Showing all posts written by Alison Hill

The Food and Drug Administration has issued a notice announcing a public hearing on November 9 & 10, 2016 to gather input relating to companies’ communications about their medical products, with a particular focus on communications regarding off-label uses of approved drugs and medical devices.

Currently, the FDA regulates how pharmaceutical and medical device companies can communicate uses of their products through approved labels, but many of those companies believe that greater sharing of information could significantly enhance patient treatments and outcomes.  The press release explains that the FDA is aware of technological and business changes that are increasingly affecting medical decision making and prescribing.  Such awareness prompted the FDA to review its regulations and policies governing companies’ communications regarding unapproved uses of approved medical products.  The Agency anticipates that feedback from the meeting will help inform policy development in this area.

In the press release, specific attention is drawn to the FDA’s heightened interested in comprehensively understanding: how increased communications from companies regarding unapproved uses could impact the public health; how changes in the health care system that give payers and formulary committees more power in prescribing practices incentivize firms to provide more safety and effectiveness data; the impact of increased accessibility of information relating to medical products on companies’ incentives to communicate information about off-label uses; the standards that should apply to off-label communications to minimize the potential of harm; and what factors should be considered when evaluating whether communications regarding unapproved uses are misleading, including what information must be disclosed to ensure consumers are not misled.

In August, 2016, the Pharmaceutical Research and Manufacturers of America (PhRMA) and Biotechnology Innovation Organization (BIO) released guidelines intended to improve communication between biopharmaceutical companies and other health care professionals.  Following the FDA’s announcement of the November meeting, Jeff Francer, Vice President and Senior Counsel of PhRMA, issued a statement praising the FDA on its efforts to modernize its regulations surrounding information sharing:

Given our increasingly data-driven, value-based health care system, we hope that FDA will act quickly to define new and clearer regulatory standards to permit responsible sharing of information and data about medicines with other parties in the health care system.

Comments will be accepted after the hearing, until January 9, 2017.

The U.S. Food and Drug Administration has announced a proposal to ban most powdered medical gloves in the United States due to a health risk posed to patients.

Powder is often added to medical gloves in an effort to make them easier to put on and take off, but aerosolized glove powder on latex gloves can cause serious respiratory allergic reactions. Additionally, powdered synthetic gloves, although not associated with an increased risk of allergic reactions, pose several potential medical complications, including wound inflammation, airway inflammation, and post-surgical adhesions.

According to Jeffrey Shuren, M.D., director of FDA’s Center for Devices and Radiological Health:

“This ban is about protecting patients and health care professionals from a danger they might not even be aware of. We take bans very seriously and only take this action when we feel it’s necessary to protect the public health.”

If approved, the ban will apply to powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for surgeon glove lubrication. The ban would not apply to powdered radiographic protection gloves, because the agency is not aware of any such gloves available on the market. Non-powdered surgeon gloves and non-powdered patient examination gloves would also be excluded from the ban.

Prior to the ban proposal, the FDA conducted a thorough review of scientific literature and comments received in response to a February 2011 public inquiry on the topic. The FDA also determined that the ban would be unlikely to impact medical practice due to the wide availability of similar, non-powdered gloves.

The proposed rule is available online for public comment for 90 days.

Zyga Technology, Inc., a medical device company dedicated to the research, development, and commercialization of surgical solutions to treat conditions of the lumbar spine, recently announced that it has received 510(k) clearance from the U.S. Food and Drug Administration to market its SImmetry® Sacroiliac Joint Fusion System using either a two-incision or a single-incision technique. The SImmetry System uses a minimally invasive surgery procedure and is designed to stabilize the sacroiliac joint.

David Greenwald, M.D. of the Flagler Brain and Spine Institute in St. Augustine, stated:

In the operating room, surgeons need as many options as possible to effectively treat each individual. . . .  This new SImmetry technique allows me to offer patients a single, one-inch incision and to adapt the surgery to their individual anatomy and condition.

The Centers for Disease Control and Prevention lists low back pain as the second most common cause of disability of adults in the U.S.  Accordingly, the Centers for Medicare and Medicaid Services assigned a Category 1 CPT code to minimally invasive sacroiliac joint fusion, improving patient access to the procedure.

St. Jude Medical, Inc., a global medical device manufacturer, announced that it has received FDA approval of the company’s Protégé MRI™ spinal cord stimulation (SCS) system, along with approval for related percutaneous leads, which have received MR-conditional labeling for use with the Protégé MRI system for chronic pain treatment. According to the press release, the Protégé MRI system is the world’s smallest available MR-conditional SCS implantable pulse generator, as well as the only device to allow patients to safely undergo head and extremity MRI scans. Additionally, the press release states that it is the only device to offer software upgrades as an alternative to surgical device replacement.

“With the approval of the Protégé MRI system, St. Jude Medical has helped remove a barrier for some patients who may benefit from SCS therapy, while preserving the ability of those patients to access future technology and therapy advancements wirelessly through upgradeable technology,” said Dr. Eric Fain, group president of St. Jude Medical.

The press release notes that SCS therapy can offer proven chronic pain relief for many patients while reducing or even eliminating the use of pain medication. According to the press release, spinal cord stimulation therapy utilizes a small implanted generator to deliver electrical impulses to the nerve fibers of the spinal column via thin wires, or leads, with electrodes; the electrical pulses reduce the sensation of pain by masking or interrupting pain signals travelling up the spinal cord to the brain.

St. Jude Medical has also stated that it plans to seek updated labeling for several existing products, including the Penta™ paddle lead, to enable more patients to safely undergo MRI scans. The company also indicated that it plans to submit testing data supporting full-body MRI conditional scan labeling for future SCS systems.

Essential Medical, Inc., a privately held medical device company aiming to create and commercialize new vascular closure devices for femoral punctures after cardiac catheterization procedures, announced that it has successfully completed First in Man studies for its MANTA Large Bore Vascular Closure device, a device designed to seal 18F large bore femoral punctures.

According to the press release, the MANTA devices were deployed in less than one minute in each of five patients, achieving hemostasis at the large bore puncture site with exceptional clinical, angiographic and hemodynamic success in all patients. The press release also indicated that none of the patients showed evidence of hematoma, and all patients were discharged the next day.

Essential Medical stated that Dr. Gary Roubin, MD, PhD, a leading interventional cardiologist, performed the first two cases. Dr. Roubin remarked:

“In interventional cardiology it’s critical to define the problem that the patient is facing, solve the problem and use the best clinical science available to confirm beneficial outcomes. We’re doing that with MANTA and it promises to be a truly transformative technology for providing percutaneous access for large bore therapeutic devices.”

According to Essential Medical, MANTA seals femoral arterial punctures made during cardiac catheterization procedures such as transcatheter aortic valve replacement (TAVR), balloon aortic valvuloplasty (BAV), and the endovascular treatment of abdominal aortic aneurysms (AAA), employing sealing components similar to the Company’s other closure device, X-Seal, which received CE mark approval last month, and is said to be indicated for smaller punctures for angiography, angioplasty, and stenting.

Essential Medical indicates that large bore femoral access has been associated with bleeding complications, the need for transfusions, increased hospital costs, and patient discomfort and disability. Dr. Lawrence Garcia, Chief of International Cardiology at St. Elizabeth’s Medical Center in Boston, also participated in the study and stated that the device satisfies a “critical unmet need for endovascular procedures in being able to quickly and reliably close large bore catheter channels.”

Greg Walters, founder and CEO, states in the announcement that Essential Medical seeks to commence a CE-marketing study of the MANTA device in early 2015.