Is this really happening?


So I got a press announcement from FDA this week announcing it was embarking on a “major hiring initiative” to fill more than 1,300 positions within the next several months as part of a multi-year hiring effort. The new employees will be medical officers, consumer safety officers, health care and regulatory scientists, and other such professionals involved in protecting the public from unsafe food and drug products. And I said, “Great! FDA is finally stepping up to its charter and working to provide the manpower demanded for a truly effective safety monitoring and inspection program.”

I read on. It turns out that many of these positions will be located in the Washington metropolitan area, specifically Rockville, Silver Spring, and College Park, MD. That’s logical since that’s where FDA is largely based. And there will also be new hirings across the country in FDA’s five regions, 20 districts, more than 179 resident posts, and the newly created FDA offices overseas.

And I stopped. What was that? “???. newly-created FDA offices overseas?” What’s that all about? Of course we all know that FDA conducts liaison activities with the safety monitoring agencies of other nations, but that has been in existence for years. Why are new offices suddenly now needed overseas?

Well, it turns out the answer, or at least an attempt at an answer, can be found in FDA’s testimony to Congress, also this week. Entitled, “Restoring FDA’s Ability to Keep America’s Families Safe,” Center for Drug Evaluation and Research (CDER) director Janet Woodcock testified that FDA is no longer “configured to regulate this century’s globalized pharmaceutical manufacturing industry.” And what she means by this is that since, over the last 15 years, our once largely domestic pharmaceutical manufacturing industry has moved almost entirely offshore, if the government agency responsible for monitoring it is to do its job, it has to move offshore as well.

You see, when the drug supply was produced domestically and also monitored and regulated domestically we had safe products, but now that it’s not, we don’t. FDA says it needs more inspectors, more overseas locations, and more modern IT systems to deal with the ever-growing amount of overseas production. The Government Accountability Office (GAO) estimates that it will cost roughly $70 million per year for FDA to inspect all overseas facilities every two years, $16 million to $17 million of which would be required for sites based in China alone.

Well, I don’t know about you, but I find this situation just a tiny bit ironic??? After the government bends over backwards for decades to encourage U.S. industry to move out of the country, taking with it U.S. jobs and GDP, and driving up the national debt to unfathomable levels??? After it has reduced the quality of life and opportunity of all but the wealthiest Americans, is it really now happily setting out to further advance the industries of other countries on the backs of every U.S. taxpayer? I’m afraid so, folks. “If you want us to make sure you have safe drug products, we’re gonna have to go to where they’re made, and that ain’t here.”

Well, I say no way. I say if you want to sell a drug product in this country, you make it here and have its safety and efficacy monitored and regulated here by our domestic federal agency. Or you pay 100% of the cost of hiring and maintaining U.S. government inspectors at your overseas location(s) and those of your suppliers as well. Whichever works out better for you. Am I wrong here, people?

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John Haystead,
Publisher & Editor