”
Pallone said that a few years ago, his committee took steps to bring generic drugs to market and people recognized the value of generics as a way of bringing down costs.
“But unfortunately because the brand name companies have stepped in and done certain things, generics have not become as competitive and have not been as much of a factor in lowering the cost of prescription drugs as they could be. Part of what we are doing with these bills is to bring back generics as a major way of trying to lower costs by making generics more viable,” Pallone said.
Pallone has several bills pending, including:
House Resolution 965, CREATES of 2019: The CREATES Act focuses on deterring brand drug manufacturers from using restricted distribution systems— including safety protocols known as REMS—to delay or impede generic competition on both the front end of generic drug development and the back end of market entry. The bill would allow a generic manufacturer facing delay tactics to bring an action in federal court to obtain the samples it needs.
House Resolution 985, the FAST Generics Act: Focuses on deterring brand drug manufacturers from using REMS and other restricted distribution systems to delay generic competition on the front end of generic drug development and the back end of market entry.
House Resolution 1499, Protecting Consumer Access to Generic Drugs Act of 2019: This legislation would make it illegal for brand name and generic drug manufacturers to enter into anti-competitive agreements in which the brand-name drug manufacturer pays the generic manufacturer to keep more affordable generic equivalents off the market.
House Resolution 938, BLOCKING Act of 2019: This legislation strives to discourage taking undo advantage 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: the subsequent application is ready for full approval; a minimum of thirty months has passed since at least one first applicant submitted their application for the drug; any related patent litigation has been fully resolved; and no first applicant is approved.
House Resolution 1506, Fair and Immediate Release (FAIR) of Generic Drugs Act: This legislation attempts to disincentivize both taking advantage of 180-day exclusivity by a first generic applicant and patent settlement agreements that delay commercial marketing. It would do so by allowing any generic filer who wins a patent challenge in court or is not sued for patent infringement by the brand company to share in the 180-day exclusivity period of a first applicant.
House Resolution 1503, Orange Book Transparency Act of 2019: The Orange Book is an interactive, electronic database of all approved drugs and their relevant patents and exclusivities. This book is often relied upon by generic manufacturers in making development decisions. This legislation 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 so that the agency can maintain an accurate Orange Book, as well as ensuring that patents listed in the Orange Book are relevant to the drug product.
House Resolution 1520, Purple Book Continuity Act of 2019: The Purple Book is a less transparent and, ultimately, less helpful data source of the patents and exclusivities related to biologics. The bill 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.
Pallone said that these bipartisan bills will lower costs for consumers by removing barriers to competition that prevent cheaper generic drugs from coming to market. He added that preventing companies from gaming market loopholes is a commonsense approach to reduce costs for consumers right away.