FDA Strengthens Efforts Against Unapproved Drug Products
The U.S. Food and Drug Administration (FDA) has issued a final guidance document outlining its approach to medicines marketed without FDA approval. In the “Marketed Unapproved Drugs—Compliance Policy Guide,” the FDA encourages companies to comply with the drug approval process and states its primary concern as being unapproved products that may endanger public health. Priority will continue to be given to enforcement actions involving unapproved drugs that have potential safety risks, that lack evidence for their effectiveness, and that constitute health fraud. The guidelines also address the FDA’s plan for dealing with situations in which a company receives FDA approval for a drug that other companies have been selling unapproved. Consumers assume that widely marketed drugs have received FDA approval, the FDA said, and health care providers may prescribe unapproved drugs unknowingly. Many unapproved drugs affected by the guidance were developed and marketed before changes to the approval process. However, the FDA estimates that less than 2 percent of prescribed drugs are unapproved. Activity under the new guidelines will begin with prescription products that contain carbinoxamine, which has not been studied in young children and has not been approved for the treatment of cough and cold symptoms. For more information, visit http://www.fda.gov/cder/drug/unapproved_drugs/default.htm.
Colorado Governor Vetoes Bill for Health Contract Transparency
Colorado Governor Bill Owens vetoed bill S.B. 198, which was intended to ensure transparency in contracts between family physicians and health insurance companies in Colorado. The bill would have required health plans’ contracts with physicians to disclose compensation fee schedules, to end use of additional modifying documents without written agreement from physicians 30 days before the modification was implemented, and to describe the system and deadline for resolving disputes. It was supported by the Colorado Academy of Family Physicians (CAFP), as well as 85 out of 100 Colorado state legislators, according to Raquel Alexander, C.A.E., the executive vice president of the CAFP. However, Governor Owens felt the bill would create an unnecessary governmental intrusion into private-party contracts. The bill has been seen as a possible model for legislation in other states, and the American Academy of Family Physicians’ state government relations staff will examine its replicability. Physicians in Texas have worked for three years towards similar legislation. For more information, visit https://www.aafp.org/online/en/home/publications/news/news-now/government-medicine/20060531contractsbillveto.html.
NIA Offers Easy-to-Read Booklets on Alzheimer’s and Memory Loss
The National Institute on Aging (NIA) is offering two free booklets designed to help those with limited literary skills learn about Alzheimer’s disease and memory loss. The books are written in plain language with stories, photographs, and other aids to comprehension. “Understanding Memory Loss” informs readers of the differences between mild forgetfulness and serious memory problems, explains the causes of memory problems and their treatments, discusses what those worried about memory loss should do, and suggests ways in which family members can help. “Understanding Alzheimer’s Disease” includes information on signs and treatment of the disease, the importance of seeing a physician early, and help for caregivers. The booklets were produced to provide clear, accessible information about Alzheimer’s disease and memory loss to all who need it, and feedback was sought through local field testing and a series of interviews. For more information, visit http//:www.alzheimers.nia.nih.gov, or call 800–438–4380.
HHS Posts Information on Medicare Hospital Admissions Payments
The Department of Health and Human Services (HHS) posted information on Medicare payments for 30 elective procedures and other hospital admissions through the Centers for Medicare and Medicaid Services (CMS) Web site at http://www.cms.hhs.gov/HealthCareCon-Init/01_Overview.asp#TopOfPage. The information includes the payment range by county and the number of patients at each hospital to receive various treatments provided to older persons and those with disabilities in fiscal year 2005. The HHS hopes that posting the data will help consumers, providers, and payers make more-informed health care decisions. Public availability of the data, part of efforts to make health care more affordable and accessible, was directed by President Bush. The CMS also will post information on common elective procedures for ambulatory surgery centers this summer and information on hospital outpatient and physician services in the fall. To learn more, visit http://www.hhs.gov/news/press/2006pres/20060601a.html.
SAMHSA Issues Alert About Potentially Lethal Drug Combination
Following reports of deaths after use of fentanyl with heroin or cocaine, the Substance Abuse and Mental Health Services Administration (SAMHSA) issued an action alert warning substance abuse professionals and others of the potentially lethal combination. Fentanyl, a narcotic analgesic 50 to 100 times more powerful than morphine, can cause irregular heart beat, inability to breathe, and death. The addition of fentanyl to heroin and cocaine sold on the streets is thought to have caused 33 deaths in Detroit (Mich.) in May and more than 100 deaths in Philadelphia/Camden (Pa.), Chicago (Ill.), St. Louis (Mo.), and Detroit since September. Buyers may not be aware that they are purchasing the combination, and the alert emphasizes the importance of educating users about the possible danger. It also encourages recipients to share information with emergency room personnel and local health care providers, and encloses a fact sheet about preventing, detecting, and treating overdoses. For more information, visit http://www.samhsa.gov/news/newsreleases/060806drugcombo.htm.
NIH Awards Almost $4 Million for “Bench to Bedside” Research Projects
The National Institutes of Health (NIH) awarded nearly $4 million to fund 19 research projects under its “bench to bedside” research program. The program was created to encourage collaboration among scientists working in laboratories and clinical investigators working with patients, and funds projects designed to speed the evolution of laboratory discoveries into medical treatments. Awards for 2006 were made in five categories: rare diseases, acquired immunodeficiency syndrome research, minority health, women’s health, and a fifth category cofunded by sponsoring institutes. This year is the first in which minority health and women’s health projects have been funded specifically. Selection criteria included quality of science, promise for becoming an active clinical trial, and potential for offering a new treatment or understanding of a disease process. For more information, visit http://www.nih.gov/news/pr/jun2006/cc-07.htm.
HHS Approves Medicaid Reform in Idaho, Prenatal Care in Texas
Medicaid reform in Idaho that introduces targeted benefits based on age and health status has been approved by the HHS. Idaho will offer benefit packages aimed at children, persons with disabilities, and beneficiaries eligible for Medicaid and Medicare. All packages are voluntary, and those who choose them can return to standard Medicaid at any time. Idaho is the third state to take advantage of the Deficit Reduction Act passed in 2005, which allows states more options for Medicaid design. Changes to Medicaid programs in West Virginia and Kentucky were approved in May. The HHS also approved the expansion of Texas’ state children’s health insurance program to cover prenatal care for women with a family income up to twice the federal poverty level. Texas is the ninth state to adopt this policy, allowed under a 2003 regulation. For more information, visit http://www.hhs.gov/news/press/2006pres/20060525.html and http://www.hhs.gov/news/press/2006pres/20060602.html.