The White House team working on the broader issue of longstanding drug supply breakdowns includes national security, economic and health officials, according to James McKinney, a spokesman for the Food and Drug Administration. Bloomberg reported earlier on the White House involvement.
Officials have been debating possible measures like tax incentives for generic drugmakers and greater transparency around generic drug quality. The current incentives favor drugmakers with the lowest prices, which includes those that might cut corners — leading to disruptive plant shutdowns if the F.D.A. demands a fix. (Some shortages, like those of weight-loss drugs, are the result of sky-high demand, while others have been attributed to overprescribing, including for antibiotics, or a lack of investment in potential alternatives.)
The F.D.A., which employs a team of about 10 people who do the day-to-day work of mitigating and reporting drug shortages, has said it is seeking authority from Congress to get additional information about the drug manufacturing and supply chain.
But the agency has also expressed its concerns to the White House about severe financial strain in the generic drug industry — an economic problem that F.D.A. officials say they are not suited to address.
Dr. Robert Califf, the F.D.A. commissioner, highlighted the agency’s views during recent appearances before Congress, saying officials can only plug so many holes.
“We have got to fix the core economics if we’re going to get this situation fixed,” Dr. Califf told a House panel on May 11.
David Gaugh, the interim chief executive of the Association for Accessible Medicines, which represents generic drugmakers, recalled warning F.D.A. officials in an April meeting that the recent bankruptcy and shutdown of Akorn Pharmaceuticals would likely be followed by others.