House committee sends FDA budget to floor vote

Regulatory NewsRegulatory News | 23 June 2022 |  By 

The US House Appropriations Committee has sent the Food and Drug Administration’s FY2023 funding bill to the full House for a vote. It includes an amendment to stop Russian drugmakers from selling their products in the US to protest the war in Ukraine.
On 23 June, the House Appropriations Committee voted 31 to 26, down party lines, to forward a $27.2 billion agriculture budget bill which includes $3.66 billion for FDA in FY2023. (RELATED: House subcommittee moves FDA $3.6B budget forward, Regulatory Focus 15 June 2022)
“Within this total, there are several important investments, including increases to address the opioid crisis, and for ALS clinical trials, unannounced inspections of foreign drug manufacturing facilities, the safety of infant formula, and the Office of Minority Health,” agriculture subcommittee Chair Sanford Bishop (D-GA) noted.
During the budget hearing, Rep. Ken Calvert (R-CA) proposed an amendment that prohibits FDA from using the funding to review or approve premarket drug applications filed by Russian pharmaceutical companies. The amendment does however make an exception for novel drugs and those meant to address unmet needs.
“It's been reported that Russian pharmaceutical companies are seeking FDA approvals to access the US market," said Calvert. “There's no reason we should be providing Russian companies with new market access to our country.”
“The world has always benefitted when the United States chooses to lead and we must continue to stand for democracy and do everything we can to pressure the Russian regime to end its barbaric assault on Ukraine," he added.
Rep. Andy Harris (R-MD), agriculture subcommittee ranking member, supported the amendment noting the US already had a slew of sanctions levied against Russia due to its invasion of Ukraine.
“However, health companies, drugmakers, medical devices and health care equipment companies have largely been exempt from these sanctions,” he said. “This carefully worded amendment targets Russia's sophisticated home-grown pharma sector.”
Harris also added that the US should not depend on Russian medical products especially as it is trying to onshore manufacturing of such products in the US after facing supply chain challenges during the COVID-19 pandemic.
Democrats, including Bishop, also supported the amendment. He and Committee Chair Rep. Rosa DeLauro (D-CT) however said they would like to continue working on the language of the amendment to avoid any unintended consequences. DeLauro noted that FDA does not track geographic location of drugs so implementing the amendment may be difficult.
Ultimately the amendment passed unanimously by voice vote.
Another topic that members on both sides of the aisle agreed on was that there were several failures by both regulators and industry that led to the current infant formula shortage. While lawmakers have repeatedly grilled FDA officials, including Commissioner Robert Califf, on the issue, many of them are unsatisfied with the agency’s response to investigate the issue and take actions to prevent a similar crisis in the future.
Rep. Jaime Herrera Beutler (R-WA) proposed an amendment to withhold 30% of the funding from the FDA ommissioner’s office until the agency provides details on the leadership failures leading up to the infant formula shortage and how the agency plans to correct its operations.
The shortage began under the leadership of former FDA Acting Commissioner Janet Woodcock, who many lawmakers have blamed for the crisis. So far, at least three infant deaths have been associated with formula produced by Abbott Nutrition’s Sturgis, MI facility.
Harris supported the amendment and noted that it would put a timeline on FDA to respond to the committee’s demand for answers by next summer when the agency would potentially face a budget shortfall if it doesn’t report back to Congress.
"That's all this amendment does, it asks for a report,” he said. “Oh my god, we ask for reports all the time. Again, the fiscal year doesn't start until October 1, and that withhold doesn't go into effect until next summer.”
Democrats, however, argued that the amendment would instead hamstring the agency and exacerbate the crisis by potentially forcing FDA to cut inspections.
DeLauro said the committee also needs to look at how market consolidation of infant formula has led to the current crisis and continued to advocate for a separate agency that specifically addresses food safety, or at minimum hiring a deputy commissioner for food safety. She also said that rather than getting FDA’s take on what happened, she wants to see a report from the Department of Health and Human Services (HHS) Office of Inspector General (OIG) on the matter. (RELATED: Califf uses budget hearing to advocate for resources, authority to monitor supply chains, Regulatory Focus 19 May 2022)
"I think the better answer is to get a third party who is above the fray who can give us the actual information and then let the chips fall where they may," said DeLauro.
"I don't disagree with what you're saying with regard to an [inspector general] investigation but we can't only look back,” said Herrera Beutler. “Yes, we need to figure out what went wrong but we also need to make sure that they have taken responsibility to change their actions and they're hiding, Ms. Woodcock is hiding from us."
The amendment ultimately failed with overwhelming opposition from Democrats.


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