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  • FDA Expresses Interest in Comparative Price of Drugs (But not in the way you Think)

    Watch a drug advertisement in the US-any one, really-and one thing you're unlikely to hear any mention of is the drug's cost. That's not always an accident, as the myriad of insurance companies, co-pays, state insurance programs, private assistance programs, coupons and other incentives mean that the true cost of a drug is rarely seen by consumers and is rarely the same for two people. But assume, for a moment, that such an instance existed-that a drug ("Drug A") cost ...
  • FDA's Proposal to Cut Down on Risks Listed in Drug Ads Wins Praise From Drug Companies

    In February 2014, the US Food and Drug Administration (FDA) announced that it wanted to revisit how it regulates the "major statement" of its drug advertisements, calling them potentially too long, leaving consumers more confused than informed. Now the pharmaceutical industry is weighing in on FDA's call for comments, supporting both its call for additional research and its goal of easing current requirements. Background At present, companies are required to present th...
  • Feature ArticlesFeature Articles

    Trends in Personalized Medicine

    As decades of experience have shown, drugs can work very differently in different individuals. Advances in genetic sequencing and genomics made early in the last decade sparked the hope that identifying certain genetic characteristics or biomarkers would yield significant advances in healthcare and give rise to a new era of personalized medicine or, as it is often defined, the practice of administering "the right drug, at the right time, at the right dose, for the right p...
  • FDA Seeks to Determine how Consumers Find Health Information Online, Perceive Benefit-Risk

    Direct-to-consumer marketing is a topic of regular interest to regulators with the US Food and Drug Administration. At various times during the past several years, it has announced studies involving the use of composite scores in DTC advertising, the affect of DTC advertising on healthcare professionals , and corrective advertising resulting from improper DTC marketing. Now it's making some substantial changes to a DTC study first approved in 2011, according to docu...
  • Citizen Petition Claims Lab-Developed Tests aren't Devices and are Beyond FDA Regulation

    US Food and Drug Administration (FDA) Commissioner Margaret Hamburg recently announced that her agency would soon end a long-standing policy of enforcement discretion toward a classification of diagnostic devices known as laboratory-developed tests (LDTS), but now at least one association has filed a Citizen Petition with the agency seeking to exempt LDTs from new guidance, new regulation or seemingly any regulation whatsoever. Background Under normal circumstances, med...
  • Opening the Black Box: FDA Plans Study of DTC Advertising and Use of Composite Scores

    The US Food and Drug Administration (FDA) has announced that it plans to move forward with a proposed study on direct-to-consumer (DTC) advertising first announced in August 2012 regarding the use of composite scores in advertising and whether consumers have sufficient understanding to allow for their use. Background Composite scores are essentially a collection of clinical endpoints combined into a single overall score. For example, an allergy drug might use a comp...
  • FDA Gets Go-Ahead for Study of DTC Advertising and Social Media

    The US Food and Drug Administration (FDA) will move forward with a survey of healthcare professionals regarding their opinions and perceptions about prescription drug promotion after receiving approval from the Office of Management and Budget (OMB), the executive branch's regulatory clearing house. Background FDA's intent to conduct the survey was first announced in January 2012, when it said in a Federal Register posting that it was soliciting comments on a propo...
  • Regulators to Study use of Composite Scores in Drug Advertising

    Regulators at the US Food and Drug Administration (FDA) are planning to conduct a study on consumers' understanding of composite endpoint scores used in direct-to-consumer (DTC) advertising. Composite scores are essentially a collection of clinical endpoints combined into a single overall score. An allergy drug might, explains FDA, use a composite score that measures a patient's runny nose, congestion, nasal itchiness and sneezing. Do Consumers Understand What a Compo...
  • US Regulators Move Ahead With Planned Study on DTC Marketing

    How long does it take for the US Food and Drug Administration (FDA) to get a study up and running? For at least one previously-proposed study on promotional advertising, nearly two years. Since September 2010, FDA has been looking to conduct a study on consumers to assess the effects of promotional offers in direct-to-consumer prescription drug print advertising. In its 22 September 2010 Federal Register posting , FDA proposed the study as a way to look at how coupons...
  • Report: India Moving to Regulate Biotechnology Research

    The Indian government is preparing to establish a new regulatory agency in charge of regulating biotechnology product research, transport, import, manufacture and use, reports The Economic Times . The new authority, tentatively known as the Biotechnology Regulatory Authority of India (BRAI), would be established under a new draft bill before the Indian parliament. The agency, in addition to its other duties, would also be in charge of formulating a risk assessment a...
  • PhRMA: Pre-Submission Advertising Guidance Violates Free Speech Rights

    The Pharmaceutical Research and Manufacturers of America (PhRMA) is calling for program proposed by the US Food and Drug Administration (FDA) to be scaled back, saying the agency's proposal to review all advertising before it can be disseminated is overly burdensome and violates its commercial rights to free speech. FDA proposed on 12 March to change how it reviews TV advertisements-see Regulatory Focus' 12 March story, " New FDA Draft Guidance on DTC Television Advert...
  • FDA Reopens Comment Period on DTC Advertising Regulations

    The US Food and Drug Administration (FDA) announced this week it is reopening a comment period on a proposed rule on presenting major statements in director-to-consumer (DTC) advertisements, extending comments for an additional 15 days. The 23 March Federal Register notice follows an initial posting on 27 January, entitled Experimental Evaluation of the Impact of Distraction on Consumer Understanding of Risk and Benefit Information in Direct-to-Consumer Prescriptio...