Lobbying for Manufacturing Science

Nov. 22, 2005
The National Institute for Pharmaceutical Technology and Education’s goal is to obtain funding for research that may, ultimately, lower drug development and manufacturing costs.
By Agnes Shanley, Editor in ChiefThe petroleum industry’s current problems, and accusations of post-hurricane price fixing, have been the subject of wry jokes in some drug industry circles today. Finally, another corporate villain has eclipsed pharma. If both industries share low public ratings in the U.S., they have another thing in common: strong lobbies in Washington, a sore spot with many consumer groups today.The drug industry is lobbying the U.S. government on a number of issues, from fighting drug importation to battling price controls. Many of its causes are just, others may not be. But in November, a new lobbying group emerged with a message that should appeal to everyone, from big pharma to generics manufacturers and the public at large.
The National Institute for Pharmaceutical Technology and Education (NIPTE), established by Purdue University with the involvement of several leading universities, drug manufacturers and the FDA, plans to create a collaborative scientific environment to change the way drugs are developed and produced in the U.S.It is certainly no secret to any of you that the costs of commercializing a new drug have risen by 50% within the past five years, and can now reach $1.7 billion. Meanwhile, the number of new drugs in the pipeline has shrunken by the same amount.Drug companies are forced to focus on products, and markets, that bring the greatest economic returns. In the process, orphan drug therapies for select groups, and development of the drugs needed for diseases that threaten many developing nations, remains a low priority.The public might argue that pharma’s pockets are deep enough to cover these additional research costs, but arguing that point is likely to go nowhere. Just as government funding of work at NIH and university laboratories led to the blockbuster drugs of the 1990s, a focused effort involving government, academia and industry can only improve the state of drug scaleup and manufacturing science.As Charles Rutledge, vice president for research at Purdue University and one of NIPTE’s founding members, was quoted by the press after the organization’s launch, “Development and manufacturing processes have become so complex that it is becoming more difficult to provide safe and effective drugs at significantly lower cost to patients.”Fundamental research may change this picture, and bring the same level of sophistication to development and manufacturing that are applied to discovery. Members are providing funding, but each university member is also seeking federal funding.The new group is headed by a diverse board of directors, including professors from Illinois Institute of Technology, the University of Puerto Rico, and the Universities of Maryland, Connecticut, Kentucky, Iowa, Kansas and Minnesota, as well as Duquesne and Purdue.While the key focus will be on improving the science of development and manufacturing, an important side benefit will be improved training for future industry professionals and regulators in the science-based principles needed to stop “gridlock” and allow efficiencies to improve and costs to come down. On the economic side, the group could have a long-term impact by ensuring that innovations continue to be born in the U.S., and that more jobs remain here as well.To paraphrase NIPTE’s official statement, “Today, FDA regulations are tight, the costs of re-approval of process innovations are high, and the level of science-based understanding of pharmaceutical materials and manufacturing steps is inadequate. This situation ensures that, once a manufacturing process is approved, it is left substantively unchanged for the duration of a product’s life. As a result, the beneficial learning curves and associated progressive cost reductions typical of products sold in [other industries] doesn’t occur. Instead, product costs only increase, as energy, input materials, marketing and labor costs rise.”PAT will presumably be a key item on the new group’s agenda. I urge you to support NIPTE in any way possible. For more information, please visit its web site at www.purdue.edu/dp/nipte/why.php.