• Prominent Consumer Group Petitions FDA for Changes to Device Approval System

    A prominent consumer advocacy group is once again calling for the US Food and Drug Administration (FDA) to make changes to the way it regulates medical devices, saying that the high-profile failure of one implantable medical device is evidence that all others should be classified as high-risk products and held to more stringent testing standards. Background Metal-on-metal hip implants were cleared in recent years through FDA's 510(k) pathway, which allows for companies ...
  • Brazilian Consumers Allowed to Purchase OTC Drug Products Under New Rules

    Brazilian consumers will not be able to purchase over-the-counter drug products at pharmacies according to new rules published 17 July 2012 by Brazilian health regulator Anvisa. Under the new rules, the OTC products may be purchased in a manner similar to cosmetics and dietary supplements,regulators explained. OTC drugs must be organized on pharmacy shelves by active ingredient with the cautionary statement that drugs may cause unwanted side effects.  Anvisa open...
  • 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...
  • Poll: Public In Favor of Increased Medical Device Regulation

    A poll commissioned by industry watchdog group Consumer Reports indicates the vast majority of consumers are in favor of a risk-averse regulatory framework for medical devices , giving ammunition to the group at a time when it is seeking to influence the debate over the reauthorization of the Medical Device User Fee Act . Consumers Union has taken the position that medical devices-particularly those cleared through the US Food and Drug Administration's (FDA) 510(k) pat...
  • Consumers Groups Attack FDA Over De Novo Process

    A group of 12 consumer groups is chastising the US Food and Drug Administration (FDA) for approving what they perceive to be 'high-risk' medical devices through FDA's de novo approval pathway . In a letter to FDA Commissioner Margaret Hamburg sent 29 February, the groups, including Consumers Union and Public Citizen, said that FDA's use of the de novo pathway was setting a bad precedent. "Medical devices intended to save lives should require FDA's most rigorous saf...
  • US Consumers Press For Experimental Drug Coverage

    A recent study published by the Harvard School of Public Health indicates that US consumers are largely in favor of government and private insurance plans covering treatment regimens determined to be experimental. 62% of study participants indicated that they "oppose decisions by the government or health insurance plans" to deny enrollees reimbursement for experimental or cost-ineffective treatments. Many government programs and private insurers will not provide reimbur...
  • Consumers Union Gears Up To Go After 510(k) Program, Urges MDUFA Markup

    Consumers Union, best known for their Consumer Reports publication, is launching a campaign to persuade Congress to force manufacturers using the 510(k) medical device regulation pathway to subject their products to the same premarket safety and efficacy tests that are required of pharmaceutical products. The 510(k) pathway is used by medical device manufacturers, and requires that manufacturers notify the US Food and Drug Administration (FDA) that they plan to market ...