As we move into the heat of the summer, we can look forward to the annual June deluge of opinions coming from the Supreme Court. Last week, the Court ruled on a pair of combined cases that potentially impacts many of our blog readers in …
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Enforcement
- Supreme Court Makes Quick, Unanimous Work of Seventh Circuit’s Interpretation of False Claims Act Scienter RequirementJune 8th, 2023
- How Soon Until the Kochava Geolocation Case Catches Up to Medical Device Companies?May 10th, 2023
We were listening to a radio interview last week with Lina Khan, the Chair of the Federal Trade Commission (“FTC”). In the interview, Khan spoke about the Commission’s efforts to regulate geolocation data trackers so that they don’t abuse their abilities. The risks she described …
- The FTC Asserts Its Penalty Offense Authority (Again)April 18th, 2023
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 …
- HPM’s John Claud to host webinar for FDANews: “Medical Device Enforcement: Latest Developments from the FDA, DOJ and FTC.”April 13th, 2023
On Thursday, April 20, from 1:30-3:00pm, John Claud of Hyman, Phelps & McNamara, P.C. will present a webinar entitled “Medical Device Enforcement: Latest Developments from the FDA, DOJ and FTC.” John will provide participants with a greater understanding of new guidance implications, as well as recent …
- With Oral Argument in Important False Claims Act Case Fast Approaching, A Reminder of the High StakesMarch 23rd, 2023
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 …
- Not Content to Just Play the Hits, DOJ’s New Corporate Enforcement Policies Bring A Fresh Spin to Corporate EnforcementMarch 10th, 2023
The annual ABA White Collar Crime Institute is a popular venue for prominent Department of Justice officials to make speeches announcing new policies. This year, Deputy Attorney General Lisa Monaco took the stage, and her speech included many of the well-known past hits from the …
- He Slimed Me: FTC Hits GoodRx Over Unauthorized Use of Consumer DataFebruary 21st, 2023
GoodRx is a digital health platform familiar to many, and a prime example of a single player that operates in several different realms of the evolving and growing digital health marketplace. Among its services are prescription drug discounts, telehealth visits, and other health services. The Federal …
- An FDA Inspector’s Knock Will More Likely Be Followed by FDA’s Enforcement HammerJanuary 30th, 2023
A recent analysis of statistics on FDA’s website, prepared for a presentation at a good manufacturing practices (GMP) conference in San Diego next week, shows a dramatic increase in the percentage of FDA drug manufacturing facility inspections that result in an “Official Action Indicated” classification. …
- A (Not So) New Avenue to Challenge Misleading Rx Promotion – NADJanuary 25th, 2023
(Caution: Links in the first paragraph are a wild musical ride. Click at your own risk) For those of you that review Rx ad/promo materials, it’s a familiar scenario: Marketing has come to the Legal Department with significant concerns about competitor activities – consumers are being …
- As the Calendar Turns, Cybersecurity Remains Key Focus of Digital Health EnforcementJanuary 6th, 2023
As we turn into the New Year, we offer a few items of interest in digital and telehealth regulation, enforcement, and compliance that may provide some helpful guideposts for stakeholders. In 2022, the chief regulating entities—FDA, FTC, and DOJ—all continued to forge policies to help bridge …
- Third Circuit Court of Appeals Upends “Intended Loss”December 5th, 2022
Sentencing for defendants convicted in federal court of felony offenses that involve fraud, including violations of the Federal Food, Drug, and Cosmetic Act, may be dramatically reduced based on an opinion issued last week by a panel of the Third Circuit Court of Appeals. The …
- The Relationship Between Outside Counsel Investigations and Quality System Investigations, and What to Do when they ConflictDecember 2nd, 2022
Anne Walsh of Hyman, Phelps & McNamara PC will be presenting on “The Relationship Between Outside Counsel Investigations and Quality System Investigations, and What to Do when they Conflict” as part of the Food and Drug Law Institute’s Enforcement, Litigation, and Compliance Conference on December …
- Second Circuit Decision A Reminder that Alleged FDCA Violations Don’t Always Equal FCA ViolationsDecember 1st, 2022
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 …
- When Refusing a Picture During a Food Inspection Could Prove CostlyOctober 27th, 2022
The question of whether FDA has authority to take pictures during an inspection of a facility has bounced around the food and drug bar for many years. FDA’s view is stated in the agency’s Investigation Operations Manual, and it is one with which a number …
- President Biden Gives the Green Light for Significant Marijuana ReformOctober 10th, 2022
On October 6, President Joe Biden issued a brief but sweeping three-step statement towards reforming Federal marijuana law. The president’s first step was a pardon of all prior federal offenses of simple marijuana possession and a direction to the Attorney General to develop an administrative …