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
On June 14, House Energy and Commerce Committee (E&C) Chair Cathy McMorris Rodgers published a “framework for discussion” proposing reforms to the National Institutes of Health (NIH)....more
Attorney Peter Zeidenberg was surprised to learn that NIH had successfully clawed back $3.6 million—plus a nearly 100% penalty—from Cleveland Clinic. The Department of Justice (DOJ) claimed the award funds were ill-gotten...more
The Situation: The National Institutes of Health ("NIH") proposed a new policy requiring entities that receive licenses from the NIH to certain taxpayer-funded inventions to submit Access Plans for ensuring broader patient...more
Some funding applications submitted to NIH beginning Jan. 25 will face new requirements and undergo a revised peer review process. To prepare investigators and institutions, NIH launched a dedicated website with details about...more
On March 20, 2024, The USPTO issued an alert, notifying practitioners that the USPTO had developed training materials for patent examiners regarding searching for prior art in FDA and NIH databases. ...more
Rare Disease Day took place on February 29, 2024. Created in 2008, Rare Disease Day is observed on the “rarest day of the year”—February 29 in leap years (February 28 in non-leap years)—as a way to galvanize the global rare...more
The Food and Drug Administration (FDA) is seeking strategies from Jeffrey W. Taub, M.D., to prevent future violations of human subject regulations the agency said were documented during site visits in September and October...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
CONGRESS - Senate Finance Committee Holds Markup on Better Mental Health Care, Lower-Cost Drugs, and Extenders Act. The bipartisan package includes Medicare and Medicaid extenders, provisions to expand the mental health...more
CONGRESS - House Republicans Elect New Speaker. After weeks of turmoil, the House elected Rep. Mike Johnson (R-LA) as the new Speaker of the House on Wednesday with 220 votes secured on the floor. The House is now able to...more
The House of Representatives has now been without a speaker for 20 days. Last week, Rep. Jordan (R-OH) dropped out of the speaker race after an internal Republican Conference vote showed he had no path to victory. This week,...more
CONGRESS - House Republicans Still Unable to Elect New Speaker. As of publication of this newsletter, the House has held three roll call votes this week to elect a new speaker, with Rep. Jordan (R-OH) failing all three...more
At some point in the future, NIH may halt funding for clinical trials deemed too underpowered to produce meaningful findings or that fail to meet enrollment goals. To do this, the agency would have to adopt so-called...more
During this session, investors and business leaders discussed the future of women-focused care and the exciting opportunities in the rapidly growing sector of women/women+ health....more
Many companies may be quick to dismiss Washington’s “My Health, My Data” (MHMD) as a health data law that does not apply to them. But there are many reasons you should think twice before disregarding this law....more
As the COVID-19 pandemic continues across the United States, states, payers, and providers are looking for ways to expand access to telehealth services. Telehealth is an essential tool in ensuring patients are able to access...more
LEGISLATION, REGULATIONS & STANDARDS - Former FDA Commissioners, Industry Groups Show Support for Modernized FDA Regulatory Framework - In recent months, two former U.S. Food and Drug Administration (FDA) commissioners and...more
The Council on Governmental Relations (COGR) is sounding an alarm regarding costs institutions have expended to comply with “new and clarified provisions calling for researchers to disclose all sources of research support and...more
NIH is unable to “ensure grants have appropriate cybersecurity provisions” and should make nearly a half-dozen changes, according to auditors for the HHS Office of Inspector General (OIG). Yet, NIH said it had already made...more
The National Institutes of Health (NIH) requires recipient institutions—i.e., any entity receiving funding from the NIH—to have policies that foster a harassment-free environment. Recipient institutions are required to...more
President Biden submitted his Fiscal Year (FY) 2023 budget request to Congress on March 28, 2022. The budget request is not binding on Congress. Rather, it may serve as a guide for both Congress and the administration as they...more
Moderna has been engaged in a patent dispute with the National Institutes of Health (NIH) over whether three NIH scientists should be named as inventors for discovering the genetic sequence that’s central to the vaccine. ...more
In a request for information issued on January 5, 2022, the White House Office of Science and Technology Policy (OSTP) announced that it is seeking input from stakeholders across the healthcare spectrum on how digital health...more