Manufacturing Decline Yields Drug Shortages

Abstract

From our vantage point within the world of pharmaceutical development and manufacturing, we welcome your effort to draw attention to shortages of the irreplaceable cancer drug cytarabine (“Shortages of cancer drugs put patients, trials at risk,” J. Kaiser, News & Analysis, 29 April, p. [523][1]). The scarcity of not only cytarabine, but also numerous other drugs, is an urgent public health problem that both the drug industry and the government have an obligation to address. To do this successfully, both the causes and the solutions of this issue need to be understood in their broader context: the neglect of manufacturing, especially high-tech manufacturing, in the United States. The proximate cause of the most recent cytarabine shortage was a failure of production. However, what turned this error into a tragedy was a failure of the market. As the News story explains, the profit margin on generic drugs such as cytarabine is often very small. At the same time, the technical and regulatory burden—especially for cytotoxic sterile injectibles (again, like cytarabine)—is as substantial as it is for extremely profitable, brand-name drugs. Few businesses could be expected to enter such a market, and indeed, few have. In this respect, the pharmaceutical industry is far from exceptional. Business leaders like Andrew Liveris (CEO, Dow Chemical), Michael Porter (founder, Monitor Group), and Andy Grove (CEO, Intel) have sounded the alarm at the decline of America's manufacturing capacity. They note that manufacturing has a tremendous multiplier effect on economic growth and job creation ([ 1 ][2]–[ 3 ][3]). Nonetheless, a perfect storm of laissez-faire public policy and bottom-line business decisions has allowed the sector to atrophy. Constituents of both the public and the private sectors work under the mistaken belief that American firms can continue to innovate domestically while leaving manufacturing to someone else. The flaws in that logic are evident in our industry. We have seen that R&D and manufacturing are most effective when communication is reciprocal, the lessons learned in the plant feeding back to the drawing board (or the lab bench) ([ 4 ][4]). As a result, in many industries, where manufacturing goes, innovation tends to follow. The cytarabine shortage shows us that the wasting away of the U.S. manufacturing sector may not just shut us out of future prosperity; it can actively do harm in the present day. Today, across the United States, patients with leukemia are being told that they can't have the one drug that could extend or save their lives. We join with Liveris, Porter, and the like-minded thinkers mentioned in the News story in their call for more meaningful government incentives to make manufacturing in the United States a logical choice. Targeted incentives can be an investment not only in the future of the economy, but in the future of individual Americans as well. 1. [↵][5]1. A. Grove , “How America can create jobs,” Bloomberg Businessweek, published online 1 July 2010 ([www.businessweek.com/magazine/content/10_28/b4186048358596.htm][6]). 2. 1. A. N. Liveris , Make It in America: The Case for Re-Inventing the Economy (Wiley, Hoboken, NJ, 2011). 3. [↵][7]1. M. E. Porter, 2. M. R. Kramer , Harv. Business Rev. 89, 62 (2011). [OpenUrl][8][Web of Science][9] 4. [↵][10]1. P. R. Connelly, 2. B. P. Quinn, 3. P. Hurter, 4. J. Condon, 5. P. Mueller , Pharm. Outsourcing 11, 16 (2010). [OpenUrl][11] [1]: /lookup/doi/10.1126/science.332.6029.523 [2]: #ref-1 [3]: #ref-3 [4]: #ref-4 [5]: #xref-ref-1-1 View reference 1 in text [6]: http://www.businessweek.com/magazine/content/10_28/b4186048358596.htm [7]: #xref-ref-3-1 View reference 3 in text [8]: {openurl}?query=rft.jtitle%253DHarv.%2BBusiness%2BRev.%26rft.volume%253D89%26rft.spage%253D62%26rft.genre%253Darticle%26rft_val_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Ajournal%26ctx_ver%253DZ39.88-2004%26url_ver%253DZ39.88-2004%26url_ctx_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Actx [9]: /lookup/external-ref?access_num=000285569000030&link_type=ISI [10]: #xref-ref-4-1 View reference 4 in text [11]: {openurl}?query=rft.jtitle%253DPharm.%2BOutsourcing%26rft.volume%253D11%26rft.spage%253D16%26rft.genre%253Darticle%26rft_val_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Ajournal%26ctx_ver%253DZ39.88-2004%26url_ver%253DZ39.88-2004%26url_ctx_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Actx