In January, President Donald Trump said, “We have got to get our drug industry back.” Later that month, at a meeting in the Oval Office with executives of eight large innovator pharmaceutical companies, he said he wanted them to bring drug prices “way down,” and promised to curb regulations and lower tax rates to boost their competitiveness.
We are encouraged by these developments and consider these efforts as only the first steps by the president to understand the challenges of domestic pharmaceutical manufacturing. Furthermore, the nomination of Scott Gottlieb to lead the Food and Drug Administration adds to our encouragement. Gottlieb was the at the FDA during the time when the FDA launched its initiative the Pharmaceutical CGMPs for the 21st Century. To that end, we offer some points to consider in efficiently catalyzing a renaissance of a technologically modern, efficient, high quality, and profitable pharmaceutical manufacturing in the United States.
- Generic medicines must be part of the conversation. To encourage U.S. pharmaceutical manufacturing and for it to become a contributing factor in reducing drug costs, President Trump and the FDA must include manufacturers of generic medicinal products in their efforts and policy cogitations and actively confront critical assumptions about pharmaceutical manufacturing.
- Manufacturing quality counts. An often unchallenged assumption is that pharmaceutical manufacturing is but a stepchild to discovery and development. And the truth is that manufacturing does not attract a CEO’s attention, except when there’s a serious problem. You only need to look at the Wall Street Journal’s Sept. 3, 2003, article which clearly described this challenge: “The pharmaceutical industry has a little secret: Even as it invents futuristic new drugs, its manufacturing techniques lag far behind those of potato-chip and laundry soap makers.”
- We must address the regulatory burden. Innovation and continual improvement in pharmaceutical manufacturing are hard to accomplish because of a risk-averse mindset, which is deeply ingrained in the industry. A sustained high level of “regulatory uncertainty” — i.e., fear of delay in the FDA approval process, is responsible for this undesirable mindset. We believe that the president’s direct involvement with pharmaceutical CEOs is perhaps the most powerful means to change both the perception and the reality of the FDA as a partner, rather than sea anchor to domestic manufacturing innovation.
- President Trump and the FDA have the opportunity to create a tipping point for a pharmaceutical manufacturing renaissance in the U.S. The FDA actively working to reduce regulatory burden will be essential to sustain the momentum. Such regulatory reforms should be informed by science and engineering, promote utilization of new technologies and ensure objective risk-management methodologies.
- Science Counts. Many aspects of science, engineering, and technology are needed to facilitate sensible regulatory reforms. The 21st Century Cures Act has recognized the need to support academic programs to build technological solutions such as continuous manufacturing of drugs and biological products and similar innovative monitoring and control techniques.
- We must admit and address our weaknesses. Our pharmaceutical supply chain has many inherent vulnerabilities. Consider the December 2013 congressional testimony of FDA drug chief Janet Woodcock. According to Woodcock, “Use of foreign-sourced materials creates vulnerabilities in the U.S. drug supply.” She also urged the nation’s policy makers to be strategic in leveraging new technological opportunities. She emphasized that “[t]hese new ways of making drugs could, with the proper strategies, revitalize pharmaceutical manufacturing in the United States.”
- We need alignment and prioritization of research, education and policy efforts. To realize right-first-time development and manufacturing of generic drugs in the U.S. we must work to identify and aggressively address vulnerabilities in the U.S. drug supply. In doing so, pharmaceutical manufacturing in the U.S. will become a contributing factor in reducing drug costs. After all, the most expensive drug is the one that doesn’t work because of poor quality.
Today there is an unprecedented juxtaposition of key forces, necessary for a domestic pharmaceutical manufacturing renaissance: President Trump’s focus on U.S. manufacturing, the progress in pharmaceutical technologies such as continuous manufacturing and real-time controls, and legislative recognition of the need for efficient pharmaceutical manufacturing as in the 21st Century Cures Act. Let us not underestimate how exceptional this celestial alignment can be for efficiently catalyzing technologically modern, efficient, and profitable pharmaceutical manufacturing in the United States.
Ajaz Hussain, a former FDA deputy office director, is president of the National Institute for Pharmaceutical Technology and Education, Inc. Vadim Gurvich is executive director of NIPTE. Peter J. Pitts, is president of the Center for Medicine in the Public Interest and a former FDA associate commissioner.
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