Nov. 14, 2022 – The public health landscape has changed dramatically since the Pioneering Antimicrobial Subscriptions to End Upsurging Resistance Act (Pasteur Act) – a bill that would address the significant and growing problem of antibiotic, antifungal and antiviral resistance – was introduced three years ago and every year since, but despite the ongoing need […]
Read more Aug. 15, 2022 — The Inflation Reduction Act passed last week may represent the best outcome the biopharma industry reasonably could have hoped for at a time when so many in Congress are eager to respond to strong public opinion that prescription prices are too high. The new legislation, which reins in some drug costs […]
Read more July 18, 2022 – With just days left before a deadline to send layoff notices to thousands of Food and Drug Administration (FDA) staff, legislation to reauthorize prescription drug user fees – which fund half of the FDA’s budget – has not yet been passed. Although Congress is well aware of both the Sept. 30 […]
Read more May 17, 2022 – Considering that the Food and Drug Administration (FDA) receives nearly half of its funding from medical product user fees, the timely reauthorization of user fees before the current iteration expires Sept. 30 is paramount to ensuring smooth product review operations. But this “must-pass” legislation opens the door to additional priorities and […]
Read more March 21, 2022 – Pros and cons of the FDA’s accelerated approval pathway took center stage at a House Energy and Commerce Committee meeting held last week. While a slate of health-related bills for possible inclusion in the Prescription Drug User Fee Act (PDUFA VII) reauthorization package were discussed, the hearing led off with arguments […]
Read more Feb. 14, 2022 – Negotiations for prescription drug and medical device user fee legislation are running behind schedule and legislators are concerned about the timeline for the Prescription Drug User Fee Amendments VII (PDUFA VII), the Medical Device User Fee Amendments (MDUFA) and other user fee bills. Because the Food and Drug Administration (FDA) receives […]
Read more Sept. 10, 2021 – The Food and Drug Administration (FDA) recently issued a commitment letter regarding the next iteration of the Prescription Drug User Fee Act (PDUFA VII) that spells out its review timeframes, performance goals and modernization priorities for fiscal years (FYs) 2023-2027. Among these priorities are enhancements related to expediting drug development, expanding decision […]
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Aug. 16, 2021 – As part of his “Build Back Better” agenda, President Joe Biden re-emphasized in a televised address last week that he would like Congress to make changes that would allow Medicare to negotiate drug prices to reduce costs for “millions of Americans.” Specifically, Biden wants to see legislative reforms that would remove […]
Read more July 6, 2021 – The authors of the 21st Century Cures Act, which passed with bipartisan support in 2015, now want to build on its success with new legislation that would improve clinical trials, provide information and training for patients and caregivers, and fund President Joe Biden’s concept for an Advanced Research Projects Agency for […]
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Feb. 15, 2021 – The Maryland House and Senate voted last week to override Gov. Larry Hogan’s May 2020 veto and enact the nation’s first tax on digital advertising, a move that other states are in the process of considering in light of a backlash against big tech companies and significant budget shortfalls as the […]
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