- House Democrats have introduced legislation to beef up Food and Drug Administration baby formula inspections in response to the plant closure that triggered a supply shortage.
- The House will hold hearings on the infant formula shortage with FDA Commissioner Robert Califf.
House Democrats will hold hearings on the baby formula shortage in the U.S., and move to pass legislation to increase Food and Drug Administration inspection staff to ensure that imported products are safe for infants to consume.
Rep. Rosa DeLauro, chair of the House Appropriations Committee, introduced legislation on Tuesday that would provide the FDA with $28 million in emergency funding to ramp up inspections at baby formula plants around the world.
The FDA is increasing baby formula imports from other countries to help ease the shortage. It stems in part from the closure of Abbott Nutrition's plant in Sturgis, Michigan, due to bacterial contamination at the facility. The U.S. normally produces 98% of the infant formula that Americans buy, and four manufacturers — Abbott, Mead Johnson Nutrition, Nestle USA and Perrigo — control 90% of the domestic market.
To sell formula in the U.S., foreign companies are required to submit applications to the FDA, which would then review whether their products are safe and nutritious for infants.
However, DeLauro said the FDA told her that it only has nine people to inspect domestic formula plants, along with seven facilities in Europe and two in Mexico. The FDA could eventually have to inspect more plants if it approves additional submissions to sell formula.
"Those facilities have to be inspected. FDA does not have the adequate inspection force to be able to do that and to do it in a timely way," DeLauro, D-Conn., told reporters during a news conference Tuesday. The legislation also includes funding for supply chain monitoring and money to root out fraud, she said.
DeLauro said House Democrats are also considering legislation that would strengthen the FDA's authority to hold companies accountable. The drug regulator does not have the power to order manufacturers to recall unsafe products. It can only recommend a recall when it finds safety issues.
"The FDA has no power to recall. We say recall, but it really is a moral suasion issue," House Speaker Nancy Pelosi, D-Calif., said at the news conference.
A House Appropriations Subcommittee on Agriculture will hold a hearing on Thursday with FDA Commissioner Robert Califf on the infant formula shortage, DeLauro said. The House Energy and Commerce Committee has set another hearing on May 25 with Califf and the FDA's food policy chief, Frank Yiannas, according to Rep. Frank Pallone, the committee chairperson.
Representatives from infant formula manufacturers Abbott, Gerber and Reckitt will also attend next week's hearings, Pallone said.
The Justice Department, in a complaint filed in federal court Monday, alleged that Abbott introduced adulterated infant formula into the consumer market. Four infants who consumed formula made at the Sturgis plant were hospitalized with bacterial infections, two of whom died.
Abbott in a statement Monday maintained there's "no conclusive evidence" to tie the infant illnesses to the company's products.
As Democrats ramp up their efforts to address the crisis, they have also increased their calls for accountability.
"I think there might be a need for an indictment," Pelosi said, without specifying who should face indictment. The speaker's office did not response to requests for clarification.
Abbott and the FDA reached an agreement, subject to federal court enforcement, to reopen the plant after the company brings in outside experts to fix unsanitary conditions at the plant. However, Abbott has said it will take about two weeks to reopen, subject to FDA approval. It could take up to eight weeks for product to arrive in stores.
Abbott is subject to the agreement, called a consent decree, for at least five years. If it does not comply with the decree, the company is subject to $30,000 in damages for every day it's in violation.
Abbott is required to shut down the Sturgis plant again if any product tests positive for Cronobacter sakazakii or Salmonella. It must then dispose of the product, find the contamination source and correct the problem.
Abbott would only be able to restart the plant when it receives clearance from the FDA.