C&M Health Law

JANUARY 25, 2023

Health Care Provisions included in the Consolidated Appropriations Act, 2023 The following sections outline the Act’s health care provisions and accompanying explanatory report and provide funding levels for Department of Health and Human Services (HHS) agencies.

Medicaid 104

Medicaid Medicaid Medicare Medicare 104

Kaiser Health News

JANUARY 12, 2023

On one hand, the FDA has relaxed some of the risk evaluation and mitigation strategies (REMS) from the prescribing rules surrounding abortion pills. The FDA puts these extra restrictions or safeguards in place for certain drugs to add additional protection. Some advocates say these pills simply do not bring that level or risk.

US Department of Health and Human Services 52

US Department of Health and Human Services FDA Medicare Medicare 52

Drug & Device Law

DECEMBER 21, 2023

FDA , 78 F.4th 2023), was the Fifth Circuit’s blatantly politicized attack on the FDA’s regulation of abortion-related drugs. The questionable allegations of that single complaint thus effectively trumped many years of the FDA’s science-based decision-making. The FDA, for one, advised patients to keep using these drugs.

FDA 52

FDA Fraud Informed Consent 52

Drug & Device Law

JULY 24, 2023

Nonetheless, the Ninth Circuit’s PATDC82 I allowed a RICO claim alleging that, between 1999 and 2011, defendants concealed that risk from the FDA and that, as a result, every TPP in the country paid for Actos prescriptions that it otherwise would not have reimbursed. But the FDA has concluded just the opposite. 3d 1243 (9th Cir.

Fraud 52

Fraud FDA Doctors 52

Drug & Device Law

AUGUST 8, 2022

A myriad of other industry, medical, and online organizations certify and rate an almost endless variety of goods and services. Smith, LLC , 2010 WL 11566367, at *7 (N.D. May 14, 2010) (“Defendant [standards institute’s] standards are voluntary, consensus standards, and Defendant. . . Such power rests solely with the FDA.”

Doctors 52

Doctors Fraud Licensing Compliance 52

Drug & Device Law

APRIL 25, 2022

Back in 2010, we examined one restrictive judicial gloss on Rule 407 – a “policy” based exception that the rule somehow doesn’t apply to government-mandated measures. Fortunately, that 2010 decision has been a pro-plaintiff anomaly, and FDA required label changes, recalls, etc. Zoll Services, LLC , 2019 WL 3883682, at *1-2 (S.D.

FDA 52

FDA Governance 52

Drug & Device Law

MARCH 7, 2022

2010) (applying TwIqbal because “[p]unitive damages are never awarded as a matter of right, are disfavored by the law”). These allegations lack any contention or inference that [defendant] withheld or misrepresented information to the FDA. . ., 2010) (other citations and quotation marks omitted). Corrections Corp. , 2, 2020). “In

Fraud 59

Fraud FDA Licensing Pharmaceutical Industry 59

Drug & Device Law

MARCH 13, 2023

If “strict liability” design defect claims are allowed under Pennsylvania law, the other side hopes to use Lewis and its Pennsylvania progeny to argue that all evidence of a prescription medical product’s compliance with the FDCA and FDA regulations is completely inadmissible. Central Medical Health Services, Inc. , 393, 400 (2010).

FDA 59

FDA Compliance Governance Doctors 59