NEWARK, Del. – Today, July 5, 2012, U.S. Sen. Tom Carper (D-Del.) joined local stakeholders to celebrate the passage of the Food and Drug Administration Safety and Innovation Act (FDASIA) at the Helen F. Graham Cancer Center at Christiana Care Health System in Newark, Del.
FDASIA reauthorizes the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee Act (MDUFA); creates new user fee programs for biologic drugs and generic drugs; improves the development of drugs and medical devices especially for children; and establishes new programs to reduce drug shortages and encourage the development of new antibiotics to fight drug-resistant pathogens.
"This law helps ensure that Americans get access to the life-saving medications and medical devices that are developed in this country – including Delaware – as soon and as safely as possible," said Sen. Tom Carper. "It improves the Food and Drug Administration's ability to review and regulate drugs and medical devices for adults and children. This legislation also helps to protect patients' access to critical medicines by creating new programs to incentivize the development of new antibiotics and reduce drug shortages. Patients, health care providers, and the pharmaceutical and medical device industries will all benefit from a more responsive and effective Food and Drug Administration– a win-win for Delaware consumers and businesses."
The final version of PDUFA includes several key provisions of Congressman John Carney's Drug Shortage Prevention Act, including:
- Expedited review of any application seeking approval of a critical drug and any request by a manufacturer of a critical drug to approve a change to the manufacturing process or facilities of that drug in order to mitigate or prevent a shortage.
- Improved regulation of critical drugs to ensure that, at each stage of the regulatory process, the status of drugs as critical drugs is taken into consideration.
- Development of improved communications protocol between offices within FDA responsible for approving and regulating critical drugs and offices of FDA responsible for identifying and addressing critical drug shortages.
- Requirement that FDA communicates any new regulatory concern identified about a critical drug to the office within FDA responsible for identifying and addressing critical drug shortages.
"Every American should have access to the critical drugs they need to stay healthy and fight deadly diseases," said Congressman Carney. "The changes I proposed that were incorporated into this legislation ensure that more of these critical drugs are produced safely and reach the doctors and patients who need them. This bill will reduce drug shortages across America and improve the quality of care patients receive. I look forward to President Obama officially signing it into law."
"My colleagues and their patients are confronted every day with prescription drug shortages that are life-threatening and expensive," said Dr. Nicholas Petrelli, the Bank of America-endowed Medical Director of Christiana Care Health System's Helen F. Graham Cancer Center. "Our patients are in dire need of relief from this problem but thankfully this bill takes meaningful steps to deal with this crisis. We greatly appreciate Congressman Carney and the delegation's hard work on this critical issue."
"We share Sen. Carper's confidence that passage of the FDA Safety and Innovation Act has the potential to further accelerate the development and review of important new medicines that address the needs of patients and the physicians who treat them," said Paul Friedman, M.D., President and Chief Executive Officer of Incyte Corporation, a Wilmington, Delaware-based biopharmaceutical company focused on the discovery, development and commercialization of proprietary small molecule drugs for oncology and inflammation.
"We are truly grateful for the efforts of Delaware's Congressional Delegation on behalf of all people living with diabetes, especially the estimated 57,000 in the State of Delaware," said Theresa Haenn, Executive Director of the Eastern PA/Delaware Chapter of JDRF, the world's leading type 1 diabetes research funder. "As a result of this bill, the FDA will be in a position to streamline the approval process of products to improve access to safe, effective and potentially lifesaving therapies. This bill, along with a strong collaboration between JDRF and the FDA, helps to pave the way for medical device technology such as the artificial pancreas to advance through the FDA regulatory process. We know that the FDA Safety and Innovation Act is a major step forward in bringing new type 1 diabetes therapies to patients so they can remain strong and healthy for the time when a cure is found."
"The passage of the FDA Safety and Innovation Act is an important step in the journey to improve the access, safety and efficacy of drugs and medical devices. This is a critical issue for all patients, but is especially important for the nation's children, who are among the most vulnerable," said Dr. E. Anders Kolb, Director of the Nemours Center for Cancer and Blood Disorders at the Alfred I. duPont Hospital for Children.