Published May 27, 2022
Although the Biden administration likes to repeat that they are the “adults” back in charge, they regularly attempt to cover up their many failures by blaming others. Joe Biden gave a fantastic and contemplative inauguration speech about “unifying our divided nation,” but from Day 1, with every word and deed, Biden has done the opposite. He has brought this country to the lowest point in many decades, on deficit spending, supply chain, economic policy, political animosity, and the rule of law.
It really did start on Day 1, with a rather un-“adult-like” sour grapes firing of every single Trump-era public health official at the Food and Drug Administration (FDA), including those officials monitoring vaccine safety, despite being deep in the throes of a worsening pandemic. The result was an increased number of dead American as pandemic deaths have been immensely worse under Biden’s watch, despite having Trump’s vaccine. Next, Biden waited more than a year to finally replace the officials, and he started by choosing a very unpopular FDA commissioner, an uninspiring non-reformer and Obama-era re-tread, Dr. Robert Califf.
The same Joe Biden that campaigned on his “plan” to end the pandemic, later admitting he actually never had any “plan,” now wants to let Americans know that he has a different “plan” for the baby formula shortage — which was caused by Califf’s FDA incorrectly blaming Abbott for infant deaths and shutting down its facility in the first place, without consideration of the ramifications.
About 75 percent of U.S. parents and caregivers rely on baby formula to meet the nutritional needs of infants up to 6 months of age. The shortage has disproportionately impacted low-income families and babies that require specialty formulas.
When news of the shortage broke, the Biden administration’s first recommendation was to tell American parents to “call a doctor” to ask them where to buy formula. As a former professor of pharmacology to medical students at Yale and Georgetown universities, I must have missed the lesson plan memo that instructed future physicians on where to shop for baby formula. On a side note, I can tell you that my physician colleagues are already overwhelmed with non-clinical duties, spending two-thirds of their time on paperwork for medical insurance carriers, and are becoming increasingly burdened with direct patient care responsibilities due to hospital understaffing caused by Covid-19 vaccine mandates. Asking Americans to call their “doctors” as a cover for Biden’s FDA error is thoughtless and wrong.
The Biden administration then deflected to physicians again, saying that panicked mothers should call their pediatricians to ask for free samples and to prescribe alternative formulas. The fact that mothers need to make appointments for their infants and physicians now must break away from their daily patient load and administrative duties due to an FDA-caused mess is the core issue at hand.
Next, the Department of Health and Human Services created a webpage telling Americans to call a “community organizer” via their local “Community Action Agency ” so mothers can beg for formula from their local food bank. But that’s hardly a solution; it just shifts the problem from one mother to a different mother!
Strangely, the webpage makes no mention of calling the government’s own border detention centers to obtain the stockpiles of formula reserved for those illegally crossing the southern border.
It’s a far cry from the Biden we saw running for office who eloquently promised to take responsibility and not shift the blame to others. What a difference an election and two years make!
The vacuum of leadership and multitude of poor advice has led to massive confusion, and people panicking and disgracing themselves by taking advantage of the matter. Some online videos of what appear to be English as a second language “first-generation Americans” unfamiliar with the traditional American way of life and our philosophy of “all being in this together” have taken to hoarding product as “sport,” putatively for online selling at a substantial markup. This behavior is predatory, selfish, and quite un-American.
The Real Responsibility Lies With Biden’s FDA and Commissioner Califf
So what happened? Long story short: no Abbott products were found to be contaminated. That’s not just my opinion — that’s the conclusion of the FDA and CDC following a thorough, months-long determination. Abbott had definite violations in its inspection, but none of them warranted an extended FDA shutdown leading to shortages for American infants.
Even after knowing that, the FDA is seemingly taking forever to allow the plant to re-open. As of this writing, it is still shut down. When pressed for answers at the House Committee hearing on May 19, Califf couldn’t project a date when store shelves would be restocked, admitting it could be months.
Will the commissioner or anyone else from the FDA be held accountable for the crisis of desperate mothers and their hungry babies over the last few months? Here is your answer: On May 19, the House passed a bill to give FDA employees an additional $28,000,000.00 taxpayer-funded pay raise. Although the bill states that funding is also to address the baby formula shortage, the FDA already has a $6.5 billion dollar budget for 2022, $3.6 billion of which was “discretionary spending.”
It is unlikely that the $28 million was ever needed for anything other than fatter FDA salaries, and especially since the exact breakdown of baby formula vigilance versus pay raises isn’t specified, it is safe to assume that majority of it will go to salaries. In other words, congressional Democrats alone have decided to reward the lackadaisical and incompetent FDA that inappropriately shut down the Abbott facility, which led to the baby formula shortage in the first place.
In the meantime, the shortage in formula has necessitated hospital admissions for infants all over the U.S.
Rep. Diana DeGette, D-Colo., chairwoman of the House Energy and Commerce Oversight and Investigations Subcommittee, who had previously gushed at the Biden-Harris inauguration, really said it all when she referred to the baby formula shortage as “unacceptable, and worse, totally preventable,” further going on to tell the FDA commissioner that because of it “babies and children are suffering.”
If You Were Abbott, Wouldn’t You Move Overseas Too?
Now formula will be imported from other countries, but as a drug safety expert, I should warn Americans: Unlike Abbott, we don’t know if the FDA has ever inspected those overseas facilities recently — or ever — or if the FDA has any plans for conducting comprehensive “release testing” at any point before the formula is sent off to American infants.
In response to its series of failures, the White House made an obviously staged video of Biden calling companies like Gerber and Reckitt on speakerphone to beg them to ramp up production by overworking their employees to make more formula to cover up for the FDA’s mistakes. Biden appeared to heavily rely on reading notecards. On a side note, all of Biden’s staff wore masks while Biden did not.
The natural business and economic consequences of the ineptitude of the Biden’s FDA is that baby formula manufacturers will be motivated to move their manufacturing facilities from the U.S. to foreign countries, where the FDA won’t be breathing down their necks and able to shut them down based on a whim. If Abbott and companies like it move manufacturing out of country it will result in yet another vacant American manufacturing plant plus lost property, corporate, and salary taxes, while unemployment will need to be paid to those losing their jobs. It’s not just desperate mothers and hungry babies who will lose in this crisis, but all Americans.
Dr. David Gortler is a pharmacologist, pharmacist, and an FDA and health policy fellow at the Ethics and Public Policy Center. He was a professor of pharmacology and biotechnology at the Yale University School of Medicine, where he also served at Yale’s Bioethicist Center, and was an FDA medical officer who was later appointed by the White House as senior advisor to the FDA commissioner for drug safety, FDA science policy, and FDA regulatory affairs. He is a columnist at Forbes, where he writes on drug safety, health care and FDA policy.