New Total Ankle Replacement Systems Earns FDA Approval

People who suffer from arthritic or deformed ankles resulting in a loss of range of motion in the joint now may have a new surgery option.

The Food and Drug Administration has just approved a first-of-its-kind total ankle replacement system made by Small Bone Innovations Inc. of Morrisville, Pa. The medical device, called the Scandinavian Total Ankle Replacement System, or STAR for short, uses bearings and a flexible plastic surface to replace a deformed or damaged ankle.

Arthritis and injuries can destroy the cartilage that cushions the ankle bone, allowing the joint to grind and cause severe pain. In some cases, a total ankle replacement may be necessary.

The STAR system is an alternative to traditional ankle-replacement procedures, in which the tibia (shin bone) is fused to the talus bone in the ankle to stabilize the joint. The surgery substantially reduces the ability of the foot to move up and down.

The STAR system can provide more rotation of the ankle and better movement of the ankle joint, officials said. It is designed to more closely imitate the natural movement of the ankle, according to an FDA official.

Other fixed-bearing ankle devices have already been approved by the FDA. Those devices use an articulating surface which is molded, locked, or attached to a metal component to stabilize the ankle.

A two-year clinical study of the STAR system found that it produced no more side effects, surgical interventions, or major complications compared to traditional ankle fusion surgery, the FDA said.

The maker of the STAR system will for the next eight years evaluate the safety and effectiveness of the device as part of the FDA approval.

Source: attorneyatlaw.com

FDA approves Power Medical Interventions instruments

The Food and Drug Administration granted marketing clearance Wednesday to a console-and-power unit for detachable surgical instruments developed by Power Medical Interventions Inc.

The Langhorne, Pa., medical-device company plans to begin selling the iDrive Intelligent Power unit and iConsole “effective immediately.”

The products, according to Power Medical (OTCBB:PMII), are designed to support a variety of minimally invasive procedures and offer surgeons “a broad range of cutting and stapling configurations combined with increased flexibility, access and precision.”

The iDrive is a hand-held, computer-controlled power unit to which any of the company’s Intelligent Surgical Instruments can be attached. The iConsole is a wireless device that communicates directly with the iDrive during surgical procedures to output specific auditory and visual reference information through a speaker and liquid crystal display

Source:Business Journal

FDA Issues Draft Guidance on Presenting Risk Information in Promotional Materials

The US Food and Drug Administration posted a draft guidance for industry, Presenting Risk Information in Prescription Drug and Medical Device Promotion, on its website May 26, that describes factors the agency considers when evaluating advertisements and promotional labeling for prescription drugs and medical devices. Although not stated, this draft guidance may have been pushed through as a result of the industry backlash from FDA’s issuance of 14 untitled letters for online advertising violations (see back story, FDA Issues 14 Untitled Letters for Online Ad Violations). The draft guidance applies to promotional materials for consumers and healthcare professionals as well as promotional materials in all media, including websites. The document also affects product benefit information that appears in promotional materials.

“FDA believes it is critically important to disclose risk information in prescription drug and medical device promotion appropriately and effectively to healthcare professionals and consumers,” states the draft guidance. “This information helps consumers know whether drugs or devices may be appropriate for them as well as what they should tell their healthcare professionals about before taking or using or while taking or using a product. It also lets consumers know what risks they might experience and what steps they need to take for safety reasons (e.g., no driving) because of taking or using a product.

Direct-to-consumer prescription drug advertising research has shown that 60%of patients believe ads directed at them do not provide enough information about risks, according to the dfaft guidance. In addition, 60% of physicians believe that “patients have little or no understanding from these ads about what the possible risks and negative effects of the products are,” states the guidance.

After providing a legal overview of the requirements under the Food, Drug, & Cosmetic Act regarding promotional language, the draft guidance offers insight into what FDA looks for in risk-related materials for drug products. Specifically, states the guidance, the agency focuses on the promotional item’s “net impression (i.e., the message communicated by all elements of the piece as a whole),” according to the draft guidance. “Manufacturers should therefore focus not just on individual claims or presentations, but on the promotional piece as a whole,” advises the guidance.

The document describes a few examples, including one in which a full-page drug advertisement notes benefits in large type at the top of a page with risk information in small type at the bottom of the page. The draft guidance says the reader may perceive the product’s benefits to be greater than its risks based on the ad’s impression.

The draft guidance goes into detail on how FDA reviews promotional materials such as the language used for consumers (e.g., “fainting” versus “syncope”), the presentation of headlines and subheds, and the way risk information is conveyed in terms of focusing on the negative or positive aspects. The document also discusses, among other factors, the relevance and location of presented risk-information, the impact of an ad’s format such as font or its length such as a 30-second versus a 60-second commercial on the consumer, the target audience, and the information contained in package inserts.

“The agency hopes that by discussing the most relevant factors and by providing specific examples, manufacturers will gain a better understanding of what they should consider as they develop the content and format of their promotional communications,” concludes the draft guidance.

Source:pharmtech.findpharma.com

US warns of TV drug ads' distracting music, images

Television ads for drugs and
medical devices should avoid distracting images and music that
can reduce viewers' comprehension of potential side effects,
U.S. regulators advised in guidelines proposed on Tuesday.

 Advertisements also should use similar type styles and
voice-overs when conveying benefits and risks, the Food and Drug
Administration said.

 The guidelines follow complaints that manufacturers use
various techniques in their widely seen television ads and other
promotions to downplay risks while emphasizing potential
benefits.

 Leaving out or minimizing side-effect information is the
most frequent violation the FDA cites in letters to companies
complaining about misleading promotions.

 The draft guidelines advise manufacturers on how to present
risk information adequately in print and broadcast promotions to
consumers and doctors without running afoul of federal
regulations. The guidelines are not mandatory.

 The advice covers techniques ranging from the use of
contrasting colors to highlight information, the location and
timing of risk details and other factors that can influence how
well viewers understand a product.

 Prescription drug ads have drawn fire for portraying
healthy-looking, active and smiling patients while explaining
benefits and then rushing through or providing distractions when
required risk information is conveyed.

 At a congressional hearing last year, a Schering-Plough Corp
(SGP.N) ad for allergy drug Nasonex drew criticism for featuring
a bee that flew around during a description of side effects but
simply hovered while benefits were explained.

 In the new guidelines, the FDA said busy scenes, frequent
scene changes and moving camera angles "can misleadingly
minimize the risks of the product being promoted by detracting
from the audience's comprehension."

 The FDA also warned against speeding up an announcer's
description of risks. "If risk information is considerably more
difficult to hear and process than benefit information because
it is presented at a much faster pace, the piece will not convey
an accurate impression," the agency said.

 Reviewers will consider "the net impression conveyed by all
the elements of a piece. For this reason, manufacturers should
focus not just on individual claims or presentations but on the
messages conveyed by the promotional piece as a whole," the
guidelines said.

 Groups representing drug and medical device makers said they
were still reviewing the FDA guidelines.

 Drug companies "remain committed to producing responsible,
balanced promotional materials" and have adopted voluntary
guidelines that say risks "should be presented in clear,
understandable language without distraction," said Ken Johnson,
a spokesman for the Pharmaceutical Research and Manufacturers of
America. The group represents Pfizer Inc (PFE.N),
GlaxoSmithKline PLC (GSK.L) and other drugmakers.

 Medical device manufacturers also have adopted voluntary
advertising principles that include "the need to present risk
information in a manner free from distraction," said Wanda
Moebius, spokeswoman for the Advanced Medical Technology
Association, which represents Medtronic (MDT.N), Johnson &
Johnson (JNJ.N)and other device makers.

Schering-Plough spokeswoman Julie Lux said the company
reviews all its promotional material "to ensure it complies with
FDA regulations."

 The FDA guidelines were posted on the agency's website here.
(Reporting by Lisa Richwine, editing by Dave Zimmerman and
Matthew Lewis)

Source :Reuters

FDA Issues Proposed Ad Guidelines For Drugs, Medical Devices

The Food and Drug Administration Tuesday issued proposed advertising guidelines for drug and medical device makers with suggestions about how to properly present risk information in promotional material aimed at consumers and health-care professionals.

The draft guidelines, posted on the agency's Web site Tuesday, aren't binding, but they contain several suggestions to industry on how to avoid running afoul of agency rules. The FDA said the mission or minimization of risk information is the most frequent violation of the regulations cited in dozens of enforcement or warning letters sent to sponsors each year.

The agency said, "the public health is best served when risk and effectiveness information about drug and device products is clearly and accurately communicated."

While trade groups for both drug and medical device makers have recently established their own advertising guidelines, the FDA said the industry has asked the FDA for advice on how to comply with FDA rules, which require that information about effectiveness and risk be presented in a balanced manner.

The FDA said it looks at the "net impression" of a consumer advertisement or material given to doctors to determine if a piece conveys accurate information about a particular product.

The FDA said promotional material can be misleading even if specific individual claims or presentations aren't misleading. As an example, the FDA said an advertisement for a cholesterol-lowering drug that uses audio to lay out the drug's side effects could be considered misleading if it contains upbeat music and "discordant" images of patients benefiting from the medicine while the risk information is detailed.

The 24-page guidance document goes into detail about how fonts, the type of contrast and white space used in print materials can be used to best present risk information.

The guidelines suggest a product that requires monthly blood tests to check for liver damage should state that in clear language rather than using statements that state there's a need for "certain monitoring."

The agency will be accepting comments on the draft guidance document for 90 days before it issues final guidelines. The draft guidance document is set for publication in Wednesday's Federal Register.

Source: Nasdaq