Casey Proposals Pass Senate As Part of FDA Bill - Measures Will Protect Pennsylvanians, Boost Commonwealth’s Thriving Medical Sector

Senator’s Efforts to Combat Drug Shortages And Cut Red Tape for New and Innovative Medical Devices All Pass in Bill

FDA Bill Also Includes Casey Measures to Help Develop New Antibiotics, Combat Prescription Drug Abuse

WASHINGTON, DC – U.S. Senator Bob Casey (D-PA) announced that the Senate has passed a bipartisan bill to keep the Food and Drug Administration (FDA) operating. 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.

Casey’s provisions will 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 and increase federal oversight of prescription drug abuse.

“This FDA bill will protect the health of Pennsylvanians and help our thriving medical sector create jobs,” 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 drug shortages before they start and ensure that Pennsylvanians can have access to the treatments they need.”

Every 5 years Congress must pass legislation to keep the FDA operating. This year’s bill contains several measures pursued by Senator Casey:

  1. 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. Like the original legislation, the bill gives 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.

  1. 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. This is an issue of great importance to medical device companies in Pennsylvania.

  1. Creating incentives for development of antibiotics to counteract “superbugs”

Antibiotic drugs 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. Therefore, Senator Casey is pleased that a version of the bipartisan Generating Antibiotic Incentives Now (GAIN) Act, which he introduced with Senators Blumenthal (D-CT), Corker (R-TN) and others, is included in final bill.

  1. Combatting prescription drug abuse

According to the CDC, nearly three out of four prescription drug overdoses are caused by prescription painkillers—also called opioid pain relievers. The unprecedented rise in overdose deaths in the US 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 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 reveal within six months how it will review and approve new tamper-resistant products designed to prevent abuse.