A Medical Device Daily

The FDA this week said that it plans to form a new advisory committee designed to counsel the agency on how to strengthen the communication of risks and benefits of FDA-regulated products to the public.

Called the Risk Communication Advisory Committee, the group has several goals:

• help the agency to better understand the communication needs and priorities of the general public;
• advise the agency on the development of strategic plans to communicate product risks and benefits;
• and make recommendations to the agency on what current research suggests about crafting risk and benefit messages, as well as how to most effectively communicate specific product information to vulnerable audiences.

“Communicating the risks and benefits associated with FDA-regulated products is essential to help consumers and health care professionals make informed decisions,” said Randall Lutter, PhD, FDA’s acting deputy commissioner for policy. “The Risk Communication Advisory Committee will bring together a broad range of experts and views to help improve FDA’s communication of the science-based information about product risks and benefits that the public needs to make informed decisions.”

The FDA said that the establishment of the advisory group “stems from the 2006 report of the Institute of Medicine (IOM; Washington), ‘The Future of Drug Safety: Promoting and Protecting the Health of the Public.’”

(Though not acknowledged by the FDA, criticism of the agency’s handling of device recalls — primarily of implantable defibrillators — has also driven the need to establish better methods of risk communications, threats and recall advisories.)

The IOM report recommended that Congress enact legislation establishing a new advisory committee to address how FDA communicates information about the efficacy, safety and use of drugs and other FDA-regulated medical products.

FDA said that it “agreed with the value of such a committee and acted promptly to establish it through more speedy administrative procedures.”

Importantly, it said it also expanded the scope of the committee to cover “communication of risks and benefits of all products regulated by the agency.”

The committee will be made up of 15 voting members that include experts and public members who are not affiliated with the FDA. Experts will include authorities knowledgeable in the fields of risk communication, social marketing, health literacy, cultural competency, journalism, bioethics, and other relevant behavioral and social sciences. Public members will include those who can provide the perspective of users of FDA-regulated products, such as consumers, patients, caregivers and health professionals.

Two related Federal Register notices are being published, one announcing the establishment of the new advisory committee and the other requesting nominations for members to serve on the committee. For information: http://www.accessdata.fda.gov/scripts/oc/ohrms/advdisplay.cfm.

Nominations for advisory committee members received on or before 45 days after the Federal Register publication will be given first consideration for membership.

AdvaMed lauds Bush on Japan policy

The Advanced Medical Technology Association (AdvaMed; Washington) has issued a statement praising the Bush Administration for securing commitments from Japan to improve its reimbursement and regulatory practices for medical technologies.

These measures were outlined in a joint report on deregulation presented to President George W. Bush and Japanese Prime Minister Shinzo Abe on June 6.

AdvaMed said that the goal of the measures “is to promote smoother introduction of new technologies and expanded access for U.S. companies to the Japanese market.

Stephen Ubl, president/CEO of AdvaMed, said that the measures “will provide greater transparency, reduce regulatory delays and improve Japanese patients’ access to the latest life-saving and life-enhancing medical technologies We are pleased that the two governments recognize the vital contributions that advanced medical technologies can make to Japan’s health care challenges.”

AdvaMed says that Japanese patients do not have access to the innovative technologies available to patients throughout the rest of the world because of “bureaucratic delays and burdensome regulations” that drive up costs “without improving healthcare quality.”

It says that the ITC , an independent U.S. Government agency, conducted an extensive investigation of the regulatory environment in Japan and found that the process of gaining access to Japan’s medical technology market is far slower and more costly than that of the U.S. or the European Union, and that Japan has been cutting reimbursement for innovative medical technologies through a system that focuses on products made mainly by non-Japanese companies.

Among the measures announced by the two governments, Japan has agreed to consult with industry before making any changes in it rules for setting medical device reimbursement prices.

It said that Japan also committed to increase its efforts to speed the introduction of medical technology products through its approval system so that Japanese patients can benefit from these advanced treatments as quickly as possible.

Siemens’ MRI/PET technology a ‘big step’ in diagnostic imaging

If the development of a computed tomography/positron emission tomography (CT/PET) imaging system was a small step for diagnostic imaging, a system capable of performing simultaneously MRI and PET is a giant leap, according to Wilfried Loeffler, PhD, senior VP of clinical R&D for Siemens Medical Solutions (SMS; Berlin).

SMS recently reported a prototype for what it calls the “world’s first” MRI/PET system able to perform these functions simultaneously and terming it a turning point in diagnosis and therapy for those suffering from neurological diseases, stroke and cancer. Testing of the new prototype MR/PET will start before the end of 2007, SMS said.

“In comparison to [PET/CT] this is extremely complex,” Loeffler told MDD. That’s because in PET/CT the two systems are simply sandwiched together, not done simultaneously, he explained.

“PET/CT technologically was a small step — this is a big step,” he said.

SMS said its MRI/PET prototype brings the “exceptional soft tissue contrast and high specificity of MRI together with PET’s excellent sensitivity in assessing physiological and metabolic state.”

The researchers expect MRI/PET to open new doors in understanding the pathologies and progression of Alzheimer’s, Parkinson’s, epilepsy and various psychic disorders. For example, PET can differentiate mild cognitive impairment from early-stage Alzheimer’s, but cannot determine reduced brain volume caused by atrophy. By combining PET with MRI, clinicians may be able to make a better determination of both cognitive impairment and atrophy.

In stroke patients, the technology holds the promise of enabling physicians to study, post-stroke, which brain tissues might be salvageable. In other rehab settings, such as for traumatic brain injury, MRIPET would improve care and workflow, the company said, because requiring just one scan and not having to go to different locations for two scans.

He said that MRI/PET holds promise for emerging therapeutic research as well, for instance in the development of stem cell therapies. By allowing simultaneous measurement of anatomy, functionality and biochemistry of the body’s tissues and cells, it may enable researchers to correlate data in a way not previously possible.

— Amanda Pedersen