Durbin, Cassidy Introduce REMEDY Act To Lower Drug Prices By Curbing Patent Manipulation, Promoting Generic Competition
WASHINGTON – U.S. Senators Dick Durbin (D-IL) and Bill Cassidy, M.D. (R-LA) today introduced a bipartisan bill to tackle the pharmaceutical industry’s practice of gaming the patent system to extend monopolies on lifesaving drugs. The Reforming Evergreening and Manipulation that Extends Drug Years (REMEDY) Act, would lower prescription drug prices and promote competition by removing barriers to Food and Drug Administration (FDA) approval for lower-cost generic drugs. Many high-cost, brand-name drugs are shielded from competition because of the ability to manipulate the system by “evergreening” or filing numerous additional patents to their product in an attempt to forestall generic competition. The REMEDY Act would crack down on these abusive pharmaceutical monopolies and lower costs for patients.
“Americans are facing skyrocketing prescription drug costs in part because brand-name pharma manufacturers have gamed the patent system to extend their monopolies and avoid competition from lower-cost generic drugs. That doesn’t promote innovative research and it’s not serving the best interests of patients,” Durbin said. “The REMEDY Act will increase competition and help reduce drug costs by curbing patent manipulation by brand name drug makers. This common sense bipartisan legislation is overdue, and I hope my colleagues will join Senator Cassidy and me in supporting it.”
“No matter where I go in Louisiana people are always mentioning the high cost of prescription drugs,” said Dr. Cassidy. “To lower the cost of drugs we need to increase competition. Getting generics to market faster increases access and saves money for patients and taxpayers.”
The top 12 best-selling drugs in the United States each have an average of 71 patents, and their prices have increased by an average of 70 percent over the last five years. In fact, 74 percent of all new drug patents are for drugs already on the market—extending monopolies well-past the 20-year patent term. The bulk of these patents are for secondary purposes, such as the method of use or formulation (e.g., pill coating), which may not add to the drug’s efficacy or safety.
The REMEDY Act amends FDA statute to remove incentives for drug manufacturers to file excessive patents, and would lift onerous legal barriers that delay generic market entry. Under this policy, once the substance patent and all exclusivities expire, generic manufacturers would be allowed to enter the market more easily. The REMEDY Act also increases transparency and removes hurdles for generic drug companies by ensuring that when a patent is invalidated by a ruling at the U.S. Patent and Trademark Office, and upheld on appeal, the FDA’s listing of relevant drug patents would be updated.
The bipartisan REMEDY Act is endorsed by the Campaign for Sustainable Rx Pricing.