Health Law Advisor

MARCH 1, 2023

1] Originally enacted in 2010, the Online Prescribing Act has allowed health care providers to register with the State to prescribe and dispense certain FDA-approved drugs via online pharmacies and utilization of telehealth visits. Utah Code § 58-83-306.

Telemedicine 52

Telemedicine COVID-19 Fraud Licensing 52

Health Law Advisor

MARCH 7, 2023

Background on the Ryan Haight Act The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the “Ryan Haight Act”) made certain amendments to the CSA which established controls on the remote prescribing of controlled substances. Are the proposed record-keeping obligations reasonable and/or sufficient? Impact on Pharmacies. 1301.28.

Telemedicine 52

Telemedicine COVID-19 FDA Compliance 52

Drug & Device Law

MAY 4, 2023

2015), finally gave appellate recognition to the preemption of design defect claims for FDA-approved branded prescription drugs. FDA approved the drug with its particular formulation and the manufacturer could not have changed the formulation on its own. 440 (2008), in the face of a contrary ruling from the Sixth Circuit in Garcia v.

FDA 64

FDA Fraud Compliance 64

Drug & Device Law

JANUARY 30, 2023

440 (2008) Buckman was not cited at all in the Merck Sharp & Dohme Corp. 470 (1996), was decided – removing express preemption as a defense for manufacturers of §510(k) products So defendants moved on fraud on the FDA under an implied preemption theory and won. Plaintiffs Legal Committee , 531 U.S. Kent , 552 U.S.

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FDA Fraud Governance Medicare 72

Drug & Device Law

SEPTEMBER 18, 2023

He came across several preemption decisions involving defendants who employed the FDA’s “alternative summary reporting” (“ASR”) system that the agency operated for about 20 years, “from 1997 through June 2019.” without adversely affecting FDA’s ability to monitor and react to such events. 18, 2022) ( available here ).

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FDA Fraud Governance Compliance 59

Drug & Device Law

MAY 5, 2022

2022), a short decision that came out the right way, but did so based on a problematic statute that creates a rebuttal presumption that warning labels approved by the FDA are adequate as a matter of state law. Stated differently, the rebuttal provision makes allegations and evidence of fraud on the FDA a prerequisite to state-law liability.

Compliance 52

Compliance FDA Fraud 52