This morning, the United States Senate Committee on Finance questioned Pres. Biden's nominee, Chiquita Brooks-LaSure, for Administrator for Centers for Medicare and Medicaid Services (CMS).
1 . LIFE SCIENCES REGULATORY FRAMEWORK
1.1 Legislation and Regulation for Pharmaceuticals and Medical
Devices
The primary legislation governing the authorisation, marketing,
sale and supply of pharmaceutical products by the US Food and Drug
Administration (FDA) is the Federal Food, Drug, and Cosmetic Act
(FD&C Act), which has been amended many times over the years to
reflect increasing FDA mandates for the regulation of
pharmaceutical products. The Public Health Service Act (PHS Act) is
the specific authority utilised to approve or license biologic
(including biosimilar) products. The primary FDA regulations
governing drugs and biologics are found at Chapter 21 of the Code
of Federal Regulations. Controlled substances, such as opioids, are
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Pharmacy benefit managers (PBMs) should consider the
implications of a model law making its way through the National
Association of Insurance Commissioners (NAIC) that would establish
a licensure requirement and rules of conduct for these participants
in the health care marketplace. A number of states have already
adopted their own PBM laws, and an NAIC model would be likely to
motivate others to do so.
On April 12, 2021, the NAIC s Health Insurance and Managed
Care Committee, meeting by videoconference at the NAIC s Spring
National Meeting, briefly discussed the PBM Model Act, agreeing to
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Today s post discusses a recent implied-preemption decision
that is relevant beyond the generic-drug context in which it
arose.
A bit of background first.
In
Buckman Company v. Plaintiffs Legal Committee,
531 U.S. 341 (2001), the Supreme Court held that 21 U.S.C. §
337(a)-which declares that all actions to enforce the FDCA shall be by and in the name of the United
States -impliedly preempts any private suit seeking to enforce
the FDCA. Thus, under
Buckman, a state-law tort claim is
barred by federal law if it exist[s] solely by virtue of the
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On March 2, 2021, the City Council of Santa Ana, California,
passed an urgency ordinance establishing premium pay for
grocery and retail pharmacy workers during the COVID-19 pandemic.
Santa Ana is the county seat of Orange County, located southeast of
Los Angeles. The ordinance requires that large grocery stores and
pharmacies in Santa Ana provide their workers with premium pay of
$4.00 for each hour worked. The ordinance went into effect on March
3, 2021, and will expire on June 30, 2021.
Covered Employers and Employees
The ordinance defines covered employers as grocery store or