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WASHINGTON, D.C. – Three members of the U.S. House today introduced legislation that would lower the skyrocketing costs of prescription drugs by increasing the availability of generic drugs. U.S. Representatives Henry A. Waxman (CA-30), Frank Pallone (NJ-06), and Rosa L. DeLauro (Conn.-3) introduced the Lower Prices Reduced with Increased Competition and Efficient Development of Drugs Act (the Lower PRICED Drugs Act) to remove current roadblocks that prevent generic alternatives from entering the market. According to the Congressional Budget Office, generic drugs save consumers an estimated $8 to $10 billion a year at retail pharmacies. Even more billions are saved when hospitals use generics.
“We've made tremendous progress in getting generic drugs to the market since the original passage of the Hatch-Waxman bill, but we still have more to do,” said Rep. Waxman. “This bill will continue the process of tightening provisions in the law that the brand-name companies have exploited to increase their profits by delaying the entry of generic drugs on the market. And every day of delay means higher drug costs for the American public.”
“Generic drugs have played a crucial role in lowering costs and improving access to life saving medicines,” Pallone said. “Unfortunately, for years brand name drug makers have exploited loop holes in current law to keep these drugs off of the market to protect their bottom line. Our legislation will help close these loopholes so Americans have better access to the affordable medications they need to live healthier lives.”
“Whether you are caring for elderly parents, raising a family or providing for your own health care needs, every American has been affected by the high cost of prescription drugs,” said DeLauro. “Generic alternatives for brand name drugs have the potential to slow the rising price of prescription drugs. It should be good news that FDA’s Office of Generic Drugs is receiving a substantial number of new applications and we could provide even better news if we remove the roadblocks that are preventing these critical alternatives from entering the market.”
The Lower PRICED Drugs Act will:
Give FDA the authority it needs to approve generic versions of certain antibiotics;
Give courts greater discretion to shorten the 30 month stay of a generic drug approval prompted by a patent infringement lawsuit;
Eliminate the windfall profits awarded to brand-name companies for conducting pediatric studies of their drugs; and
Rein in abuse of FDA’s citizen petition process by brand-name drug companies seeking to delay generic entry.
Similar legislation was introduced in the U.S. Senate by Debbie Stabenow (D-MI) and Trent Lott (R-MS). |
