Following Record Drug Recalls and Shortages, Bennet Helps Pass FDA Reform in Senate Bill Includes Bennet’s Drug Innovation, Drug Safety, Medical Device Provisions to get Safe and Effective Treatments to Colorado Patients
BigNews.Biz - May 27,2012 - Following Record Drug Recalls and Shortages, Bennet Helps Pass FDA Reform in Senate
Bill Includes Bennet’s Drug Innovation, Drug Safety, Medical Device Provisions to get Safe and Effective Treatments to Colorado Patients
Work Continues on Track and Trace; Mobile Apps
Colorado U.S. Senator Michael Bennet helped push through passage of a bill in the Senate to modernize the Food and Drug Administration.
The bill contains a number of policy provisions aimed at improving the safety of pharmaceutical drugs and medical devices and the speed in which they are available for patients and families in Colorado and across the country. The FDA Safety and Innovation Act passed the Senate with broad bipartisan support by a vote of 96-1.
The United States is currently facing critical drug shortages and drug recalls that can hurt patients who need treatment the most. In Colorado Springs, drug shortages have forced doctors at Penrose-St. Francis Hospital to delay therapy for some leukemia patients and to substitute less effective antibiotic medications for those that are in short supply. In 2010, Colorado Children’s Hospital flagged a problem with tainted sterile alcohol wipes that were tied to several cases of people becoming suddenly ill, including a 10-year-old Glenwood Springs boy and the death of a 2-year-old Houston boy.
“Parents in Colorado and across the country want to know that the drugs in their medicine cabinet will help, not harm their kids,” Bennet said. “This bill changes a number of antiquated regulations to improve the safety and quality of the drugs and therapies Coloradans use every day. It also will help get new life-saving treatments to patients faster and support innovation in our health IT and bioscience sectors, which are growing in Colorado. Chairman Harkin and Ranking Member Enzi showed incredible leadership in guiding this bill through the Senate, and I am confident that we will be able to get a bill to the president’s desk for his signature.”
Bennet’s work on the bill was born out of numerous discussions with doctors, patients, families, and other stakeholders who detailed their stories about why FDA regulations need updating. During the markup of the bill in the Senate Committee on Health, Education, Labor and Pensions (HELP), Bennet successfully secured provisions to improve drug safety, bring breakthrough treatments to patients more quickly, advance medical device innovations and prevent critical drug shortages.
Additionally, Bennet is continuing to work on two additional provisions as the bill moves toward a conference committee. He continues to work with FDA to reach consensus on regulations for medical mobile apps that foster innovation and protect patient safety. He also worked with Harkin, Enzi and Senator Richard Burr of North Carolina to include placeholder language in the bill to establish a uniform, national traceability framework. The language allows for continued discussions on this policy as Congress works toward a final FDA user fee bill.
Drug Safety
The drug safety component of the bill enhances the ability of the FDA and increases oversight of the pharmaceutical industry to ensure U.S. prescription
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