Financial accounting rules are blocking manufacturers from providing vaccines for national stockpiles, while liability concerns are discouraging investment in new products and manufacturing operations. Industry complains that increasingly stringent good manufacturing practices (GMP) standards delay production and raise costs. Policy makers are weighing legislative proposals to address some of these issues, but disagreement over legal and manufacturing issues may block speedy agreement on needed changes.
In January of this year, CDC's National Vaccine Advisory Commission (NVAC) held a two-day workshop to examine perennial problems jeopardizing the US vaccine supply. NVAC addressed many of these concerns three years ago and published a report in the Journal of the American Medical Association (JAMA, Dec. 17, 2003; 290: 3122-3128) outlining strategies to improve vaccine development and distribution. The report called for policymakers to:
MANUFACTURING HURDLES Although regulators and manufacturers agree on the need for vaccine production facilities to meet rigorous quality standards, industry executives complain that overly inflexible GMP requirements block innovation and expansion. At the workshop, Norman Baylor of FDA's Office of Vaccines Research and Review in the Center for Biologics Evaluation and Research (CBER), cited the agency's two-year GMP modernization initiative for streamlining manufacturing regulatory processes, including the agency's Team Biologics inspection program. He noted that CBER is encouraging fast-track and accelerated approval approaches to speed innovative vaccines to market, but he also acknowledged that tight budgets are preventing the agency from doing much more than meet required review goals and deal with the most pressing problems.
Manufacturers at the meeting agreed that CBER requires more resources to support a critical scientific base capable of dealing with the technological advances that will shape future vaccine development. At the same time, they complained that regulatory requirements aggravate supply problems and add to the cost and time needed to develop new products. Alan Shaw of Merck noted that the agency is requiring larger and larger safety studies, which still are unlikely to reveal really rare adverse events. Vax-Gen CEO Lance Gordon described how very costly it was to build a GMP-compliant plant to produce an anticipated 75 million doses of its new recombinant anthrax vaccine. Escalating GMP requirements, Gordon observed, erect barriers to entry for smaller biotech firms and make it hard to obtain clinical supplies for early studies.
Despite harmonization efforts, Peter Paradiso, vice president at Wyeth Vaccines, explained that US and EU manufacturing standards still focus on different areas, prompting manufacturers to meet the most stringent requirements to avoid future problems. He urged more balance between safety concerns and public health, with product specifications and requirements geared to enhancing product quality.