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

On Friday August 7^th, 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.

The inherent risk surrounding nutraceuticals

Nutraceuticals, 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

FDA suggests social media standards for pharma and med device companies

The 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.

New trial regulations for medical device makers in South Korea

The 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.

FDA proposal could give generic drug makers independent labeling rights

Earlier 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

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

The 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

Activists pressure FDA for more generic drug regulation

Last 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

FDA asks medical device developers for feedback on new draft guidance

“Recall” or “product enhancement” – the distinction between the two terms can be tricky, especially for medical device manufacturers aiming to comply with current industry codes and regulations. In the case of a recall, developers face serious financial and reputational damage; product enhancements, on the other hand, rarely cause bad publicity and tend to only involve improvements made to a product.

The U.S. Food and Drug Administration (FDA) recently issued draft guidance to help clarify when a change to a product constitutes a recall or a product enhancement, and the difference between the two. The FDA has asked companies to review the draft guidance and submit feedback by May 23, 2013.

New FDA ruling on manufacturing requirements could lead to more warnings

The FDA issued a final ruling last month on Current Good Manufacturing Practice (CGMP) requirements for products that combine devices, drugs and/or biologics. The ruling will go into effect July 27, 2013, and clarifies CGMP requirements for products that are a mixture of any of these products as packaged together or as a single-entity combination. While in the past, the guidelines for some combination products (such as those that are manufactured and marketed separately) were fairly straightforward, the rules for “single-entity” and co-packaged combination products had been less clear.

While it is mandatory for all pharmaceutical companies to comply with CGMP regulations, they are not meant to be prescriptive instructions, since the regulations apply to so many types of drugs and devices. Instead, the rules are meant to offer a general framework which all

Death toll prompts push for tighter federal regulations for compounding pharmacies

The recent meningitis outbreak linked to contaminated injections has led to many complaints about Food and Drug Administration (FDA) regulation and oversight of the compound pharmaceutical industry. Congress has pushed for more authority over this industry since the 1990s, but despite attempts to strengthen regulations, the industry has been successful in getting most of those efforts thrown out by the U.S. Supreme Court. It has left contradictory court rulings and uncertainty about how much power the FDA has to regulate compound pharmacists. Reports say that the compounding industry in is a $3 billion business with 7,500 pharmacies.

Sales representatives from the New England Compounding Center in Framingham MA, the pharmacy responsible for distributing the steroid shots that lead to the outbreak, reportedly undercut