Senator’s Provisions to Combat Drug Shortages And Cut Red Tape for New and Innovative Medical Devices to Become Law
FDA Bill Also Includes Casey Measures to Help Develop New Antibiotics, Treatments for Diseases Affecting Children and Combat Prescription Drug Abuse
WASHINGTON, DC – U.S. Senator Bob Casey (D-PA) announced that Congress has passed a bipartisan bill to keep the Food and Drug Administration (FDA) fully functioning and is expected to be signed into law. The bill, the Food and Drug Administration Safety and Innovation Act, contains several provisions authored by Senator Casey that will increase medical protections for Pennsylvanians as well as bolster the state’s thriving medical sector.
Senator Casey’s provisions will ban dangerous drugs like bath salts, work to reduce deadly drug shortages, make it easier for innovative medical devices to come to market, aid researchers as they seek to develop new antibiotics, increase federal oversight of prescription drug abuse, and encourage the development of new treatments for rare and neglected diseases that disproportionately affect children.
“This legislation will protect the health of Pennsylvanians and help our thriving medical sector create jobs,” Senator Casey said. “One of the most important issues tackled in this bill is the shortage of lifesaving drugs. My drug shortage provision will work to prevent shortages before they start and ensure that Pennsylvanians can have access to the treatments they need.”
Senator Casey continued, “I am relieved that my effort to permanently ban bath salts and other synthetic drugs will finally be signed into law. Local law enforcement in Pennsylvania will now have new tools to protect our communities, which have faced horrible crimes and acts of violence as a result of these drugs.”
Every 5 years Congress must pass legislation to keep the FDA fully functioning. This year’s bill contains the following measures pursued by Senator Casey:
- Addressing drug shortages (S. 296, the Preserving Access to Life-Savings Medications Act):
The bill includes a Title on drug shortages, based upon S. 296, the Preserving Access to Life-Savings Medications Act, which Senator Casey introduced with Senator Klobuchar (D-MN) in February 2011. Senator Casey heard from scores of hospitals and patients in Pennsylvania affected by the recent shortages of drugs such as methotrexate, which is used to treat pediatric cancer. This bill will help to alleviate problems by giving FDA the authority and the tools it needs to help stop shortages before they occur by requiring drug companies to notify the FDA at least six months prior, or as soon as practicable, to a discontinuance or interruption that could lead to a meaningful disruption in the supply of the drug. The FDA prevented nearly 200 drug shortages in 2011 due to voluntary early notifications from companies, up from 38 in 2010.
- Ban on Synthetic Drugs Like Bath Salts
The bill will permanently ban 26 synthetic substances, including bath salts, under the Controlled Substances Act, and also double the length of time the DEA can temporarily ban substances to allow a permanent ban to take effect. Senator Casey was a leader in the effort to ban the harmful substances in bath salts and other synthetic drugs by pushing comprehensive legislation to deal with the problem. He also repeatedly urged the DEA to use its authority to get the drugs out of Pennsylvania communities. Senator Casey helped to secure a ban as part of the Senate FDA reauthorization bill, but the House-passed version of the FDA bill did not include the anti-drug provision. In a letter to Senate and House negotiators earlier this month, Senator Casey urged them to include the synthetic drugs provisions in the final bill.
- Speeding approval of novel medical devices (S. 2067, the Safe, Efficient and Transparent (SET) Medical Device Approval Act)
Senator Casey led one of the most important changes in the medical device agreement by reforming a process for review of new medical devices called the “de novo” pathway. The de novo pathway is used for review of low-to-moderate risk novel devices. Unfortunately, it has not worked well: a 2011 Institute of Medicine report found that, between 2005 and 2009, review times for novel therapeutic devices through the FDA de novo process nearly tripled and took more than two years on average. The final agreement incorporates S. 2067, a bipartisan bill Senator Casey introduced with Senator McCain (R-AZ), which streamlines the de novo pathway. Applicants will now have the ability to submit such devices directly to the de novo pathway without prior submission to FDA under the 510(k) pathway, which was not intended for novel devices. This is an issue of great importance to medical device companies in Pennsylvania.
- Creating incentives for development of antibiotics to counteract “superbugs”
Antibiotic-resistant infections are estimated to cost the U.S. health care system more than $20 billion annually and result in more than 8 million additional patient-days in the hospital. Despite this, only two new classes of antibiotics have reached the market in the past 30 years. These infections can also lead to death, ending the lives of even those who are otherwise in good health such as Ricky Lannetti, a 21-year old football player who attended college in Williamsport, PA, whose mother Theresa, visited Senator Casey’s office to call for legislative action on this issue. Senator Casey is pleased that key provisions of the bipartisan Generating Antibiotic Incentives Now (GAIN) Act, which he introduced with Senators Blumenthal (D-CT), Corker (R-TN) and others in October 2011, is included in final bill and promise to lead to greater pharmaceutical investment in this area.
- Combatting prescription drug abuse
According to the CDC, nearly three out of four prescription drug overdoses are caused by prescription painkillers, especially those known as opioid pain relievers. The unprecedented rise in overdose deaths in the U.S. parallels a 300% increase since 1999 in the sale of these strong painkillers. Senator Casey and Senator Alexander (R-TN) secured in the final package their bipartisan proposal, which requires a review of current federal initiatives and recommendations to better track and promote the safe use of medicines through better data collection at the federal level and enhanced coordination with prescription drug monitoring programs at the state level. The proposal would also require the FDA to announce within six months how it will review and approve new tamper-resistant products designed to prevent abuse.
- Spurring Development of Treatments for Neglected Diseases (the Creating Hope Act of 2011)
Senator Casey introduced the bipartisan Creating Hope Act of 2011 to encourage the development of new treatments for rare diseases that affect children. More than 20 million Americans have a rare disease, according to the National Organization for Rare Disorders, and children are most frequently and profoundly affected by these conditions. The legislation will strengthen a cost-neutral FDA program giving biopharmaceutical companies an incentive to develop treatments for rare diseases, such as pediatric cancer, that are often less profitable than treatments for more common medical conditions. The final bill includes a version of the original legislation, which creates a pilot program of three priority review vouchers, which FDA will award to drug sponsors that develop new treatments to help children with rare diseases.