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Court Determines that Decade’s Worth of Missing Data Must Be Published on ClinicalTrials.gov but Enforcement of Reporting Violations Hinges on FDA Discretion
…companies, medical device manufacturers and academic institutions will be required to post clinical trial data from clinical trials conducted during this time period. The plaintiffs in Seife v. HHS are…
FTC Seeks Public Comment on its Endorsement Guides
…codify elements of the currently voluntary endorsement guides so that violators can be liable for civil penalties and damages under 15 U.S.C. §§ 45(m)(1)(A) & 57. He also suggests instituting…
PhRMA Challenges Oregon Drug Pricing Transparency Laws
On December 9, 2019, the Pharmaceutical Research and Manufacturers of America (PhRMA) filed a civil action in the United States District Court for the District of Oregon seeking declaratory and…
FDA Warns Against Use of Registration Certificates: It Don’t Mean A Thing
…a thing” “if it ain’t got that” 510(k) clearance, PMA approval, de novo classification or EUA authorization – not as catchy as when Ella Fitzgerald and Duke Ellington sing it….
FDA Proposes to Ban Brominated Vegetable Oil in Food
…Moreover, California recently enacted the California Food Safety Act, prohibiting the manufacturing, selling, delivering, distributing, or holding food that contains BVO, with a $5,000 civil penalty for first violations, as…
Join Us for an HPM Webinar: Recent Hospital Controlled Substance Diversion Cases — Cautionary Tales; Tuesday, October 3, 2023: 12:00-12:45
More than 40 registrants — primarily hospitals and pharmacies — have paid significant civil penalties of up to $5,000,000 to settle allegations they failed to report controlled substance thefts or…
Think Twice Before Sharing: Court Compels Disclosure of Settlement Presentations in Relator’s Qui Tam Suit
…the matter. U.S. ex rel. Higgins v. Boston Scientific Corp., 11-cv-02453, Dkt. No. 279 (D. Minn. Aug. 28, 2019). As set forth in the Justice Manual, a defendant is eligible…
FDA Law Alert: Issue #2
…decision lowers the standard for the government to withhold from disclosure confidential commercial or financial information it receives from regulated industry. In their post, Anne Walsh and Ricardo Carvajal describe…
Holidays and Red Herrings: FDA’s “Nonenforcement Discretion” Successfully Challenged
…FDA would not be ordered to require egg producers to label commercial eggs as being from “free range” or “cage free” hens, or from “caged hens.” Compassion over Killing v….
Is the Government All Fired Up About Charging Individuals?
…false certifications that the products met safety standards. Even though the government touts this case as the “First-Ever Criminal Prosecution for Failure to Report” under the CPSA, the allegations describe…
In a Parallel Universe: FDA Authorizes First REMS “Parallel System”
…Agency’s waivers process. Now, the market has borne the fruits of that labor in the form of a “Parallel System (PS)” REMS. Just last week, FDA approved the first Parallel…
Why are Post-Approval Pregnancy Studies Post-Marketing Requirements Rather Than Post-Marketing Commitments?
…action. Potential enforcement actions can include an FDA Warning Letter, charges under section 505(o)(1) of the FDCA, misbranding charges under section 502(z), or civil monetary penalties. In contrast, failure to…
Congress Passes Legislation To Regulate Controlled Substance Dispensing Over the Internet
…penalties for the illegal distribution of schedule III-V controlled substances and provide state Attorneys General with the ability to bring civil action in federal district court to enjoin Internet pharmacies….
HP&M’s Frank Sasinowski to Present at Kinexum’s “Wow or Yeow?! FDA Outlook for 2021 and Beyond”
2020 was unprecedented and tumultuous due to simultaneous challenges of a once-in-a-century global pandemic, the resulting socio-economic fallout, and political polarization regarding policy responses to the pandemic, civil rights protests…
New Prescription Drug Price Transparency Law in Virginia
…by the PBM, the rebates distributed to health benefit plans, and the rebates passed on to enrollees of health benefit plans. Manufacturers are required to submit annual reports for each…