Tag: Jon Bigelow

Jon Bigelow

Washington Focus

Pressure Mounting for FDA Commissioner Among Reports that Califf Will Be Biden’s Choice

Pressure Mounting for FDA Commissioner Among Reports that Califf Will Be Biden’s Choice

Oct. 21, 2021—Nine months into President Joe Biden’s administration, he has still not nominated a candidate to take the helm at the Food and Drug Administration (FDA). Amid the COVID-19 pandemic and other pressing healthcare issues, the pressure is rising for a permanent FDA commissioner, but many of the frequently-named frontrunners for the position appear […]

Read more

Regulatory/FDA

FDA Issues BsUFA Commitment Letter, to Hold Public Meeting Nov. 2

FDA Issues BsUFA Commitment Letter, to Hold Public Meeting Nov. 2

Oct. 11, 2021 – The Food and Drug Administration (FDA) will hold a virtual public meeting Nov. 2 to discuss the proposed changes it would like to make during the reauthorization process for the Biosimilar User Fee Act for fiscal years 2023 through 2027 (BsUFA III). The current legislation, BsUFA II, will expire in September […]

Read more

Regulatory/FDA

FDA, HRA Starting to Address Trial Investigator Result Reporting Lapses

FDA, HRA Starting to Address Trial Investigator Result Reporting Lapses

Sept. 27, 2021 – In the midst of public scrutiny regarding clinical trial transparency, the Food and Drug Administration (FDA) and the United Kingdom’s Health Research Agency (HRA) recently took actions that may indicate their increased willingness to more closely monitor clinical investigators who do not report trial results in a timely manner. “Pharma, researchers, […]

Read more

Regulatory/FDA

BMJ Study: Accelerated Approval Drugs Retain Status Despite Lack of Benefit

BMJ Study: Accelerated Approval Drugs Retain Status Despite Lack of Benefit

Sept. 20, 2021 – Six out of 18 cancer drugs that initially received accelerated approval from the FDA have indications that remain on the labeling and continue to be recommended in clinical guidelines despite post-approval trials demonstrating no improvement in the primary endpoint, according to a retrospective observational study published Sept. 9 by BMJ. “The […]

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

Legislative

What Biden’s Drug Pricing Plans Could Mean for Biopharma

What Biden’s Drug Pricing Plans Could Mean for Biopharma

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

Data Privacy

Colorado Is Third State to Enact Data Privacy Law

Colorado Is Third State to Enact Data Privacy Law

July 19, 2021 – Colorado became the third state to enact comprehensive data privacy legislation – after California and Virginia – when Gov. Jared Polis (D) signed the Colorado Privacy Act into law on July 8. The Colorado law is similar to the two other states’ laws, in that it grants individuals greater control over […]

Read more

Regulatory/FDA

CDER Approves 27 Novel Drugs in First Half of 2021

CDER Approves 27 Novel Drugs in First Half of 2021

July 12, 2021 – The COVID-19 pandemic did not slow down the drug approval process for the FDA’s Center for Drug Evaluation and Research (CDER) in 2020 – a year that saw CDER approve the second-highest number of new molecular entities (NMEs) – and that pace seems to be holding steady in 2021, with CDER […]

Read more

Legislative

21st Century Cures 2.0 Seeks to Formalize Plans for ARPA-H

21st Century Cures 2.0 Seeks to Formalize Plans for ARPA-H

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 […]

Read more

DTC Advertising

“List Prices in DTC Ads” Proposal Reintroduced After Aduhelm Pricing Decision

“List Prices in DTC Ads” Proposal Reintroduced After Aduhelm Pricing Decision

June 29, 2021 – In the wake of the FDA granting a controversial accelerated approval for Biogen’s aducanumab (Aduhelm) – and Biogen’s decision to set the list price for the drug for Alzheimer’s disease at $56,000 per year despite equivocal evidence of efficacy – members of Congress are introducing drug pricing legislation, calling for hearings, […]

Read more