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A Deep Dive Into the Second Circuit’s Caronia Decision, Potential Next Steps, and Potential Enforcement Fallout
…federal programs were false. The government also has litigated a number of criminal prosecutions of companies and individuals for their alleged off-label promotion. In light of the Second Circuit’s statement…
HP&M Presents the Evolution of FDA and the Park Doctrine
…Justice (“DOJ”), can criminally prosecute food, drug, medical device, and cosmetic company executives and other employees when their company has allegedly violated the Federal Food, Drug, and Cosmetic Act, even…
He Slimed Me: FTC Hits GoodRx Over Unauthorized Use of Consumer Data
…personal health information. Unauthorized disclosures can occur either through external hacks or, as we see here, as part of a digital health company’s own internal policies. FTC and DOJ have…
Change Is In The Winds At DOJ
…resources to representing FDA, both in criminal and civil suits that FDA has wanted filed against persons who have allegedly violated the FDC Act, and in suits where persons have…
HRSA Initiates Rulemaking to Implement Health Reform Changes to the 340B Drug Pricing Program
…Care Act (“PPACA”). We previously blogged about this and other drug- and device-related provisions of PPACA. Among other mandates relating to the 340B Program, PPACA § 7102 requires HHS to…
Outstanding Pre-FDAAA Citizen Petition Causes FDA to Rule Against 180-Day Exclusivity Forfeiture for Generic SKELAXIN
…Inc. v.Eon Labs, Inc., Civil Action No. 04-5540), triggering a 30-month stay of ANDA approval. King also timely sued Sandoz for infringement of the ‘566 patent in the U.S. District…
The FTC Asserts Its Penalty Offense Authority (Again)
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…
Medical Device Recall or Product Enhancement? FDA’s New Draft Guidance Should Be Recalled for Significant Repairs
…device without physical removal from its point of use (id. § 806.2(d)). A removal has the same definition as a correction except there is physical removal of the device from…
Mass. Company Pays Hefty Penalty After Admitting to Violating the FDC Act and to Obstructing an Administrative Proceeding
…Criminal Procedure 11(c)(1)(C), under which the parties can agree to the particular sentence imposed (subject to court approval), Bryan Corporation pled guilty to misdemeanor violations of the federal Food, Drug,…
Guidance on Guidance on Guidance
As one of her final acts before leaving DOJ, Associate Attorney General Rachel Brand announced that DOJ would no longer permit its lawyers to use guidance documents issued by its…
Senate Will Take up Another Dextromethorphan Bill; CSA Scheduling Mandated
…if enacted, would place unfinished dextromethorphan in Schedule V under the CSA. Schedule V substances have a low potential for abuse and have a currently accepted medical use in treatment…
Getting to the Bottom of the Bottomley Case?
…In his post Mr. Roth demonstrated yet again that the government can pursue its enforcement agenda not only at all phases of the civil and criminal cases, but also in…
FDA’s Permanent Injunction Authority: Is There a Crack in FDA’s Resolve to Shut Down a Facility’s Operations?
…other civil injunction cases. It does appear, though, that, in civil injunction cases, if FDA-regulated companies push back against the government’s proposal for a shutdown of company operations, courts may…
Amarin Announces a Proposed Settlement of its First Amendment Lawsuit Against FDA: Coming Full Circle in a New Era of the Regulation of Off-label Promotion
…approval for this additional indication. The company’s plan to obtain approval of the persistently-high triglyceride level indication was derailed when FDA called into question the clinical validity of the triglyceride…
Could the Road to an AKS Violation Be Paved with Good Intentions? Pfizer Asks SCOTUS
…D enrollee’s copay for tafamidis, subject to certain eligibility criteria, including financial need. Eligible patients would be responsible for only $35 per month, and Pfizer would cover the rest of…