The shortage of baby formula in the United States has sparked outrage with the administration of US President Joe Biden and, particularly, with the Food and Drug Administration (FDA) , which closed a large factory recently. In turn, the American population wants to buy high-quality infant formula, as they expect all other FDA-regulated products to be.
Ironically, it is likely that contamination and other control failures are much more common with other FDA-regulated products that come from abroad than with those that triggered the agency’s actions at home, but we just don’t know anything about them. That’s because no one — including the FDA — is making any effort to test products from other countries before they reach the American consumer.
This was not always the case. Less than two decades ago, North America and Europe reliably manufactured virtually all FDA-regulated products, including generic drugs. But then the dynamics of the health products economy changed. As with many other consumer items, first India and then China undermined American pharmaceutical manufacturing, offering low-cost labor and manufacturing with the added benefit of an almost total absence of FDA oversight.
Let’s take an example: in 2004, the last factory in the United States to produce the main ingredients of penicillin was closed, transferring production to abroad to save costs and work in a less FDA-regulated environment. It is inconceivable that the United States can no longer independently manufacture its own penicillin. Let’s hope the same isn’t true for infant formula.
Abbott, the largest manufacturer of infant formula in the US, has cooperated with the FDA and the Centers for Disease Control and Prevention ( CDC) in conducting a full investigation. All investigating parties concluded that none of the products that were contaminated with bacteria were produced at Abbott’s facilities.
In a long series of eleven tweets, the American manufacturer states that: “a comprehensive investigation from Abbott, FDA and CDC found no evidence that our formulas caused childhood illness.” Despite these conclusive findings, the company still remains closed by order of the FDA.
Abbott appears to be another victim of the agency’s disproportionate targeting of the few remaining domestic manufacturers of regulated products. Since the Covid-pandemic 19, the FDA has not fully resumed inspections of drug factories in China and India. Instead, the many idle inspectors focused their ire on the few domestic factories. Closing FDA-regulated facilities always seems to happen much faster than reopening them, even if the allegations are unfounded – as Abbott has made abundantly clear.
Uneven Inspection Standards
For decades, the unequal treatment of US facilities in favor of foreign facilities has been evident to regulatory experts. FDA inspected locations in the US can be inspected at any time and for any reason, while facilities located abroad are inspected much less frequently, sometimes with up to seven years between routine inspections.
In addition, State Department rules force the FDA to announce official business trips abroad, giving foreign factories a notice of “surprise” inspections and ample time to prepare. Other countries may delay FDA inspectors’ visas for months or years at their discretion or until facilities meet inspection standards.
Even with the advantage of advance notice, Chinese manufacturers and Indians continued to rack up violations of incompetence, negligence, and general disregard for the most basic health standards of US manufacturing and quality control.
Instead of conducting independent testing of these imported drugs, the FDA trust Chinese and Indian manufacturers. Independent reviews have found that drugs manufactured abroad show a pattern of mislabeling, potency inaccuracy and contamination with cancer risk factors in drugs, but due to language and legal barriers, it is difficult to identify who is responsible. In addition, parent companies face little or no consequences.
With this unfair treatment by the FDA, Abbott has an incentive to fire American employees and move its factories abroad, where they will benefit from favorable agency treatment, lower costs and higher margins.
What could be done?
Although the current system is unfair and favors foreign manufacturers, there is a simple solution. The FDA could perform independent quality control checks on all regulated products, foreign and domestic, before they reach pharmacies, ensuring quality compliance. The FDA should also require testing of all regulated items that hit US shelves.
As a senior drug safety advisor to the former FDA commissioner (2019–2004), Stephen Hahn, was a strong advocate of advancing quality control measures, for all FDA regulated products, national and foreign.
In fact, the agency already has a fully equipped team to do this. Specifically, Michael Kopcha, a pharmacist who directs the FDA’s Office of Pharmaceutical Quality, oversees more than 1.19 employees and is responsible for about a dozen facilities. across the country who are now fully capable of performing end-product testing on all FDA-regulated items.
But Kopcha and other FDA career bureaucrats have vehemently fought my implementation efforts of quality tests. To protect the public health of FDA regulated overseas (and domestic) products, the FDA must immediately begin clearance testing on all products before they reach consumers.
If the RTRT plus release test, which is benchmark, had already been implemented, he could have ruled out Abbott’s guilt in the first place and prevented the plant closure from taking place.
Now the president Biden activated the Defense Production Act and instructed the military to import 32 1,000 pounds of formula from other countries — but we don’t know if the FDA has inspected these yet. facilities abroad or whether the FDA has plans to conduct “clearance testing” before products are consumed by American babies.
Even as they welcome the arrival of more formula, Americans are right to worry about your safety. The FDA’s way of working is very outdated and has proven to be politically unfeasible, unreliable, and unsafe. Because of this, American babies cannot get the food they need. What is Biden’s FDA under the leadership of Commissioner Robert Califf going to do about it? Unfortunately, I think we all know the answer to that.
DAVID GORTLER is a pharmacologist, pharmacist, FDA and health policy scholar at ETHICS AND PUBLIC POLICY CENTER in Washington, DC