FDA Law

AUGUST 4, 2022

Recognizing that this out-of-pocket cost still represents a significant financial barrier for many patients, Pfizer proposed a Direct Copay Assistance Program for Medicare Part D beneficiaries using tafamidis. Under Medicare’s pricing formula, beneficiaries who take tafamidis are responsible for a copay of approximately $13,000 per year.

Manufacturing 98

Manufacturing Medical Government IT 98

FDA Law

SEPTEMBER 22, 2022

While the authors did a yeoman’s job of combing through the criminal cases to identify what they view as a “handful” of cases and call for increased use of the Park doctrine, we at the FDA Law Blog respectfully disagree. The JAMA editorial notes that there are few Park cases for two primary reasons: [The government] may lead.

Private Practice 59

Private Practice Government Individual Specialization 59

GeriPal

JANUARY 11, 2024

In further contrast to the United States, MAID in Canada is almost entirely administered by a clinician, whereas in the United States patients must self administer. A planned expansion of MAID to include people with mental illness was placed on hold until March 2024. They could have a prognosis of years, or decades.

Illness 144

Illness IT Medical Provider 144

GeriPal

MARCH 16, 2023

Rosanne: I think I was motivated by the number of times patients asked me to get rid of their pot-bellies, quite honestly. So I felt like over all these years I have learned so much from my patients and from the science, that it should be out there in one place where people can easily access it and help themselves.

IT 105

IT Healthcare Professional Healthcare Transportation 105

FDA Law

MAY 19, 2022

By Faraz Siddiqui — Last June, we blogged about a lawsuit brought by the Pharmaceutical Research and Manufacturers of America (PhRMA) challenging CMS’s ill-conceived Accumulator Adjustment Rule (“final rule”), which amended the Medicaid Rebate best price regulation. On Tuesday, May 17, 2022, the D.C.

Manufacturing 40

Manufacturing Patients Insurance Government 40

FDA Law

JANUARY 9, 2024

The government would require at least another 30 days to examine the shipment at the U.S. For example, the Canadian government reiterated its commitment to safeguard Canada’s domestic drug supply and has issued regulations to prohibit bulk exports to the United States that will cause or worsen drug shortages in Canada.

Supply Chain 59

Supply Chain Manufacturing Chronic Condition Government 59