Download or read book Prescription Drugs Improvements Needed in FDA s Oversight of Direct to Consumer Advertising written by and published by DIANE Publishing. This book was released on with total page 52 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Prescription Drugs written by United States Government Accountability Office and published by Createspace Independent Publishing Platform. This book was released on 2017-09-13 with total page 52 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Prescription Drugs written by United States Government Accountability Office and published by Createspace Independent Publishing Platform. This book was released on 2018-05-17 with total page 34 pages. Available in PDF, EPUB and Kindle. Book excerpt: Prescription Drugs: Trends in FDA's Oversight of Direct-to-Consumer Advertising
Download or read book Prescription Drugs Improvements Needed in FDA s Oversight of Direct to Consumer Advertising written by and published by . This book was released on 2006 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Gao 07 54 Prescription Drugs written by United States Government Accountability Office and published by Createspace Independent Publishing Platform. This book was released on 2018-01-29 with total page 52 pages. Available in PDF, EPUB and Kindle. Book excerpt: GAO-07-54 Prescription Drugs: Improvements Needed in FDA's Oversight of Direct-to-Consumer Advertising
Download or read book Prescription Drugs Trends in FDA s Oversight of Direct to Consumer Advertising written by Marcia Crosse and published by DIANE Publishing. This book was released on 2008-10 with total page 19 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Prescription Drug Advertising to Consumers written by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations and published by . This book was released on 1984 with total page 276 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Prescription drugs written by Marcia Crosse and published by . This book was released on 2008 with total page 15 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Prescription Drugs written by United States. General Accounting Office and published by . This book was released on 2002 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book GAO written by and published by . This book was released on 2003 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book The Future of Drug Safety written by Institute of Medicine and published by National Academies Press. This book was released on 2007-02-27 with total page 346 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Direct to consumer Advertising of Prescription Drugs written by United States. Congress. Senate. Special Committee on Aging and published by . This book was released on 2003 with total page 152 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Direct to consumer Advertising written by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations and published by . This book was released on 2008 with total page 556 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Reducing Race Differences in Direct to Consumer Pharmaceutical Advertising written by Stephany De Scisciolo and published by Rowman & Littlefield. This book was released on 2018-08-31 with total page 141 pages. Available in PDF, EPUB and Kindle. Book excerpt: Reducing health disparities by increasing access to health information is a national health policy priority. Evidence exists that direct-to-consumer pharmaceutical advertising (DTCA) is effective in educating consumers about health issues. However, racial disparities exist in such advertising. In 2009, the Food and Drug Administration (FDA) issued a report that included recommendations for enhancing the ability of DTCA to reach disadvantaged populations, including racial and ethnic minorities. Reducing Race Differences in Direct to Consumer Pharmaceutical Advertising compares the pharmaceutical advertisements placed in five popular women’s magazines published prior to and following the 2009 FDA report to assess the impact of these recommendations on the content and appearance of advertisements placed in magazines of differing racial orientation. From a health policy perspective, the results are disappointing. The FDA recommendations had no impact on the frequency or content of the DTCA appearing in White-oriented versus Black-oriented magazines. In fact, far fewer drugs used to treat life-threatening conditions were advertised in Black-oriented magazines after the 2009 FDA recommendations. The book concludes that enhancing the educational and motivational value of DTCA will require more than a set of recommendations. The results shed light on the pharmaceutical industry’s compliance with both hard and soft regulation. Neither federal recommendations nor industry guidelines resulted in the changes to DTCA envisioned by the FDA. Regulatory action is necessary to ensure that pharmaceutical companies develop advertising campaigns that not only promote their products, but also positively impact the health outcomes of those who read their ads.
Download or read book The Salience of Marketing Stimuli written by Gianluigi Guido and published by Springer Science & Business Media. This book was released on 2001-04-30 with total page 324 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book presents a theoretical approach for enhancing consumer processing and memory of marketing communication.
Download or read book Medical Devices and the Public s Health written by Institute of Medicine and published by National Academies Press. This book was released on 2011-10-25 with total page 318 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.
Download or read book FDA in the Twenty First Century written by Holly Fernandez Lynch and published by Columbia University Press. This book was released on 2015-09-08 with total page 499 pages. Available in PDF, EPUB and Kindle. Book excerpt: In its decades-long effort to assure the safety, efficacy, and security of medicines and other products, the Food and Drug Administration has struggled with issues of funding, proper associations with industry, and the balance between consumer choice and consumer protection. Today, these challenges are compounded by the pressures of globalization, the introduction of novel technologies, and fast-evolving threats to public health. With essays by leading scholars and government and private-industry experts, FDA in the Twenty-First Century addresses perennial and new problems and the improvements the agency can make to better serve the public good. The collection features essays on effective regulation in an era of globalization, consumer empowerment, and comparative effectiveness, as well as questions of data transparency, conflicts of interest, industry responsibility, and innovation policy, all with an emphasis on pharmaceuticals. The book also intervenes in the debate over off-label drug marketing and the proper role of the FDA before and after a drug goes on the market. Dealing honestly and thoroughly with the FDA's successes and failures, these essays rethink the structure, function, and future of the agency and the effect policy innovations may have on regulatory institutions abroad.
