Category: Legislative

Legislative

Data Privacy

Nebraska to Become 17th State to Pass Consumer Data Privacy Law

Nebraska to Become 17th State to Pass Consumer Data Privacy Law

The Nebraska unicameral legislature passed the Nebraska Data Privacy Act (LB 1074) on April 11th which now heads to Nebraska Governor Jim Pillen for signature. Assuming the bill becomes law, Nebraska will become the 17th state to enact consumer data privacy legislation. The Nebraska bill largely tracks the Texas Data Privacy and Security Act with […]

Read more

Data Privacy

Kentucky, Colorado & Maryland Advance State Privacy Laws

Kentucky, Colorado & Maryland Advance State Privacy Laws

On April 4, Governor Andy Beshear signed into law HB 15 becoming the 15th state to enact comprehensive consumer data privacy legislation. The new Kentucky Consumer Data Protection Act (KCDPA) largely tracks the Virginia’s law but without this year’s amendments relating to children’s data. For agencies already complying with other non-California privacy laws, the Kentucky […]

Read more

Data Privacy

New Hampshire Passes 2nd Consumer Data Privacy Bill of 2024

New Hampshire Passes 2nd Consumer Data Privacy Bill of 2024

Just prior to its first-in-the-nation presidential primary this month, the New Hampshire legislature passed SB255 that is expected by signed into law by Governor Christopher Sununu that will make it the second law comprehensive consumer data privacy bill enacted in 2024. The bill’s effective date is January 1, 2025. The New Hampshire legislation largely follows […]

Read more

Legislative

Will Pasteur Act Finally Pass During Lame-duck Session?

Will Pasteur Act Finally Pass During Lame-duck Session?

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

Legislative

Inflation Reduction Act Includes Drug Price Restrictions, but Is Limited in Scope

Inflation Reduction Act Includes Drug Price Restrictions, but Is Limited in Scope

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

Legislative

Could Burr’s New User Fee Bill Lead to Timely Passage of Legislation?

Could Burr’s New User Fee Bill Lead to Timely Passage of Legislation?

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

Legislative

User Fee Legislation Markup Suggests Added FDA Regulatory Authorities

User Fee Legislation Markup Suggests Added FDA Regulatory Authorities

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

Legislative

House Shines Spotlight on Accelerated Approvals, May Tie Legislation to PDUFA

House Shines Spotlight on Accelerated Approvals, May Tie Legislation to PDUFA

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

Legislative

Delays Add Pressure to User Fee Legislative Process

Delays Add Pressure to User Fee Legislative Process

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

Legislative

FDA Shares Drug Review Priorities, Sets Date for Public Meeting

FDA Shares Drug Review Priorities, Sets Date for Public Meeting

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 […]

Read more