Trends In Direct To Consumer Advertising Of Prescription Drugs
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Prescription Drugs: Trends in FDA's Oversight of Direct-to-Consumer Advertising
Author | : Marcia Crosse |
Publisher | : DIANE Publishing |
Total Pages | : 19 |
Release | : 2008-10 |
Genre | : Business & Economics |
ISBN | : 1437905714 |
The FDA is responsible for overseeing direct-to-consumer (DTC) advertising (ad) of prescription drugs, which includes TV, magazines, and the Internet. If FDA identifies a violation of laws or reg¿s. in a DTC ad material, the agency may issue a regulatory letter (RL) asking the drug co. to take specific actions. In 2002, there were delays in FDA¿s issuance of these RL. This testimony discusses trends in FDA¿s oversight of DTC ad and the actions FDA has taken when it identifies violations. This statement discusses the: (1) DTC ad materials FDA reviews; (2) FDA¿s process for issuing RL citing DTC ad materials and the number of RL issued; and (3) the effectiveness of FDA¿s RL at limiting the dissemination of false or misleading DTC ad. Charts and tables.
Prescription Drugs
Author | : United States Accounting Office (GAO) |
Publisher | : Createspace Independent Publishing Platform |
Total Pages | : 34 |
Release | : 2018-05-21 |
Genre | : |
ISBN | : 9781719425544 |
Prescription Drugs: Trends in FDA's Oversight of Direct-to-Consumer Advertising
The Future of Drug Safety
Author | : Institute of Medicine |
Publisher | : National Academies Press |
Total Pages | : 346 |
Release | : 2007-02-27 |
Genre | : Medical |
ISBN | : 0309133947 |
In the wake of publicity and congressional attention to drug safety issues, the Food and Drug Administration (FDA) requested the Institute of Medicine assess the drug safety system. The committee reported that a lack of clear regulatory authority, chronic underfunding, organizational problems, and a scarcity of post-approval data about drugs' risks and benefits have hampered the FDA's ability to evaluate and address the safety of prescription drugs after they have reached the market. Noting that resources and therefore efforts to monitor medications' riskâ€"benefit profiles taper off after approval, The Future of Drug Safety offers a broad set of recommendations to ensure that consideration of safety extends from before product approval through the entire time the product is marketed and used.
Prescription Drugs
Author | : United States. General Accounting Office |
Publisher | : |
Total Pages | : 24 |
Release | : 1991 |
Genre | : Advertising |
ISBN | : |
Prescription Drugs
Author | : United States. General Accounting Office |
Publisher | : |
Total Pages | : 40 |
Release | : 1991 |
Genre | : Advertising |
ISBN | : |
Prescription Drugs
Author | : United States Government Accountability Office |
Publisher | : Createspace Independent Publishing Platform |
Total Pages | : 52 |
Release | : 2017-09-13 |
Genre | : |
ISBN | : 9781976365126 |
The Food and Drug Administration (FDA) is responsible for overseeing direct-to-consumer (DTC) advertising of prescription drugs. If FDA identifies a violation of laws or regulations in a DTC advertising material, the agency may issue a regulatory letter asking the drug company to take specific actions. GAO was asked to discuss (1) trends in drug company spending on DTC advertising and other activities; (2) what is known about the relationship between DTC advertising and drug spending and utilization; (3) the DTC advertising materials FDA reviews; (4) the number of regulatory letters that cited DTC materials and FDA's process for issuing those letters; and (5) the effectiveness of these letters at limiting the dissemination of violative DTC advertising. GAO reviewed research literature, analyzed FDA's processes, and examined FDA documentation.
Making Medicines Affordable
Author | : National Academies of Sciences, Engineering, and Medicine |
Publisher | : National Academies Press |
Total Pages | : 235 |
Release | : 2018-03-01 |
Genre | : Medical |
ISBN | : 0309468086 |
Thanks to remarkable advances in modern health care attributable to science, engineering, and medicine, it is now possible to cure or manage illnesses that were long deemed untreatable. At the same time, however, the United States is facing the vexing challenge of a seemingly uncontrolled rise in the cost of health care. Total medical expenditures are rapidly approaching 20 percent of the gross domestic product and are crowding out other priorities of national importance. The use of increasingly expensive prescription drugs is a significant part of this problem, making the cost of biopharmaceuticals a serious national concern with broad political implications. Especially with the highly visible and very large price increases for prescription drugs that have occurred in recent years, finding a way to make prescription medicinesâ€"and health care at largeâ€"more affordable for everyone has become a socioeconomic imperative. Affordability is a complex function of factors, including not just the prices of the drugs themselves, but also the details of an individual's insurance coverage and the number of medical conditions that an individual or family confronts. Therefore, any solution to the affordability issue will require considering all of these factors together. The current high and increasing costs of prescription drugsâ€"coupled with the broader trends in overall health care costsâ€"is unsustainable to society as a whole. Making Medicines Affordable examines patient access to affordable and effective therapies, with emphasis on drug pricing, inflation in the cost of drugs, and insurance design. This report explores structural and policy factors influencing drug pricing, drug access programs, the emerging role of comparative effectiveness assessments in payment policies, changing finances of medical practice with regard to drug costs and reimbursement, and measures to prevent drug shortages and foster continued innovation in drug development. It makes recommendations for policy actions that could address drug price trends, improve patient access to affordable and effective treatments, and encourage innovations that address significant needs in health care.
Ethical Criteria for Medicinal Drug Promotion
Author | : World Health Organization |
Publisher | : |
Total Pages | : 32 |
Release | : 1988 |
Genre | : Business & Economics |
ISBN | : |
"Resolution WHA41.17 adopted by the Forty-first World Health Assembly, 13 May 1988" -- p.1.