House Democrats hold hearings, introduce laws

House Democrats will hold hearings on the US infant formula shortage and will lobby for passage of legislation to increase the Food and Drug Administration’s inspection staff to ensure imported products are safe for infants to consume.

Rep. Rosa DeLauro, chair of the House Appropriations Committee, on Tuesday introduced legislation that would provide the FDA with $28 million in emergency funding to speed up inspections at baby formula factories around the world.

The FDA is increasing imports of baby food from other countries to alleviate the shortage. This is due in part to the closure of Abbott Nutrition’s Sturgis, Michigan facility due to bacterial contamination at the facility. The US typically produces 98% of the infant formula Americans buy, and four manufacturers – Abbott, Mead Johnson Nutrition, Nestle USA and Perrigo – control 90% of the domestic market.

To sell formula in the US, foreign companies must submit applications to the FDA, which then reviews whether their products are safe and nutritious for infants.

However, DeLauro said the FDA told her it had just nine people to inspect domestic formula factories, along with seven facilities in Europe and two in Mexico. The FDA may eventually have to inspect more facilities if it approves additional filings for formula sales.

“These facilities need to be inspected. The FDA doesn’t have the adequate inspection force to do this and to do this in a timely manner,” DeLauro, D-Conn., told reporters during a Tuesday news briefing. The legislation also includes funding for supply chain surveillance and money to fight fraud, she said.

DeLauro said House Democrats are also considering legislation that would strengthen the FDA’s authority to hold companies accountable. The drug agency does not have the power to order manufacturers to recall unsafe products. It can only recommend a callback if it finds security issues.

“The FDA has no authority to recall. We say recall, but it’s really a matter of moral ethics,” House Speaker Nancy Pelosi, D-Calif., said at the news conference.

A House Appropriations Subcommittee on Agriculture will hold a hearing Thursday with FDA Commissioner Robert Califf on the infant formula shortage, DeLauro said. The House Energy and Trade Committee has scheduled another hearing with Califf and FDA food policy director Frank Yiannas for May 25, according to committee chairman Rep. Frank Pallone.

Representatives from infant formula makers Abbott, Gerber and Reckitt will also attend hearings next week, Pallone said.

The Justice Department alleged in a complaint filed Monday in federal court that Abbott placed adulterated infant formula in the convenience market. Four infants who ate infant formula made at the Sturgis plant were hospitalized with bacterial infections, two of whom died.

Abbott claimed in a statement Monday there was “no conclusive evidence” to link the teething illnesses to the company’s products.

As Democrats intensify their efforts to deal with the crisis, they have also stepped up their calls for accountability.

“I think an indictment might be needed,” Pelosi said, without specifying who should be indicted. The spokesman’s office did not respond to requests for clarification.

Abbott and the FDA reached an agreement, subject to enforcement by federal courts, to reopen the facility after the company called in outside experts to address unsanitary conditions at the facility. However, Abbott has said it will take about two weeks to reopen, pending FDA approval. It can take up to eight weeks for the product to arrive in stores.

Abbott is subject to the agreement, known as the Consent Decree, for a minimum of five years. If it fails to comply with the decree, the company must pay $30,000 in damages for each day it violates.

Abbott has to close the Sturgis plant again if a product tests positive for Cronobacter sakazakii or Salmonella. He then has to dispose of the product, find the source of the contamination and fix the problem.

Abbott might not restart the facility until it receives FDA approval.