Congressional Staff Point to Legislative Reform Options to Combat Increasing Shortage
WASHINGTON, April 24, 2012 /PRNewswire-USNewswire/ -- The National Patient Advocate Foundation (NPAF), in collaboration with the Friends of Cancer Research (FOCR) and 50 national non-profit patient advocacy Regulatory Education and Action for Patients (REAP) member organizations, today convened a briefing on Capitol Hill to showcase the patient perspective on the national drug shortage crisis affecting patients' access to cancer drugs, anesthetics and other essential medications.* The offices of Senator Amy Klobuchar (D-MN), Representative John Carney (D-DE), Representative Diana DeGette (D-CO) and the Senate Finance Committee were all represented at today's briefing to address the current legislative agenda surrounding the crisis.
Drug shortages place a severe physical, psychological and emotional impact on patients with life threatening conditions and debilitating diseases. "Nearly every day there is a story in the news about these drug shortages. For me and thousands of others, this is personal. Had I been able to get Doxil last fall, my ovarian cancer would be in remission and I would not have to juggle both ovarian and breast cancers," said Carey Fitzmaurice, a mother of two young sons who cannot access Doxil, a drug treatment for ovarian cancer. "Those of us experiencing critical drug shortages are in crisis and the solution to ending that crisis is out of reach."
In 2011, there were over 230 drug shortages in the United States. The Obama Administration has recognized the impact these shortages have on important clinical trials and life-saving treatments and is actively taking steps to address the problem. Last fall, the Administration issued an executive order to the Food and Drug Administration (FDA) calling for further reporting on the potential shortages of prescription drugs and enhanced coordination with the Department of Justice to determine if drug wholesalers are stockpiling or increasing medication prices to gouge consumers.
Industry, physicians, patients and political stakeholders agree that more needs to be done to eliminate the shortage and restore stability in the therapeutic drug market. "My 21-year-old daughter depends upon IV-administered Phenergan every four hours around the clock for her severe and chronic nausea, and unfortunately this drug is on the shortage list," said Shelah Bechtel, a registered nurse from Toledo, Ohio. "With my experience as a nurse and in learning about patient advocacy, I have been able to secure this vital medication for her, after much legwork – but not every patient or parent is going to have the know-how needed to track down their essential medicines."
Several members of Congress represented at today's briefing have developed legislative proposals to address the growing drug shortage crisis. The Preserving Access to Life-Saving Medications Act, introduced in the Senate by Senators Amy Klobuchar (D-MN) and Bob Casey (D-PA) and in the House by Representatives Diana DeGette (D-CO) and Tom Rooney (R-FL) calls for major overhauls to improve communications to and from the FDA.
Senator Klobuchar helped create a bipartisan drug shortages agreement that will be considered by the Senate Health, Education, Labor and Pensions Committee in upcoming legislation. The agreement includes a key provision of the Preserving Access to Life-Saving Medications Act that requires early notice be given to the FDA by prescription drug manufacturers as to any incident that may result in shortage. "Patients' energy should be focused on getting well - they shouldn't be burdened with the added stress and worry of whether or not they will have enough medicine to treat their condition tomorrow," Klobuchar said. "This bipartisan agreement would give the FDA important early warning tools to help prevent drug shortages before they occur. I will continue to work to move this plan forward as quickly as possible so we can stop these shortages from wreaking havoc on families' lives."
"Patients' health is too important to suffer the consequences of a drug shortage simply because of a lack of communication between stakeholders," Congresswoman Diana DeGette stated. "That is why this bill (Preserving Access to Life-Saving Medications Act) requires timely reporting of information on any possible interruption that could result in changes to production, and stipulates the [Health and Human Services] Secretary publish shortage notifications on its website as well as distribute the information to providers and patient organizations."
On January 31, 2012, Congressmen John Carney (D-DE) and Larry Bucshon (R-IN) introduced the Drug Shortage Prevention Act. If enacted, key components of the legislation will require the FDA to identify drugs prone to shortage and mandate their expedited review and approval, necessitate better communication between FDA regulatory staff and drug shortages staff, and call on the FDA to notify distributors of a potential shortage and develop a system to alert the public when a new drug is placed on the shortage list.
"Since 2005, the number of drug shortages in the United States has quadrupled, and cancer patients have been disproportionately impacted by this troubling trend," said Congressman John Carney. "We must ensure that Americans have access to the critical drugs they need to stay healthy and fight back against deadly diseases. The Drug Shortage Prevention Act brings more efficiency to the manufacturing and distribution processes and requires the FDA to take action to prevent drug shortage problems before they begin impacting patients."
Dr. Marc Stewart, a member of the Scientific Board at the National Patient Advocate Foundation, joined the dialogue in Washington when he spoke at the FDA Public Hearing on Drug Shortages in September 2011.
"Drug shortages present a significant access barrier to patients receiving life saving care," said Nancy Davenport-Ennis, CEO and Founder of the National Patient Advocate Foundation/Patient Advocate Foundation. "As evidenced by the multitude of people experiencing lack of treatment, it's important that Congress work together to enact life-saving legislation."
The briefing concluded with the release of the Patient Advocate Foundation's annual Patient Data Analysis Report (PDAR). In 2011, PAF served 103,112 patients with 325 different diagnoses. This represents a 24.3 percent increase in the number of patients served by PAF in 2010.
REAP's purpose is to communicate issues to Federal and State regulatory bodies, Congress, health care insurers and others that regulate/develop/manage and/or impact health delivery, coverage, cost and availability of services to the United States population.
National Patient Advocate Foundation is a national non-profit organization providing the patient voice in improving access to, and reimbursement for, high-quality healthcare through regulatory and legislative reform at the state and federal levels. NPAF translates the experience of millions of patients who have been helped by our companion, Patient Advocate Foundation, which provides professional case management services to individuals facing barriers to healthcare access for chronic and disabling disease, medical debt crisis and employment-related issues at no cost.
*Established by NPAF in 2010
SOURCE National Patient Advocate Foundation