WASHINGTON, D.C.-Today, the United States Senate Health, Education, Labor and PensionsCommittee passed The Biologics Price Competition and Innovation Act. The measure issponsored by Chairman Edward M. Kennedy, Senators Orrin Hatch, Hillary Clinton, Mike Enziand Charles Schumer. The legislation includes standards for the FDA to approve follow-onbiologics, a procedure designed to help resolve patents in an expedited way, and strong butresponsible incentives to encourage innovation and the development of new therapies.
Senator Kennedy said, “This bill reflects a balanced approach that enables patients to havesafe, effective and affordable biological drugs, while preserving the incentives that havebrought these life-saving advances to the American public. This century of the life sciencesoffers unlimited promise of new hope and new help for millions of patients. Congress has aresponsibility to encourage the innovation that leads to these new medical miracles, and tosee that they are affordable for the patients who need them. Our bipartisan legislation alsoincludes strong and responsible incentives to encourage dynamic new biotechnologycompanies to invest in the innovations that will produce the cures of tomorrow.""Biologics are the future of medicine, and this bill ensures that we will continue to lead theworld in biotechnology," Hatch said. "We've achieved a good balance. We give incentives tocontinue biological development. We allow generic companies to do what they do best - bringlow-cost versions to the market. And we ensure that patients and providers not only haveaccess to low-cost biologics but that they're also safe."
“This has real life, real world consequences. As soon as we enact this bill, there aremedications for Hepatitis C, multiple sclerosis, cancer and diabetes that will be available forgeneric versions that will be more affordable for many more people than currently is possible.With this committee’s action today, I am proud that we will both continue the creativity andinnovation that is absolutely essential to our pharmaceutical industry and the lifesavingtreatments and interventions they are able to provide for us and create a generic path that willbegin to lower prices and extend the availability of so many of these treatments to more whoneed them," said Senator Clinton.
“Biologics are the skyscrapers of the drug world. They are towering monuments to medicine,science and biotechnology that can’t easily be duplicated, and the slightest differences can befatal. Our bill recognizes the need to make sure that biologic therapies are both safe andaffordable," Senator Enzi said. “In addition, the legislation we’ve approved today holds newhope that we can further expand access of these remarkable medicines to more patients whoneed help. Biologics already are making it possible for thousands of Americans to liveproductive lives and changing the way we treat deadly diseases like cancer and infectiousdiseases."
"Giving the FDA authority to approve follow-on biologics is the first step to introducingcompetition into the market, and thus the first step to giving more people access to potentiallylife-saving drugs," said Senator Schumer. “This bill represents a solid compromise and showsthe great strides we can make when working together, even on very complicated issues likebiologics."
The bill gives the FDA the flexibility it needs to apply the latest scientific advances in theregulatory process, so that new follow-on products will be safe and effective. The bill alsogives the FDA the flexibility to adapt to changes in scientific knowledge and does not freeze inplace an inflexible regulatory structure.
A summary of the bill is below.
