TICKTOCK: USER FEE REAUTHORIZATION TIMELINE SLIPPING — Congress will likely miss its self-imposed goal of sending a bill to reauthorize the FDA user fee programs to President Joe Biden’s desk before August, raising the specter that reduction-in-force notices will have to be sent to thousands of agency employees, people familiar with ongoing negotiations told Prescription Pulse. An agreement to reauthorize the programs — which fund nearly half of the FDA’s annual budget — is still expected to be reached before they expire at the end of the fiscal year. But difficulty pre-conferencing the significant differences between the House-passed bill and the Senate HELP Committee’s package is obstructing quick passage. At issue are major provisions in the Senate deal that aim to overhaul how diagnostic tests, dietary supplements and cosmetics are regulated, which are the subject of ongoing pre-conference negotiations between the two chambers. A House Energy and Commerce Committee Republican aide said it “is becoming more challenging” to renew the user fee programs before August because of “the Senate’s holdups and failure” to pass its bill out of committee before Memorial Day. “Adding major riders that do not have broad bipartisan support would slow this down even more, especially given the strong bipartisan support already received in the House on a bill that did not contain these policies,” the aide said. “The Senate should follow the House’s lead and get this back on track so pink slips aren’t issued.” Democrats are still trying to reach a deal before pink slips are sent out, an outcome that might be avoided because of the agency’s large user fee carryover balances. And in July 2017, former FDA Commissioner Scott Gottlieb deferred sending out layoff notices, citing the “high degree of confidence” that the user fee programs would be reauthorized before they expired. It is unclear whether FDA Commissioner Robert Califf will again delay formally issuing the required 60-day reduction-in-force notices if Congress does not act before early August. “At this time, it would be premature to speculate on the Commissioner’s actions in advance of the September 30 deadline,” FDA spokesperson Lauren-Jei McCarthy wrote in an email. “The user fee programs remain an essential part of FDA’s mission to protect public health and accelerate innovation, therefore making the timely reauthorization of critical importance.” HOUSE APPROPRIATORS ADVANCE HHS BILL AFTER ABORTION FIGHT — The House Appropriations Committee approved $242 billion legislation Thursday on a party-line vote that would fund the Department of Health and Human Services for fiscal 2023 — but without longstanding language banning the use of federal funds to cover abortions. Debate over the so-called Hyde amendment dominated the first two hours of the markup, with Republicans arguing that the provision would eventually need to be added to the bill to win enough Senate votes for HHS funding to be appropriated. The committee adopted an amendment to the bill report urging HHS to ensure abortion medication is “accessible, affordable, covered and convenient for patients, including through access to telehealth.” The report already contained language calling on the department to bolster access to contraceptives.
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