The shortage of baby formula in the United States has sparked outrage with the administration of US President Joe Biden and, in particular, with the Food and Drug Administration (FDA). [agência governamental que fiscaliza alimentos e medicamentos nos EUA], 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, contamination and other quality control failures are likely to be 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.
It wasn’t always like that. 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, moving production abroad to save costs and work in an environment less regulated by the FDA. 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, cooperated with the FDA and the Centers for Disease Control and Prevention (CDC) in conducting a thorough 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 by 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-19 pandemic, the FDA has yet to fully resume 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 accusations are unfounded — as Abbott has made abundantly clear.
Uneven inspection standards
For decades, the unequal treatment of US installations in favor of foreign installations has been evident to regulatory experts. FDA-supervised 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 inspector visas for months or years at their discretion or until facilities meet inspection standards.
Even with the advantage of early warning, Chinese and Indian manufacturers continued to pile up violations through incompetence, negligence, and general disregard of the most basic sanitary standards of US manufacturing and quality control.
Rather than independently testing these imported drugs, the FDA relies on 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 few or no consequences.
With this unfair treatment by the FDA, Abbott has an incentive to lay off American employees and move its factories abroad, where they will benefit from the agency’s favorable treatment, lower costs and thicker margins.
What could be done?
While 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 arrive on US shelves.
As Senior Adviser on Drug Safety to former FDA Commissioner (2019–2021), Stephen Hahn, I strongly advocated advancing quality control measures, for all FDA-regulated products, domestic 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 1,300 employees and is responsible for about a dozen facilities across the country that are already fully capable of performing end-product testing on all items. regulated by the FDA.
But Kopcha and other career FDA bureaucrats have vehemently fought my efforts to implement quality testing. To protect the public health of overseas (and domestic) FDA-regulated products, the FDA must immediately begin clearance testing on all products before they reach consumers.
If the benchmark RTRT plus clearance test had already been implemented, it could have ruled out Abbott’s fault in the first place and prevented the plant closure from taking place.
Now, President Biden has enacted the Defense Production Act and instructed the military to import 32,000 pounds of formula from other countries — but we don’t know if the FDA has already inspected these facilities abroad or if the FDA has plans to conduct “skin testing.” release” before the products were consumed by American babies.
Even as they welcome the arrival of more formulas, Americans are right to be concerned about their 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 the ETHICS AND PUBLIC POLICY CENTER in Washington, DC
©2022 National Review. Published with permission. original in English.
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