WASHINGTON -- June 20, 2012 -- The U.S. House of Representatives today is scheduled to consider legislation that would work to combat future drug shortages, maintain patient access to critical pain medications, and strengthen the patient voice as part of an effort to reauthorize and expand the industry-supported user fee program that pays for the expeditious review of new pharmaceutical drugs and medical devices by the Food and Drug Administration (FDA). The Senate is scheduled to vote on the same legislation next week.
A statement from American Cancer Society Cancer Action Network (ACS CAN) President Christopher W. Hansen follows:
Families affected by cancer are encouraging Congress to approveæ legislation that has the potential to make a significant difference in the lives of patients, providing them with timely access to cutting edge treatments and therapies through reauthorization and expansion of a critical industry-government partnership. Industry user fees are critical to enable the Food and Drug Administration (FDA) to continue to speed approval of lifesaving cancer drugs and treatments.
The user fee legislation includes provisions aimed at mitigating the ongoing drug shortage problem in the United States, which has been experienced first-hand by cancer patients and survivors who have been denied access to lifesaving drugs that are in short supply.æ The bill directs manufacturers to provide FDA with early notification of a prospective discontinuation or interruption in the drug manufacturing process that could lead to a shortage of a particular drug.æ It also establishes an FDA task force to work with the Secretary of Health and Human Services to create a strategic plan that promotes interagency coordination in an effort to avert or mitigate drug shortages. The task force would engage manufacturers, as necessary, to ensure the availability of alternative sources of drug supply in the case of an ongoing or prospective shortage.
ACS CAN and the American Cancer Society have been working with the FDA and representatives of the pharmaceutical industry for many months to find a solution to a problem that has directly impacted cancer patients. These steps, coupled with a new generic drug user fee, are a good start that will begin to alleviate some of the current drug shortages.
ACS CAN successfully urged lawmakers to reject an earlier proposal to reclassify Hydrocodone, a medication frequently used to treat pain related to cancer, in a way that would have made the drug more difficult for patients to get. The proposal was intended to curb abuse by illegal users of the drugs, but it would have had the unintended consequence of creating barriers to care for many patients and survivors who are often prescribed these medications to complete their disease-directed treatments, sleep through the night, or continue to work and otherwise engage in and enjoy activities of daily life. Instead, the final version of the bill includes a more measured approach that requires the FDA to examine the use of Hydrocodone and evaluate appropriate classification of the medication.
Additionally, the bill recognizes the value that patients bring to the drug review process, requiring the Secretary of Health and Human Services to implement strategies that will allow the FDA staff to better identify patients eligible to participate in appropriate agency meetings with medical product sponsors and investigators and provide the patient perspective. Having experienced treatment personally, patients bring a unique perspective on the benefit and risks of new drug therapies.
ACS CAN worked hard to ensure that provisions included in the user-fee legislation addressed drug shortages, maintained access to critical pain care and enhanced patient participation in the drug review process. Cancer patients, survivors and their loved ones call on the House and Senate to quickly pass this important legislation and send it to the President for his signature.
The user free reauthorization legislation also includes permanent reauthorization of the Best Pharmaceuticals for Children Act (BPCA) and Pediatric Research Equity Act (PREA), two laws that have advanced pediatric research since they were first authorized in 2002 and 2003 respectively. The legislation strengthens the FDA's authority to evaluate the effectiveness of drug therapies for children, requiring better communication between FDA and the drug manufacturer earlier in the drug approval process.
Finally, the law includes reauthorization of the Medical Device User Fee Act (MDUFA), a program that since its inception has resulted in significant improvements in the device review program and saved countless number of lives of cancer patients.
ACS CAN, the nonprofit, nonpartisan advocacy affiliate of the American Cancer Society, supports evidence-based policy and legislative solutions designed to eliminate cancer as a major health problem. ACS CAN works to encourage elected officials and candidates to make cancer a top national priority. ACS CAN gives ordinary people extraordinary power to fight cancer with the training and tools they need to make their voices heard. For more information, visit www.fightcancer.org.
For More Information, Contact:
Alissa Crispino or Steven Weiss
American Cancer Society Cancer Action Network
Phone: 202-661-5772 or 202-661-5711
Email: [email protected] or [email protected]
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