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1] Originally enacted in 2010, the Online Prescribing Act has allowed health care providers to register with the State to prescribe and dispense certain FDA-approved drugs via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. Once signed into law, the effect of H.B. 152 , amending Utah Code § 26-60-103.

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. 18 U.S.C. § Are the proposed record-keeping obligations reasonable and/or sufficient? 1301.28.

Telemedicine 52

Telemedicine COVID-19 FDA Compliance 52

Drug & Device Law

OCTOBER 10, 2022

The drug at issue was an FDA-recognized breakthrough drug that treats a relatively rare, but invariably fatal, condition – transthyretin amyloid cardiomyopathy (“ATTR-CM”). 3 (2008), the court explained that “the word ‘includes,’ when used in a statute, ‘is usually a term of enlargement, and not of limitation.’” Pfizer, Inc. ,

Medicare 52

Medicare Medicare FDA Prescription Drug Pricing 52

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 ).

FDA 59

FDA Fraud Governance Compliance 59

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.

FDA 72

FDA Fraud Governance Medicare 72

Drug & Device Law

JULY 18, 2023

As evidenced by our PMA Preemption Score Card , on which today’s case became the 651 st entry, defendant manufacturers of FDA-approved Class III medical devices generally do pretty well with preemption motions. The device was pre-market approved by the FDA in 1996 and has been sold throughout the United States ever since. 312 (2008).

FDA 52

FDA Fraud Governance 52