The FDA's Office of Combination Products unveiled a new proposal last month on how it plans to assign the lead center that will be charged with premarket review and regulation of combination products. Combination products are defined as containing a combination of a drug, a device or a biological product. This category of technology can prove challenging for the FDA and industry because these products often do not fit neatly into traditional categories of regulated items. For example, products in this sector include drug-eluting stents, which combine a drug with a medical device; orthopedic implants with genetically engineered human protein; and antibiotic bone cement.
The FDA said the proposed rule has two purposes. The first is to codify the definition of primary mode of action (PMOA), which is the measurement the agency has used for more than a decade when assigning combination products to a particular center within the agency for review. Depending on whether the product was a biological product, device or drug, it would be referred to the Center for Biologics Evaluation and Research, the Center for Drug Evaluation and Research or the Center for Devices and Radiological Health, respectively. The second goal is to simplify the assignment process by providing a defined framework for sponsors to use when recommending the PMOA and assignment of a combination product to the FDA.
"We do hope this will streamline the process by giving sponsors a more concrete idea of what it is we look for," a spokesperson for the Office of Combination Products told The BBI Newsletter. The spokesperson would not estimate what kind of time savings this would translate into for the regulatory process, but he did say that informal industry feedback following the announcement has been overwhelmingly positive. "The biggest difference is now we'll have a formal definition where we didn't before," the spokesperson said.
Under the new proposal, the FDA says the PMOA would be defined as the "single mode of action (e.g., drug, device, biological product) of a combination product that provides the most important therapeutic action of the combination product." According to the FDA, "therapeutic" includes "any action or effect of the combination product intended to diagnose, cure, mitigate, treat, or prevent disease or affect the structure or any function of the body." Previously, the FDA required sponsors submitting a request for assignment of a combination product to identify the PMOA of the product and recommend a center within FDA to take the lead in the product review. According to the agency, the proposed rule provides an expanded regulatory definition it hopes will clarify the process for assigning these products.
For the device sector, the product would have a device mode of action if it "does not have a biological product mode of action, does not achieve its primary intended purposes through chemical action within or on the body, and is not dependent on being metabolized for the achievement of its primary intended purposes."
If it is not possible for either the agency or the product sponsor to determine which mode of action serves to provide the most important therapeutic effect at the time a request for assignment is submitted to the FDA, the agency will assign the product to a center that regulates other combination products presenting similar questions of safety and effectiveness with regard to the combination product as a whole. When there are no other combination products that present similar questions, the product would be assigned to the agency component with the most expertise to evaluate the safety and effectiveness questions presented by the combination product, the FDA said.
The spokesperson said these are the same criteria that were used in the past, but they now have been given a more formal framework in the regulatory process. "Industry wanted to have something more tangible to be able to think about when they put together a recommendation for assignment for a lead center based on primary mode of actions, and FDA wanted to have something in place that we could look to."
VA to overhaul aging facilities
The Department of Veterans Affairs (VA; Washington) has announced a plan to overhaul its aging healthcare system. The plan includes new hospitals in Orlando, Florida, and Las Vegas, Nevada, in addition to 156 new community clinics, four spinal cord injury centers, two rehabilitation centers for the blind and expanded mental health outpatient services throughout the country. This modernization plan will cost roughly $1 billion annually during the next several years, the department said, and is the result of a three-year review of the VA's system called Capital Asset Realignment for Enhanced Service, or CARES. The program assessed veterans' current healthcare needs and then evaluated recommendations to meet those needs in the future. In addition to creating new facilities, the expansion and upgrading also calls for transferring care from antiquated facilities to more modern or better-located VA facilities and contracting for care in local communities.
New and expanded facilities mean an opportunity for medical technology companies. A spokesperson for the VA told BBI that while no precise dollar amount had been earmarked for any specific technology, a program this broad is bound to impact the device sector. "Rural areas of the county will especially see a difference," the spokesperson said. "There will be increased use of telemedicine." The VA expects to increase the percentage of enrolled veterans from 28% of the total veterans' population today, to 30% in 2012 and 33% by 2022. In August of last year, the VA released the 100-page draft of the national plan, which then was reviewed by an independent, 16-member CARES commission. The commission reported its recommendations to Secretary of Veterans Affairs Anthony Principi in February after conducting more than 40 public hearings and meetings, hearing from more than 700 witnesses and receiving written comments from more than 200,000 people.
"CARES allowed us to identify the infrastructure that VA needs to care for veterans in the 21st century," said Jonathan Perlin, MD, the VA's acting undersecretary for health. "We'll be able to spend more of our resources on doctors, nurses and medical care, instead of building maintenance." Perlin also said the realignment will help the VA avoid imbalances in its services in the future, by making sure the size and location of its facilities match the needs of veterans.
In 1999, the General Accounting Office estimated that the VA diverted $1 million dollars a day from care to maintenance of unneeded or unused facilities. According to the department, most of its facilities are more than 50 years old, although the industry standard for healthcare facilities in the private sector is less than 10 years old. Last year, according to department statistics, VA healthcare workers treated about 4.8 million patients, up from 2.9 million in 1998. President George Bush's budget requests $29.5 billion for VA's medical care for next year, which is more than 40% above the level in 2001.
HHS forms med-tech task force
The Department of Health and Human Services (HHS; Washington) in late May said it is forming a multi-department task force charged with speeding the development of medical technology. The task force will involve the FDA, the Centers for Disease Control and Prevention (CDC; Atlanta, Georgia), Centers for Medicare & Medicaid Services (CMS; Baltimore, Maryland) and the National Institutes of Health (NIH; Bethesda, Maryland). According to HHS, the group will be charged with promoting new solutions and to encourage innovation in healthcare, while decreasing the development time of new medical technologies, such as medical devices, biologics and drugs.
HHS said that given the number of different organizations engaged in medical development research, the amount of money spent each year in the near future could approach $100 billion. Hence, one of the task force's goals will be to determine how industry and government might use those funds more effectively. "This task force will look for opportunities across the department to promote speedier access to new innovative medical technologies that can improve people's health and save lives," HHS Secretary Tommy Thompson said in a statement. "Often, a new technology must clear several hurdles in different parts of HHS before it can reach consumers."
He has asked the task force to issue a report this year on appropriate steps that can be taken across the department to speed availability of new products. Task force work will build on similar efforts underway at the FDA and other agencies, with a goal of improving coordination across agencies. As part of a similar effort, the FDA initiated its Critical Path program in March to address ways in which the product development cycle could be modernized to make it more predictable and less costly.
Conflicts of interest draw new scrutiny
In light of recent questions about possible conflicts of interest involving scientists at the National Institutes of Health, FDA Acting Commissioner Lester Crawford has directed a comprehensive review of all current outside consulting requests from FDA employees. Once the review is completed, the agency it will issue a final policy on the review and approval of such agreements, Crawford said. The issue surfaced last December when the Los Angeles Times published an article detailing the decade-long practice of high-level NIH scientists receiving hefty fees for consulting with biotechnology and pharmaceutical companies. Congressional committees, including the House Energy and Commerce Subcommittee on Oversight and Investigations, have begun looking into the matter.
Under NIH policy, there is no limit to the amount of compensation or the number of hours a scientist can be paid for outside consulting jobs. Employees are not required to disclose what they are paid. Since other government departments operate under similar rules, the subcommittee members said they would investigate those departments as well. Meanwhile, the FDA's current policy allows employees to contract their services with the permission of mid-level managers. Crawford believes that authority should be delegated to a higher level; therefore, he has implemented an interim policy requiring center directors to review and approve all outside activity requests. Since 1970, Crawford said, the FDA has had an aggressive disclosure and review process that is designed to ensure that its employees do not have any conflict of interest involving companies and entities that the FDA "significantly regulates."