Biden Invokes Defense Production Act   05/19 06:20

   President Joe Biden invoked the Defense Production Act to speed production 
of infant formula and authorized flights to import supply from overseas, as he 
faces mounting political pressure over a domestic shortage caused by the 
safety-related closure of the country's largest formula manufacturing plant.

   WASHINGTON (AP) -- President Joe Biden invoked the Defense Production Act to 
speed production of infant formula and authorized flights to import supply from 
overseas, as he faces mounting political pressure over a domestic shortage 
caused by the safety-related closure of the country's largest formula 
manufacturing plant.

   The Defense Production Act order requires suppliers of formula manufacturers 
to fulfill orders from those companies before other customers, in an effort to 
eliminate production bottlenecks. Biden is also authorizing the Defense 
Department to use commercial aircraft to fly formula supplies that meet federal 
standards from overseas to the U.S., in what the White House is calling 
"Operation Fly Formula."

   Supplies of baby formula across the country have been severely curtailed in 
recent weeks after a February recall by Abbott Nutrition exacerbated ongoing 
supply chain disruptions among formula makers, leaving fewer options on store 
shelves and increasingly anxious parents struggling to find nutrition for their 
children.

   "I know parents across the country are worried about finding enough formula 
to feed their babies," Biden said in a video statement released Wednesday by 
the White House. "As a parent and as a grandparent, I know just how stressful 
that is."

   The announcement comes two days after the Food and Drug Administration said 
it was streamlining its review process to make it easier for foreign 
manufacturers to begin shipping more formula into the U.S.

   In a letter Wednesday to the Department of Health and Human Services and the 
Department of Agriculture, Biden directed the agencies to work with the 
Pentagon to identify overseas supply of formula that meets U.S. standards over 
the next week, so that chartered Defense Department flights can swiftly fly it 
to the U.S.

   "Imports of baby formula will serve as a bridge to this ramped-up 
production," Biden wrote.

   Regulators said Monday that they'd reached a deal to allow Abbott Nutrition 
to restart its Sturgis, Michigan, plant, the nation's largest formula plant, 
which has been closed since February due to contamination issues. The company 
must overhaul its safety protocols and procedures before resuming production.

   After getting the FDA's OK, Abbott said it will take eight to ten weeks 
before new products begin arriving in stores. The company didn't set a timeline 
to restart manufacturing.

   "I've directed my team to do everything possible to ensure there's enough 
safe baby formula and that it is quickly reaching families that need it the 
most," Biden said in the statement, calling it "one of my top priorities."

   The White House actions come as the Democratic-led House approved two bills 
Wednesday addressing the baby formula shortage as lawmakers look to show 
progress on what has become a frightening development for many families.

   One bill with wide bipartisan support passed by a vote of 414-9. It would 
give the secretary of the Agriculture Department the ability to issue a narrow 
set of waivers in the event of a supply disruption. The goal is to give 
participants in an assistance program commonly known as WIC the ability to use 
vouchers to purchase formula from any producer rather than be limited to one 
brand that may be unavailable. The WIC program accounts for about half of 
infant formula sales in the U.S.

   "I want to say to the mom struggling that we hear you in Congress and you do 
not need to handle this on your own. We are working to find you a solution," 
said the bill's sponsor, Rep. Jahana Hayes, D-Conn.

   The other measure, a $28 million emergency spending bill to boost resources 
at the Food and Drug Administration, passed by a mostly party-line vote of 
231-192, and it's unclear whether the Senate will go along.

   "This bill just continues the Democrats' strategy of throwing money at the 
same bureaucrats who caused the crisis and who have not made its solution a 
priority," said Rep. Andy Harris, R-Md.

   Rep. Rosa DeLauro, the Democratic chair of the House Appropriations 
Committee, said the money would increase FDA staffing to boost inspections of 
domestic and international suppliers, prevent fraudulent products from getting 
onto store shelves and acquire better data on the marketplace.

   "It is essential that we ensure the federal government has the resources it 
needs to get baby formula back on the shelves," said House Speaker Nancy 
Pelosi, D-Calif.

   Abbott's voluntary recall was triggered by four illnesses reported in babies 
who had consumed powdered formula from its plant. All four infants were 
hospitalized with a rare type of bacterial infection and two died.

   After a six-week inspection, FDA investigators published a list of problems 
in March, including lax safety and sanitary standards and a history of 
bacterial contamination in several parts of the plant. Under Monday's 
agreement, Abbott must regularly consult with an outside safety expert to 
restart and maintain production.

   Chicago-based Abbott has emphasized that its products have not been directly 
linked to the bacterial infections in children. Samples of the bacteria found 
at its plant did not match the strains collected from two babies by federal 
investigators.

   But FDA officials pushed back on that reasoning Monday on a call with 
reporters -- their first time publicly addressing the company's argument. FDA 
staffers noted they were unable to collect bacterial strains from two of the 
four patients, limiting their chances of finding a match.

   "Right from the get-go we were limited in our ability to determine with a 
causal link whether the product was linked to these four cases because we only 
had sequences on two," FDA's food director Susan Mayne said.

   Fixing the violations uncovered at Abbott's plant will take time, according 
to former FDA officials. Companies need to exhaustively clean the facility and 
equipment, retrain staff, repeatedly test and document there is no 
contamination.

   As part of the FDA's new import policy, regulators said companies would need 
to provide documentation of their factory's inspections.