Eshoo, Lance Reintroduce Bill Exempting FDA User Fees from Sequestration

Press Release

A bipartisan duo of House Members reintroduced today the FDA Safety Over Sequestration Act, or FDA SOS Act, which exempts Food and Drug Administration (FDA) user fees from sequestration. FDA user fees are 100 percent industry-financed and are used specifically for the approval of safe and effective drugs and devices. In the event of another sequester like the budget sequestration of 2013, the FDA could lose tens of millions of dollars, preventing it from meeting its Congressionally-mandated responsibilities and leaving patients without lifesaving therapies.

The authors of the bill, Reps. Anna G. Eshoo (D-Calif.) and Leonard Lance (R-N.J.), have concerns that a repeat of the 2013 sequester could reduce not only the FDA's budget from Congress, but also reduce industry-financed user fees to the agency. While manufacturers were paying the full cost of the user fees (as mandated by statute), a significant portion of those funds were not distributed to the agency. After formal requests to Congressional appropriators from Eshoo and Lance, the funds were ultimately restored to the agency, but not without detrimental short and long-term effects. Another sequester could have compounding and devastating effects on patient safety.

"The FDA's user fees are 100 percent private sector dollars," said Eshoo, who serves as a senior member on the Energy and Commerce Committee. "If the intent of sequestration is to limit public spending, withholding private monies is counterintuitive. Whether one agrees or disagrees with sequestration, private dollars should not be held hostage by the policy. It discourages investment in medical innovation and denies patients access to timely and potentially lifesaving therapies."

"Passage of this important bipartisan legislation is vital to protecting the FDA's access to industry user fees. These resources will help ensure that millions of Americans will continue to benefit from medicines and medical devices that are safe and effective," said Lance, a member of the Energy and Commerce Committee's Subcommittee on Health. "Too many life-saving innovations and therapies are needlessly compromised by the short-sighted decision to sequester these funds."

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