Prescription Drugs

The Supreme Court has long resolved whether and when state law claims against drug manufacturers are preempted by federal law. The Third Circuit ruling in Merck Sharp & Dohme Corp. v. Albrecht is very favorable to state-law claims and likely will be modified, if not reversed, by the Supreme Court.

The Food and Drug Administration’s (FDA) approval of a drug warning label does not necessarily insulate drug manufacturers from state-law failure-to-warn claims. In Wyeth v. Levine (2009), the Supreme Court held that state failure-to-warn claims are preempted when there is “clear evidence” the FDA would not have approved the warning a plaintiff claims was necessary. In Merck Sharp & Dohme Corp. v. Albrecht, Merck claims there was such “undisputed” evidence in this case but the Third Circuit improperly allowed the case go to a jury for “conjecture as to why the FDA rejected the proposed warning.”

Three speakers provided a look at major health policy issues, with emphasis on state policy options available in 2017. Michael Williams discussed health equity and disparities and how they drive health care costs. Dania Palanker reviewed health insurance exchanges and provided data for the 2016 open enrollment period. She also looked at the major policy proposals being considered by the incoming Trump administration. Ameet Sarpatwari analyzed pharmaceutical drug pricing and state policy recommendations recently developed by a work...

In 2016, five states enacted legislation designed to mitigate a controversial health insurance procedure known as step therapy, which requires patients to try less expensive, often generic medications before being approved for costlier treatments. With the growing availability of generics step therapy, alongside prior authorization and benefit tiers, has emerged as a popular cost savings tool for private insurers, as well as Medicaid and Medicare programs.

Insurance companies and...

On July 5, 2016, Hawaii became the third state to require all public and private health insurance providers to cover 12 months’ worth of contraceptives at one time. Other states introduced similar legislation in 2016. Research has shown that this change could have enormous effects.

Kaiser Family Foundation has posted an excellent web panel discussion on drug pricing. Representatives from Pfizer, a large international pharmaceutical company; Express Scripts, and Aetna, a major health insurance carrier, talk with Larry Levitt, a Kaiser senior vice president.

Zubik v. Burwell, involving religious nonprofit objections to providing notice objecting to the Affordable Care Act’s (ACA) birth control mandate, does not directly affect state and local government. But it is one piece of a litigation puzzle over this law; most of the puzzle pieces do affect state and local government. In a three-page unauthored opinion the Court did not rule on the merits of the case leaving the lower courts to “resolve any outstanding issues.”

The ACA regulations requires employers offering health insurance to cover certain contraceptives unless employers object on religious grounds. Religious nonprofits claim that submitting a form to their insurer or the federal government saying they object to providing contraception coverage on religious grounds violates the Religious Freedom Restoration Act.  

From economic and workforce development, to infrastructure and education, any number of items could have dominated discussions during the winter meeting of the National Governors Association, or NGA, in February. Yet, as the governors began to immerse themselves in committee reports and assemble a list of priorities for their meeting with President Barack Obama at the White House, it was the issue of opioid abuse and overdose deaths that dominated the agenda.

The U.S. Food and Drug Administration announced yesterday it will require “black box” warnings on all immediate-release opioid pain medications. The target of the warning is prescribers.

On Sept. 21, news that Turing Pharmaceuticals raised the price of a 62-year-old drug by 4,000 percent overnight made headlines. The drug, Daraprim, is critical to the care of HIV and AIDS patients. The sharp rise in price from $18 to $750 per pill is part of the all-too-familiar trend of drug-price spiking in the United States and highlights concerns about the sustainability of health care.

Biological products are a growing class of medicines available to treat disease. Biological products differ from traditional drugs in a few key ways. Biologics are manufactured in living cells, while drugs are manufactured through a chemical process. Biosimilars, interchangeable biologicals and follow-on biologics are the names given to the “generic” versions of brand-name biologics. Even after an interchangeable biological is approved by the FDA, it must meet additional requirements to be considered “interchangeable.” The FDA must determine that the biosimilar can be expected to produce the same clinical result as the brand-name product in any patient and that it has similar safety risks as the brand-name product. At the point that the FDA deems a biosimilar interchangeable, state law will govern how substitutions will be allowed.

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