Q: What type of economic incentives would you propose to spur antimicrobial drug development?
There is a growing (and appropriate) need for antibiotic stewardship, which is the reluctance to use new, powerful antibiotics when older ones might be used first (until and unless there is clear evidence of antibiotic resistance). This state of affairs is referred to by economists as “market failure.” Thus, while we need a continuous supply of new antibiotics, because of evolving and inevitable resistance, pharmaceutical companies are reluctant to invest. Glimmers of hope, though, exist, among them the recently passed GAIN Act by the U.S. Congress as part of PDUFA V. The GAIN Act provides companies developing new antibiotics for serious and life-threatening infections due to resistant organisms an additional five years of marketing exclusivity along with FDA fast track and priority reviews, simulaneously helping the economic outcome and reducing the regulatory risk. This new act is a model for how government, at times of market failure, can intervene in helpful ways.
Barry Eisenstein, M.D. is senior VP of scientific affairs at Cubist Pharmaceuticals and editor of Antimicrobial Agents and Chemotherapy.
Q: What is your opinion of the California e-Pedigree law and its impact on securing the supply chain?
The California e-Pedigree Law will certainly improve the security of the drug supply chain and make it more difficult to introduce counterfeit drugs into the system. However, full implementation is not scheduled until July 2017. Producers of counterfeit drugs, if so inclined, will figure out how to circumvent the system. The effectiveness of the law is also dependent on proactively checking the integrity of the pedigree through the supply chain. Either through laxity in vigilance — assuming someone else in the supply chain has checked the pedigree — or overt desire to source “cheap” drugs, the system could be subverted. While not necessarily the “final solution,” the law is a major step forward and should improve traceability if and when a problem arises.
Norman Klein is the principal at Core Results, LLC, which offers consulting in the areas of purchasing and supply chain optimization. He has more than 35 years of experience in purchasing, engineering, finance, manufacturing, and distribution.
Q: What impact do you think recent well-publicized drug failures will have on future research initiatives?
Today’s investment for compounds in Phase 3 is enormous, and the FDA requires more long-term safety data before approval. In addition, they are asking for studies showing that a potential new drug does not just show an impact on a disease marker, such as lowering bad cholesterol or plasma sugar levels; they are also requiring drugs have a meaningful effect on slowing or halting the disease. In addition, payers are demanding that new drugs show benefits over existing medications. Such head-to-head comparisons also require expensive clinical trials. In some ways this will impact future research initiatives. However, the higher hurdles will not necessarily mean that high-risk projects will be abandoned. While more care will be taken before such a commitment, CEOs realize that pharma R&D is a high-risk/high-reward business.
John LaMattina, Ph.D. is the former senior VP at Pfizer Inc. and the president of Pfizer Global Research and Development. In this role, he oversaw the drug discovery and development efforts of over 12,000 colleagues in the United States, Europe, and Asia.
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