FDA Unveils Database of Drug Side Effects, Procedural Changes

It could be argued that the pharmaceutical and medical products industry—with its high-value, high-regulation product lines—could have the most at stake for achieving operational excellence. Regulatory requirements have risen for this industry struggling to hold down cost.

Today, the Food and Drug Administration unveiled a new effort to bolster its oversight of drugs after they're on the market, in the agency's latest response to years of criticism about its handling of medication safety issues. Ultimately, the FDA is supposed to implement a second phase to the plan, called Safe Use, that will focus on ensuring that drugs are used safely in the real world. But the agency official said there were few details available yet about the plan.

Among other changes, the plan, dubbed "Safety First," involves creating a new database listing possible side effects of drugs, along with clear schedules for following up on questions about them. Also, the FDA plans to make changes to its procedures for making certain regulatory decisions, particularly those based on emerging safety worries, though the new moves don't go as far as some critics have advocated. The FDA plans to grant some new powers to the office that focuses largely on the safety of marketed drugs, known as the Office of Surveillance and Epidemiology. Republican Sen. Chuck Grassley of Iowa, among others, has raised concerns about the agency's current decision-making process, because regulatory power over drugs once they are approved rests primarily with the same drug-review divisions that decided to approve them for marketing in the first place. The plan was announced to FDA staff in an email today, and the agency is expected to testify about it tomorrow on Capitol Hill.

The new moves stop short of divorcing the two functions. The safety office will not get the ultimate power to sign off on label changes or recommendations to remove a drug from the market.

The agency will have multidisciplinary groups, including the pre-market review division and the safety office, come together to make decisions. If one office disagrees, it can appeal to higher-level officials. Currently, while this may often occur, it is more ad-hoc. Also, the pre-market drug-review divisions will each get their own new, dedicated officials whose responsibilities focus on safety.

The drug safety office will get primary authority over decisions to approve drug brand names and packaging, though this change will not occur immediately. Eventually, the safety office is supposed to formally get another power as well: the ability to commission certain kinds of research, the epidemiological studies often drawn from patient databases. This could involve requiring drug makers to do such studies -- a power the FDA gained under a new law passed last year -- or contracting with outside sources.

We help your organization keep compliance standards at their highest, while holding costs in check. Our services help companies achieve world-class regulatory compliance and drive operational excellence throughout their organizations.

No World Borders has developed several service offerings by combining our deep industry experience with pioneering technology and capabilities. We work with our clients to achieve sustainable, long-term, integrated solutions at lower cost aligning strategy with people, processes and technology. We aim for speed to value through extensive experience, pre-packaged materials and fast implementation. Our Health & Life Sciences industry group works with clients to ensure that patient need is at the center of everything they do. Within pharmaceutical and medical products, providers, payers and public service health we are transforming global health care by connecting information, insights and technology to improve the quality of the patient experience. Process improvement is at the forefront of No World Border's competencies, which are critical in highly regulated industries.

Efficient Real Estate - Workplace Management

While no one person invented lean, no one is given more credit than Taiichi Ohno, father of the Toyota Production System. Many lean students would want nothing more than to spend a day with Taiichi Ohno walking through their plant. Real estate and related plant and material is typically the most valuable tangible asset companies have.

The workplace has experienced dramatic changes in the last ten years. Worker mobility enabled by network and wireless technology has revolutionized work styles and workplace culture that require new system support tools and services. Global terrorism has radically increased focus on disaster recovery and business continuity to the extent that workplace resiliency is no longer an option. The intense focus on business compliance, specifically via the requirements of Sarbanes-Oxley, demands new levels of transparency and data integrity relative to workplace processes and costs. And the "green revolution" centers on workplace sustainability, particularly relating to energy efficiency, and long-term sustainability of enterprise buildings and workplace environments. These trends coupled with a continued drive toward workplace cost containment, worker productivity and asset efficiency have now risen to the senior executive agenda, demanding new levels of sophistication, precision and excellence in the management of workplace assets, services and processes.

Integrated Workplace Management Systems (IWMS) and the Enterprise Asset Management (EAM) markets altered considerably over the last two years. The IWMS market experienced rapid growth and is expected to grow at 10 percent a year, according to Gartner Group. The EAM market landscape has had a face lift; virtually every EAM vendor has been acquired in the past two years, but none of them have been consolidated, so there are still just as many as before. In addition, these two areas have grown somewhat closer together, as more assets are becoming IT-enabled.

The IWMS market focuses on enterprise-level software applications that integrate four key areas: project management, real estate portfolio and lease management, space management, and maintenance management. The software typically operates from a single database and offers work flow tools, executive dashboards, and pre-defined and customized reporting capabilities for multiple sites. Most of these applications can inter-operate with other enterprise applications, such as ERP, supply chain management and human capital management via Web service technologies.

EAM offerings, a subset of ERP systems, evolved from computerized maintenance management systems (CMMS) and primarily center around materials and maintenance management functionality. These offerings tend to be simpler in scope than traditional CMMS offerings and focus on single-site deployments. Functionality also focuses on planning and execution.

According to Gartner, IWMS covers things like real estate, space utilization, leasing, rental, and some areas of facilities management. Companies investigating IWMS should consider those firms in the upper right quadrant of Gartner’s charts. No World Borders helps clients discern the leaders that fit for your firm, and provide consultation services to help select, implement, and facilitate the change processes to optimize your ability to capitalize on the investment in an IWMS.