Update January 11, 2017- By Steven E Greer, MD
Last November, I sent my idea, below, directly to the Commissioner of the FDA, Robert Califf. I also sent it to some senior media advisors for the Trump transition team.
Today, in his first press conference, President-elect Trump mentioned how he plans to bring back to the US drug manufacturing jobs. No other news outlet or industry trade journal has discussed this novel idea other than The Healthcare Channel.
September 4, 2010- by Steven Greer, MD
The Commissioner of the FDA, Margaret Hamburg, could become the single biggest job creator in the Obama administration and generate 100,000 new jobs within 12-months. How?
Pharmaceutical and medical device manufacturing, as well as clinical trial development, have been outsourced to China, India, Ireland, and other countries, taking with it the jobs required to do these functions. According to the Bureau of Labor Statistics, there were 300,000 jobs involved in pharmaceutical manufacturing alone back in 2008. Data are not readily available on the number of people employed in non-U.S. drug and device plants, but the FDA exclusively told us that there are 7,321 non-U.S. medical device manufacturing plants they track/inspect and 9,422 non-U.S. drug manufacturing plants. Therefore, the number of jobs that are outsourced to these plants, to make drugs/devices that are then imported to the U.S., seems to be well into the hundreds of thousands.
Therefore, the number of jobs that are outsourced to manufacture drugs and device, that are then imported to the U.S., seems to be well into the hundreds of thousands.
Monitoring safety is the primary mandate for the drug and device divisions of the FDA. It has become increasingly more difficult for the FDA to properly monitor all of these overseas plants. We recently spoke with the Commissioner of the FDA and the Director of CDER about this.
The FDA recently added a fee to the drug industry to allow the FDA to hire more overseas inspectors in the wake of numerous drug safety horrors, such as counterfeit Chinese-made heparin that killed hundreds and resulted in the execution of the director of China’s equivalent of the FDA. However, the new number of FDA inspectors will still only inspect a small fraction of the overseas plants, according to the GAO.
A much more effective solution would be to mandate that the majority of drugs and devices be made right here in the United States. How many jobs could be rapidly created by such a decree? One can easily imagine 100,000. As Roche assimilated Genentech like a Star Trek Borg, it eliminated as many as 8,800 employees at just one plant in Vacaville, California when it outsourced the biologics manufacturing to Singapore.
Making drugs meant for Americans in American plants is the only sensible thing to do from a safety standpoint. But the financial power of K Street drug industry lobbyists has allowed the rules to become relaxed so much that we now have the vast majority of our pharmaceuticals being made in China and India.
It would not have been conceivable to change this practice of outsourcing drug manufacturing. However, with the prolonged economic depression and 10% unemployment for the foreseeable future, the political climate might just allow such a bold regulatory change.
Of course, such a radical change by the FDA would require presidential and congressional support. This could be the most effective and bipartisan popular move the President can make.