Hudson speaks at a news conference in 2021. Photo: Al Drago/Bloomberg via Getty Images
Expanding FDA authority to deal with drug shortages has emerged as a major dividing point in PAHPA reauthorization.
Why it matters: The Pandemic and All-Hazards Preparedness Act expires at the end of the fiscal year. The clock is ticking for lawmakers to hash out their differences.
Driving the news: Rep. Anna Eshoo, the House Democrats’ lead on PAHPA, took her name off the discussion draft last Wednesday, she confirmed to Axios.
- She made the decision after her GOP counterparts declined to include a section in the draft related to FDA's authorities. “These things have to be taken care of,” Eshoo said to reporters Tuesday. “The one that really has kind of sent me over the top is the shortage of pediatric oncology drugs.”
- Tuesday’s Energy and Commerce health subcommittee legislative hearing on PAHPA covered some bills aiming to improve the Strategic National Stockpile and medical supply.
- But several bills that would expand the FDA’s authority to regulate the drug supply chain were left out, ranking member Frank Pallone noted at the hearing. Previous authorizations of PAHPA have expanded FDA authority.
Where it stands: Republicans say they’re committed to preventing drug shortages — just not through PAHPA.
- “There are a lot of issues Republicans want to see addressed, like gain of function research, like the politicization of guidance from the CDC during the pandemic,” Rep. Richard Hudson, the GOP House lead on the bill, said outside the hearing room. “There are a lot of really serious issues that need to be addressed. But they're not part of PAHPA.”
- “I'm afraid if we start opening up PAHPA to things that aren't PAHPA, then we start taking on extra weight and the boat’s gonna sink,” Hudson said.
- Hudson said he thinks the House could pass a standalone package on drug shortages in the future. Lawmakers on both sides of the aisle told Axios last week that they want to address the problem.
The other side: Democrats stayed adamant during the hearing that addressing drug shortages is germane to PAHPA.
- “It's in the DNA of PAHPA to address gaps in supply,” Eshoo, who co-sponsored the original legislation in 2006, said in her opening remarks.
- “I’m really begging you to find a bipartisan path forward. That’s how serious these issues are,” she said.
Between the lines: The debate over including drug shortages in PAHPA is part of a bigger fight over whether the legislation should wade into FDA territory.
- Congressional Republicans are skeptical of the agency coming out of the pandemic, and not eager to give FDA any more authority.
What’s next: Eshoo doesn’t want to put her name back on the bill until there’s a guarantee that legislation to address the shortage of oncology drugs will be included in must-pass legislation, she said after the hearing.
