During the Regulatory Freeze Pending Review and the HHS Immediate Pause on Issuing Documents and Public Communications, our thoughts turned to the principles underlying the Freedom of Information Act (FOIA). As the DOJ FOIA Guide explains in its introduction: The United States Supreme Court has explained …
The confirmation hearings for Robert F. Kennedy, Jr. to lead the Department of Health and Human Services kick off at 10 am on January 29 and promise to have a packed agenda. With oversight over FDA, the Centers for Medicare & Medicaid Services, the National …
The word unprecedented has been used a lot in the past two weeks. Perhaps appropriately. Below is some precedent that’s been on this blogger’s mind recently and that may be relevant in the coming days, weeks, and months: Tummino v. Hamburg. Why? The HHS Secretary …
On November 8, 2024, FDA issued a proposed order to remove the oral decongestant ingredient phenylephrine (including both phenylephrine hydrochloride and phenylephrine bitartrate) (collectively, PE) from the OTC monograph on the basis of a lack of effectiveness. FDA also noted that it has concluded that …
Back in July, the United States Supreme Court turned the world of administrative law on its head, adding new layers of judicial oversight to what might have previously been thought of as fairly non-descript Federal agency functions. One of those cases was Loper Bright v. …
It took only 3 months. In June, the Supreme Court ruled that the SEC cannot use its administrative authority to impose civil penalties for securities fraud on the ground that these penalties violate the U.S. Constitution’s Seventh Amendment right to a jury trial. See SEC …
The Supreme Court’s recent decision in Loper Bright v. Raimondo has done away with Chevron deference to federal agencies’ interpretation of ambiguous statutes, including the FDA. The decision commands that federal judges must make their own decisions in suits against FDA, considering—but not deferring to—the …
On Thursday, the 27th of June, the Supreme Court issued its decision in Securities and Exchange Commission v. Jarkesy. The court ruled that the Securities and Exchange Commission (SEC) may not impose fines to penalize securities in its administrative proceedings because that practice violates the …
Among the tools that the government has to enforce the FDC Act is the injunctive power granted by Congress in 21 U.S.C. § 332. That statute provides that courts “shall have jurisdiction, for cause shown, to restrain violations” of the FDC Act. Historically, courts have …
The most recent version of the BIOSECURE Act (the “Act”) was introduced in the U.S. House of Representatives (H.B. 7085) and Senate (S.B. 3558) on January 25, 2024. This proposed legislation should be of interest to any biotechnology companies that want to do business with …
As the calendar turned to 2024, we came across the usual end-of year looks back and projections ahead. Our feed saw a number of rosy forecasts for mergers and acquisitions in FDA-regulated industries. Interest rates may be on the way down, which in turn may …
As readers of the FDA Law Blog know, the FDC Act is a strict liability criminal enforcement statute that can impose criminal misdemeanor penalties on a person without any showing of intent. See some of our prior posts, here, here, and here. If committed with …
On April 13, the Federal Trade Commission (“FTC” or “Commission”) issued a press release that it had sent letters to “almost 700 marketing companies that they could face civil penalties if they can’t back up their product claims.” FTC indicates that the notices were sent to companies …
On April 18, the Supreme Court will hear oral argument in two consolidated cases that present the question of whether a defendant can “knowingly” submit a false claim under the Federal False Claims Act when the alleged falsity is based on an objectively reasonable legal …
Earlier this year, we posted on the still unsettled state of the law regarding whether “FDCA violations may, in certain circumstances, be material to the government’s decision whether to pay for the affected product, and thus relevant in an FCA case.” In particular, we noted …
