House Subcommittee Advances Flat FDA Budget
The House Appropriations Subcommittee on Agriculture/FDA has advanced to the full committee an FDA funding bill that provides almost $2.8 billion ($4.473 billion when excluding tobacco user fees) in direct budget authority for fiscal year 2018, which is the same level as FY 2017. In his opening statement, subcommittee chair Robert Aderholt (R-AL) said the members did not accept the Trump Administration’s proposal to double industry-funded user fees. Instead, the budget recognizes the recently negotiated user fee agreement, which will provide an increase of over $490 million over FY 2017 fee levels. He also noted that the bill provides $60 million in new funds for activities related to the 21st Century Cures legislation.
The Alliance for a Stronger FDA applauded the FDA funding plan. “Despite an exceedingly difficult funding environment, the House subcommittee has, in effect, said: FDA performs essential services and cannot fulfill its responsibilities without resources at least as great as the agency had in FY 17,” said Alliance President and National Kidney Foundation vice president for government relations Troy Zimmerman. “A strong FDA — capable of fulfilling its broad mission — is a critical component of our nation’s health and safety.”
Staunch FDA supporter Rep. Rosa DeLauro (D-CT) said during the bill’s mark-up that despite “good things in the bill, it still underfunds critical programs that threaten the health of our citizens. Today FDA is struggling to protect the public health. We continue to add more responsibilities to their plate without increasing funding. We cannot do more with less, we can only do less with less. Given the utmost importance of the regulations under FDA’s purview, we must do more than what this bill provides.
“Not funding FDA,” she continued, “in my view is irresponsible. I am deeply troubled by the drug compounding language included in the report that would weaken and undermine the Drug Quality And Security Act, an already weak provision made weaker by the report language. We cannot afford to lower standards for the compounding industry when the health and safety of American families is at risk... I am concerned that the report maintains language that prevents FDA from finalizing guidance on laboratory-developed tests, which are currently unregulated. We have all heard horror stories about these tests giving false positives, resulting in patients receiving unnecessary treatments and surgeries. Given the movement on precision medicine it is now even more important to finalize this guidance.”