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Regulatory News | 19 April 2016 | By Zachary Brennan
The House Appropriations Committee on Tuesday marked up the FY 2017 spending bill for the US Food and Drug Administration (FDA) and decided not to include an amendment adding $1.9 billion in additional funding requested by President Barack Obama to combat the Zika virus.
Republicans argued that Obama did not provide enough specifics on where the funds will go and they voted against Rep. Nita Lowey’s (D-NY) amendment that would have attached the Administration’s additional Zika funds to the spending bill.
Obama’s request, which was updated Monday night to include $235 million more specific funds to help develop a Zika vaccine, calls for increasing NIH funds from $130 million to $277 million to prepare for Phase II vaccine testing and to increase from $100 million to $188 million in funds for the Biomedical Advanced Research and Development Authority. More than 800 Americans, including 89 pregnant women, in 40 states, three US territories, and Washington, D.C. have contracted the virus.
Rep. Hal Rogers (R-KY), who opposed the additional funding request, called for more “information from bureaucrats" on what the additional funding will support.
Similarly, Rep. Tom Cole (R-OK) said he spoke with Obama on the Zika funding, traveled to Brazil to understand more about the work on the ground and that his hesitancy to provide more money is about “doing this rationally.”
Rep. Debbie Wasserman Schultz (D-FL) compared the House’s inaction on the additional funds to trying to block a leaky dam with a finger, while Rep. Sam Farr (D-CA) called for regular order when Congress responds to emergencies, noting that Ebola funding was granted without preconditions.
The markup of the spending bill did not address other provisions in the spending bill, particularly Congress’ push to force FDA to re-write a generic drug labeling rule expected to be released in July, as well as provisions linked to the House-passed 21st Century Cures legislation that are still making their way through the Senate.
What the markup did address are two provisions linked to FDA’s regulation of premium cigars and electronic cigarettes.
The committee adopted an amendment that would grandfather in some e-cigarettes and bar them from FDA oversight, and the committee rejected an amendment that would clear the bill of language preventing FDA from regulating premium or large cigars.
Cole pointed to UK research finding that e-cigarettes are 95% less harmful than tobacco and offered several anecdotes about people he knew who transitioned away from cigarettes because of e-cigarettes.
Rep. Rosa DeLauro (D-CT) pointed out that e-cigarettes can be flavored to taste like Skittles or Fruit Loops and are targeted at children, and Rep. Jose Serrano (D-NY) reminded the committee of the time when the tobacco industry said smoking does not cause cancer.
On the premium cigar front, Rep. Robert Aderholt (R-AL) said the language in the spending bill to keep such cigars from coming under FDA’s purview is a “common sense solution to regulatory overreach.”
Another DeLauro amendment to remove language from the spending bill that would lessen the regulations for drug compounders was denied. And a separate amendment seeking to strike language from the bill that will bar FDA from finalizing lab-developed test guidance was also rejected.
Full Committee Markup - FY 2017 Agriculture Bill
Tags: e-cigarettes, vaping, Zika funding, FDA appropriations