When Jerry Menikoff retired at the end of 2022 after leading the HHS Office for Human Research Protections (OHRP) for 14 years, he left behind an agency limping along with 20 employees, less than half of what it needed. For...more
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more
In response to Biden Administration goals regarding increasing pharmaceutical competition and lowering drug prices, the USPTO recently released training provided to the USPTO examining corps on utilizing publicly available...more
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
Under the University and Small Business Patent Procedures Act of 1980 (35 U.S.C. §§ 200-212), commonly referred to as the Bayh-Dole Act, the federal government can exercise “march-in” authority in certain circumstances to...more
In an attempt to rein in rising drug prices, the Biden administration unveiled a proposed framework of factors that federal agencies should consider when choosing whether to exercise so-called “march-in rights.” March-in...more
The Biden Administration recently announced a plan to leverage an old tool in a new way to try to reduce drug costs: exercising “march-in rights” under the Bayh-Dole Act for drugs that were supported by government funding. ...more
Presented as part of its effort to lower what it views as excessive prices for prescription drugs, the Biden administration on December 7, 2023, announced the release of a proposed framework to expand the use of government...more
On December 7, the White House announced “New Actions to Lower Health Care and Prescription Drug Costs by Promoting Competition,” which included “a proposed framework for agencies on the exercise of march-in rights on...more
On June 13, the Biden Administration released its Spring 2023 Unified Agenda of Regulatory and Deregulatory Actions, which announced its plan to propose a rule that would ban the inclusion of formaldehyde and other...more
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
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. This week's topics include: ...more
In late July, the U.S. House of Representatives passed H.R. 8454, the Medical Marijuana and Cannabidiol Research Expansion Act (Research Expansion Act). A similar version of the bill, S. 253, passed the Senate earlier this...more
Key Takeaways: The draft guidance represents the first-ever specific expectation by FDA that sponsors develop a diversity plan for trials. FDA’s recommendations come as part of increasing interest in ensuring clinical...more
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more
The first day of spring is right around the corner and so are deadlines for congressional appropriations requests. This month, lawmakers are racing against the clock to fund the government and President Biden looks to...more
As Congress reconvenes, it faces a packed agenda in a legislative year that will be shortened by the upcoming midterm elections and remains buffeted by the persistent coronavirus pandemic. The list of healthcare priorities is...more
On April 16, 2021, the Department of Health and Human Services (HHS) rescinded actions taken during the Trump administration regarding extramural research funded by the National Institutes of Health (NIH) involving human...more
On 9 April 2021, during a weekly economic briefing, President Biden announced his administration’s intent to establish and fund a new regulatory agency, named the Advanced Research Projects Agency for Health (ARPA-H), which...more
The Biden administration has called for all people at least 18 to be eligible for the COVID-19 vaccine by April 19, 2021. Most states have already done so. A BenefitsPro article cites a 2017 survey from the Society for...more
With a vaccination rate of 49 doses administered per 100 people, the United States has administered a higher number of vaccines than any country in the world. As the federal government looks to keep the vaccine rollout...more