SENATORS KENNEDY, HATCH, CLINTON, ENZI ANNOUNCE FDA BIOLOGICS AGREEMENT
WASHINGTON, D.C— Today, Senators Kennedy, Hatch, Clinton, and Enzi announced anagreement on legislation authorizing the FDA to approve a follow-on version of biologictherapies. The legislation includes standards for the FDA to approve follow-on biologics, amechanism to resolve patents in an expedited way, and strong but responsible incentives toencourage innovation and the development of new therapies. A summary of the legislation willfollow.
Senator Kennedy said, "This century of the life sciences offers unlimited promise of new hopeand new help for millions of patients. Congress has a responsibility to encourage theinnovation that leads to these new medical miracles, and to see that they are affordable forthe patients who need them. The bipartisan legislation we announce today achieves these twoimportant goals. Just as generic drugs have helped bring down the costs of medicines formillions of Americans, new "follow-on" versions of breakthrough biologics will make theseinnovative treatments more affordable for the patients who need them. Our bipartisanlegislation also includes strong and responsible incentives to encourage dynamic newbiotechnology companies to invest in the innovations that will produce the cures of tomorrow.Our legislation also includes strong safeguards to ensure patient safety.”Senator Hatch said, “It’s crucial that Congress get this right because biologics are the future ofmedicine. It’s taken a lot of effort, but we’ve achieved a good balance in this bill. Just as wedid with Hatch-Waxman in 1984, we’re giving incentives for both pioneer and generic drugfirms. We’re ensuring that we continue to get the latest medical breakthroughs while creatinga clear pathway to get less expensive biologics on the market quickly.”
Senator Clinton said, "Allowing generic versions of biologic drugs will help fulfill the promise ofthese cutting-edge medicines. By breaking the pharmaceutical industry’s monopoly on thesemedications, we will improve healthcare and reduce costs dramatically for seniors, familiesand employers. We will stretch precious healthcare dollars further in Medicare and Medicaid.And we will enable more Americans access to affordable treatments that could improve oreven save their lives. This is truly a win-win for consumers and our country."
Senator Enzi said, “This legislation captures a delicate balance between access and innovationwhile maintaining the highest standard of safety. I predict that very shortly, SenatorsKennedy, Hatch, Clinton, and I will look back at this legislation with great pride, as it will beseen as a vital part of insuring our aging population has access to innovative, reliable, andsafe medicines. 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. The agreement we’ve reached today holds new hope that we can further expandaccess of these remarkable medicines to more patients who need help combating deadlydiseases.”