But any sweeping improvements will come too late to ensure that neonates like Atticus receive the nutrients that are the foundation for a healthy life. Parents of kids on PN, tired of Congress’s ignoring their pleas and the FDA’s bland form-letter responses, are desperate for a call to action. Where are the innovators? Where is the urgency?
Following the anthrax attacks in October 2001, the US quickly mobilized to expand the national stockpile of anthrax and smallpox vaccines. Now the CDC’s Strategic National Stockpile (SNS) includes antibiotics, chemical antidotes, antitoxins, life-support medications, IV fluids and administration kits, and enough vials of smallpox vaccine to vaccinate every American. According to CDC documents, federal officials can deploy SNS resources even in the instance of a single case of smallpox.
Could the SNS be expanded to include critical drugs and nutrients so the country has a backup when those drugs go into shortage? Federal officials say the SNS is only for public-health emergencies of national-security interest. But the stockpile already contains a form of zinc and calcium: pentetate calcium trisodium injection and pentetate zinc trisodium injection, which bind with plutonium, americium, and curium to speed elimination from the body after radioactive contamination.
Another idea: Why can’t the FDA or the Department of Health and Human Services subsidize manufacturers of generic injectables? There’s precedent. In 2009, HHS paid at least $151 million to a pharmaceutical company for millions of doses of the H1N1 flu vaccine. The same year, the government paid two other pharmaceutical companies $700 million for the swine-flu vaccine.
The FDA Safety and Innovation Act includes incentives for manufacturers to develop drugs to treat MRSA and other antibiotic-resistant pathogens as well as so-called orphan drugs, for diseases that affect a small number of patients.
At some facilities, FDA found mold on the walls, open containers of urine, and metal chips in vials.
Health advocates say congressional action is necessary to help babies who need IV nutrients now. In early May, Senator Al Franken sent a letter signed by 13 bipartisan colleagues to FDA commissioner Margaret Hamburg asking her to “do everything in your power” to fix the nutrient shortage.
Many doctors are pinning their immediate hopes on Congress’s forcing the FDA to form a global pipeline to import an emergency supply. “I have friends in other countries who could get me some, but that would be illegal,” one doctor says. In fact, pharmacists note that the phosphorous Europe uses is a better product than that in the US because it’s organic and doesn’t interact with calcium in the PN, meaning more phosphorous could be included in the IV bag.
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When Miguel Sáenz de Pipaón, a neonatologist at a prominent hospital in Madrid, arrived in the US for a research visit, he was stunned by the nutrition shortages.
“It’s crazy,” he says. “That doesn’t happen in Europe.” He noted that the US relies on a 25-year-old lipid emulsion, which is in shortage, while European hospitals use a newer version that’s readily available. Rather than import the newer emulsion, the US has left many patients without any lipids at all.
The only shortage Sáenz de Pipaón could recall in Spain occurred two years ago when a Canadian factory stopped making trace elements. His hospital pharmacy immediately secured the product from a Swedish manufacturer and had it for patients within two days.
Hospital staff wonder why the FDA hasn’t already put a process in place to streamline foreign inspections and certifications so that labs abroad can manufacture emergency supplies on short notice.
Jensen says the FDA is working on it and that imported nutrients will be shipped soon: “It took a long time to find companies willing to do it, mainly because they couldn’t meet US needs and didn’t have the ability to ramp up for the US. The good news is we’ve got different firms willing to do this for phosphates, zinc, and trace elements. We moved as quickly as we could.”
An FDA spokesman says officials began looking into importation after American Regent’s 2012 shutdown. But that company’s recalls began in 2010, and it first suspended manufacturing operations for more than a month in 2011.
The FDA must have been aware of problems because regulators sent American Regent a warning letter in September 2011. Moreover, the FDA allowed the company to release vials of potassium phosphate contaminated by particulate along with a filter in 2011. Knowing that American Regent produced more than half a dozen nutrients critical to neonatal health, couldn’t the FDA have searched for importation possibilities back then, secured a backup manufacturer, and avoided the current shortages?
Instead, parents are desperately checking the FDA’s drug-shortage site to learn when their babies might finally get the nutrients they need—but the posted availability dates keep slipping ever farther away. For example, on January 16, 2013, the website listed the update for potassium phosphate from Hospira as “Next delivery end January. Estimated recovery 1Q [first quarter] 2013.” On January 27: “Next delivery end February Estimated recovery 2Q 2013.” On March 7, “Next delivery late March. Estimated recovery 2Q 2013.” On May 9, “Next delivery May. Estimated recovery July.”
“The FDA has repeatedly told us that the shortages are short-term and that they don’t need to import yet,” says neonatologist Steve Abrams of Texas Children’s Hospital. “There’s been a general sense that this problem will go away if we just wait until next Tuesday, and next Tuesday just hasn’t come for the last 2½ years.
“This is the first time in over 30 years of practicing medicine I’ve ever not been able to give babies the IV nutrition they require. I don’t think the FDA has done all they could in this regard. Why is this going on for so long with no end in sight?”
Alexandra Robbins is the author of six books. This article was supported by the Fund for Investigative Journalism. Editorial intern Emily Thompson contributed reporting to this article.