On Wednesday, August 16, the Fifth Circuit Court of Appeals issued a ruling upholding parts of a Texas district court’s decision that would, if it becomes effective, severely limit access to mifepristone, one of two pills...more
On January 3, 2023, FDA released an updated Risk Evaluation and Mitigation Strategy (REMS) for mifepristone. The updated REMS follows a December 2021 FDA announcement that it would eliminate the requirement that mifepristone...more
On January 3, 2023, the U.S. Food and Drug Administration (FDA) modified its risk evaluation and mitigation strategy (REMS) program (“Mifepristone REMS Program”) to provide a process for pharmacies to become certified to...more
On March 18, the Office of Inspector General (OIG) issued a favorable Advisory Opinion No. 21-01 (Opinion) regarding a free drug program sponsored by a pharmaceutical manufacturer of a personalized cell and gene therapy...more
From December 23, 2020 through December 31, 2020, the OIG issued several advisory opinions. The advisory opinions analyzed (1) a program for a pharmaceutical manufacturer to provide financial assistance to certain patients,...more
During the coronavirus (COVID-19) outbreak, FDA guidance allows healthcare providers to prescribe drugs subject to Risk Evaluation and Mitigation Strategies without conducting the required laboratory tests or imaging studies....more
On March 22, the U.S. Food and Drug Administration (FDA) published the guidance “Policy for Certain REMS Requirements During the COVID-19 Public Health Emergency,” in which the agency recognizes that completion of laboratory...more
The Daily Report is a compilation of COVID-19 (coronavirus) news briefs from around the world to help life sciences and health care companies stay current in this challenging time. ...more
In Advisory Opinion 20-02, the Office of Inspector General (OIG) approved certain lodging and travel assistance offered by a pharmaceutical manufacturer to patients being administered a drug manufactured by the pharmaceutical...more
The Office of Inspector General for the U.S. Department of Health and Human Services (OIG) recently issued a favorable Advisory Opinion regarding a proposal by a pharmaceutical manufacturer (Requestor) to provide financial...more
US President Donald Trump signed a pair of appropriations bills into law on December 20, including bipartisan legislation intended to facilitate the development of generic and biosimilar products. The bill, previously known...more
On October 22, 2019, Skadden hosted our Ninth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York, which focused on U.S. enforcement issues companies face throughout the industry. The key...more
Autologous chimeric antigen receptor (CAR) T-cells—which are “living drugs”—are promising, emerging therapeutics in immuno-oncology. One example of these “living drugs” is Kymriah (tisagenlecleucel). The drug, a CD-19...more
On July 9, 2019, the U.S. Food & Drug Administration (FDA) released the final guidance document “Risk Evaluation and Mitigation Strategies: Modifications and Revisions Guidance for Industry,” which provides information...more
Food/Dietary Supplements - FDA Issues Information for Food Producers Affected by Tropical Storm Barry – The FDA encouraged food producers to utilize established FDA guidance on evaluating the safety of flood-affected food...more
Below is Alston & Bird’s Healthcare 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
Food/Dietary Supplements - FDA Revises Advice About Eating Fish While Pregnant – The FDA issued a revised “Advice about Eating Fish for Women Who Are or Might Become Pregnant, Breastfeeding Mothers, and Young Children.”...more
This past December, the U.S. Food and Drug Administration (FDA) issued a biosimilar industry guidance on a variety of topics. Mostly overlooked was a Q&A regarding safety protections in a 351(k) application. The FDA...more
This latest installment of the Health Care Enforcement Quarterly Roundup reflects on trends that persisted in 2018 and those emerging trends that will carry us into 2019 and beyond. Leading off with the US Department of...more
Commissioner Gottlieb Welcomes Furloughed Staff Back to Work - The Food and Drug Administration (FDA) commissioner tweeted, “We’re making plans to welcome back all our employees who’ve been on furlough. I hope to...more
Opioid Education - The U.S. Food and Drug Administration (FDA) crept cautiously closer to curbing the opioid crisis by approving sweeping changes as to how the prescription drugs are labeled. Going forward, such...more
The U.S. Food and Drug Administration (FDA) recently released two draft guidance documents related to its requirement for shared risk evaluation and mitigation strategies (REMS) and the process for requesting a waiver of this...more
We have previously reported on the Risk Evaluation and Mitigation Strategy (REMS) program, its effect on generic development, and the FDA’s guidance on how to prevent brands from using the REMS program to block generic entry....more
For certain drugs with serious risks, the FDA may require drug developers to submit a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of a drug or biologic outweigh its risks. We have previously...more
RYAN SAYS POTENTIAL COMPROMISE COMING ON RISK EVALUATION AND MITIGATION STRATEGY DRUGS - House Speaker Paul Ryan, R-Wis., last week said congressional leaders are trying to hammer out compromise legislation that would make it...more