AGG Talks: Antitrust and White-Collar Crime Roundup Podcast - Episode 9: Exploring the DA’s Proof, Michael Cohen’s Cross-Examination, and Jury Scenarios in Trump’s Election Interference Trial
2024 Elections: The Race for the White House and Congress
DE Under 3: Major USDOL Policy Initiatives on Hold Pending Acting Secretary of Labor Julie Su's Confirmation Struggles
Nota Bene Episode 44: Executive Branch Forecast Q3: Mueller’s Testimony, the Fiscal Cliff, and Gerrymandering with Jonathan Meyer
The U.S. House of Representatives Committee on Energy and Commerce's Subcommittee on Health held a recent hearing titled "Made in America: Strengthening Domestic Manufacturing and the Health Care Supply Chain." The hearing...more
Looking Ahead: House to Vote on Compromise Budget Resolution On the heels of the U.S. Senate's passage of a compromise budget resolution, the U.S. House of Representatives is expected to consider the budget resolution on the...more
Holland & Knight Health Dose Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more
Fresenius hiring Ascension Capital exec to head care delivery - The appointment of Craig Cordola as CEO of the dialysis company’s care delivery segment takes effect Jan. 1. He was at Ascension Capital for the past six...more
The House and Senate were both in session this week. The House Ways & Means Health Subcommittee met to discuss policies inhibiting innovation and patient access, and the House Energy & Commerce Health Subcommittee held a...more
Congress was in session, and it was a busy healthcare week at the committee level, with six hearings focused specifically on health issues. On the House floor, Republicans passed the Limit, Save, Grow Act—a bill that raises...more
This week Patrizia Cavazzoni (Director, CDER), Peter Marks (Director, CBER), and Jeffrey Shuren (Director, CDRH) of the FDA testified before the committee on Health Education, Labor and Pensions of the U.S. Senate regarding...more
Consumers have gotten eyebrow-raising views of Big Pharma’s ugly business practices and the tough and sometimes sketchy efforts to rein in the industry’s ravenous pursuit of profits - in settling claims over distributors...more
Drug Pricing Initiatives: Debate continues regarding the drug pricing measures pending in Congress. On June 22, 2021, Senate Finance Committee Chair Ron Wyden released legislative principles that, among other things, would...more
In an exchange which has now gone viral, freshman U.S. Representative Katie Porter (D-Calif.) questioned former Celgene CEO Mark Alles about his 2017 compensation structure last week. Rep. Porter, who is now famous for...more
In response to the United States’ rapidly evolving public health situation, the US Food and Drug Administration (FDA) recently released guidance on high-complexity in vitro diagnostic (IVD) tests for COVID-19. This article...more
Nearly 30 years ago, the first law authorizing the Food and Drug Administration (FDA) to collect fees from drug manufacturers to expedite the review of new prescription drug applications was enacted. Since then, additional...more
When members of the U.S. House of Representatives and Senate were sworn into office in January 2019, Democrats took control of the House and its oversight agenda for the first time in eight years, 235-200 seats, and...more
In This Issue - 1. Drug Manufacturing: Sen. Grassley Pressures Company Over Data Manipulation - 2. Medical Product Innovation: Update to 21st Century Cures Act in the Works - 3. Drug Pricing: Senate Finance...more
Last week the Senate Judiciary Committee held two of three scheduled hearings on “The State of Patent Eligibility in America.” Many witnesses with prominent roles in the patent field testified in favor of legislative action...more
HHS proposes to remove rebates from the Anti-Kickback Statute’s “discount” safe harbor and add new safe harbor for point-of-sale discounts. On January 31, 2019, the Department of Health and Human Services (HHS) announced a...more
Americans should be wary lest they get in between Big Pharma and a buck. That’s what investigators for a U.S. Senate subcommittee showed when scrutinizing how industry middlemen inundated the Show Me State with more than a...more
On Tuesday, May 8th, the House held three hearings related to combating the opioid epidemic. The first hearing came out of the Energy and Commerce (E&C) Subcommittee on Oversight and Investigations, which examined opioid...more
According to an article posted today on the BioCentury website, the Trump administration is drafting an executive order that will take on the high costs of pharmaceuticals by instructing “executive agencies to use value-based...more
As we noted previously in our introductory blog post on the 2017 User Fee Act (UFA) reauthorization process, the first UFA hearing on Capitol Hill was convened on March 2, 2017 by the House Energy & Commerce Committee’s (E&C)...more
The nominee for the top job at the U.S. Food and Drug Administration is being held hostage by Congress until the agency agrees to revamp its approval process for opioid painkillers....more
Some quick updates on stories I have been following: SENTENCING FOR DEADLY PAIN-MEDS DOC: An Orange County, CA., physician has been sentenced to 30 years to life imprisonment. She was convicted of murder for her...more
Congress’s complex relationship with prescription drugs was on display today in the House of Representatives. In the House Committee on Oversight and Government Reform (OGR), Martin Shkreli pleaded the 5th at a hearing...more
This Week: House Energy and Commerce Subcommittee Holds Hearing on Legislation to Strengthen Medicaid Program Integrity and Fraud Controls... Bipartisan Senate Bill Introduced to Stop Anti-Competitive “Pay-For-Delay”...more