Posts Tagged ‘FDA regulations’

Court approves Vascepa® for off-label use despite pushback from FDA

pill_bottlesOn Friday August 7th, the Southern District Court of New York permitted Amarin Pharma to promote certain off-label uses of its 2012 FDA-approved drug, Vascepa®. The FDA has made it known that promoting uses of drugs that are not on FDA-approved labeling violates the Food, Drug, and Cosmetic Act (FDCA). This means that a manufacturer can promote its drug for its approved intended use, but a true and non-misleading promotion of an off-label use is considered misbranding. Doing so is prohibited conduct, and could result in penalties and criminal prosecution. Read more…

The inherent risk surrounding nutraceuticals

May 20, 2015 Leave a comment

pills2Nutraceuticals, a $30 billion industry in the United States, come in the form of capsules, bars, drinks, lotions, pills, and powders. The medical and therapeutic benefits they claim to offer vary from renewed sexual drive, to enhanced athletic performance, to fewer wrinkles. Many are nutritional supplements which, according to JAMA Internal Medicine, were taken by 45 percent of people to “improve” and 33 percent of people to “maintain” overall health. However, only 23 percent of products were recommended by a healthcare provider.

When taking dietary supplements, bear in mind that they are not required to be tested or registered with the United States Food and Drug Administration (FDA). The FDA’s job in oversight is primarily registering facilities, confirming those facilities are operating within proper manufacturing practices, and investigating products after they hit the shelves. Nutraceutical companies may assert that their product has been Read more…

FDA suggests social media standards for pharma and med device companies

fda_twitterThe FDA issued a pair of guidelines on Tuesday for pharmaceutical and medical device companies regarding the use of social media and internet communication for medical products. While other industries, including financial services , retail and real estate have immersed themselves in using social media as a marketing tool,  pharmaceutical companies have been slower to embrace the trend, due to strict regulatory and privacy laws. But as technology continues to drive consumer and patient behavior – a 2013 study found that one in four interactions with doctors, healthcare professionals and patients in the U.S. is digital – the FDA recognizes a need to adapt to these changes and in turn, establish industry best practices for social media use. The long-awaited guidance aims to provide consumers with more accurate, accessible information online, and proposes guidelines for pharmaceutical and medical device companies about how to correct misinformation posted online by others. Read more…

New trial regulations for medical device makers in South Korea

February 6, 2014 Leave a comment

sKoreaThe Ministry of Food and Drug Safety  (MFDS) will implement new clinical trial regulations for certain high risk medical devices looking to obtain trial approval. The agency announced last October that beginning in 2014, 68 devices (those that are either transplanted or absorbed into the human body) must submit trial data as part of technical documentation before receiving approval to conduct trials.

The MFDS, formally known as the Korea Food and Drug Administration, is a South Korean government agency that oversees the safety and efficiency of foods, pharmaceuticals, medical devices and cosmetics and supports the development of the food and pharma industries. Read more…

FDA proposal could give generic drug makers independent labeling rights

November 18, 2013 Leave a comment

genericEarlier this month the FDA proposed a new rule that would grant generic drug manufacturers permission to update product labels independently with new safety information, without having to wait until the brand-name counterpart drug makes similar changes. The ruling would permit generic makers to submit a “changes being effected”(CBE) supplement to the FDA; the agency could either accept the changes or reject them at a later time. The proposal comes on the heels of several U.S. Supreme Court rulings that limited the liability of generic manufacturers. Those previous decisions, which required generic labels to match brand name products, protected generic makers from failure-to-warn suits since they had little control over what safety information was provided to patients.

Supporters say the proposal encourages generic manufacturers to participate more directly with the FDA to ensure that patients and health care providers receive the latest safety information on Read more…

FDA’s new cyber security lab tests for “fuzzing” to promote medical device safety

August 26, 2013 Leave a comment

pacemakerThe FDA will reportedly launch a new cyber security laboratory to address security concerns for medical devices. The administration says that it is in the midst of developing new product regulations for medical device manufacturers to guard against hacking attempts. The labs will be used to test medical devices for vulnerabilities to data “bugs” that cause software to crash and disable system functions. The process, called “fuzzing” subjects a piece of software in the device to an influx of unintended input data requests in order to test how the device responds. The results help determine any vulnerabilities and allow manufacturers to fix them before the product is released, thus making products safer for patients and less likely to break down.

The announcement comes in response to several warnings from the National Institute of Standards and Technology (NIST), security researchers and other government agencies about the need Read more…

Activists pressure FDA for more generic drug regulation

genericdrugsLast month the U.S. Supreme Court set aside a 21 million jury verdict for a woman who was injured as a result of an adverse reaction to a generic drug, similar to common pain medication like ibuprofen. In Mutual Pharmaceutical Co. Inc. v. Bartlett, the court ruled that the consumer’s design defect claim against the company was pre-empted, since generic drugs must be designed the same way as their brand-name counterparts. The decision, the latest in a string of drug-regulatory cases helps to shield generic drug makers from personal injury litigation claims and signals another victory for the industry.

Two years ago, the court ruled in Pilva Inc. v. Mensing that generic drug manufacturers could not be held liable for failure to warn claims. In response, several Democratic Read more…