Prescription Drugs

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.

Terminally ill individuals in Colorado, Louisiana and Missouri will now be able to try experimental drugs or treatments that have not yet been approved by the FDA.

The idea of allowing terminally ill patients access to experimental drugs and treatments is thought to have been inspired by Dallas Buyers Club, a movie about an AIDS patient who smuggles treatments from Mexico because they were not legal in the U.S.

Under the bills, patients that have exhausted every other possible drug or treatment who obtain the...

In the 12 years since New Hampshire mandated health insurance companies to cover contraceptive services, no one has asked for repeal.  That is, until the controversy broke out last month over exempting religious organizations from President Obama’s national mandate, New Hampshire Rep. Terie Norelli told CSG. The 1999 legislation, which Norelli co-sponsored, does not contain any exemption for religious organizations. 

States already have grappled with insurance coverage of contraceptives before the Obama administration issues rules in 2012 called for under the Affordable Care Act. Twenty-six states have passed laws mandating insurance coverage for contraceptives; another two have administrative rulings requiring coverage. Nineteen states also have included exemption provisions for religious organizations. The Hawaii statute was the model used for the Obama compromise on exemptions.

Prescription drug abuse continues to be recognized as the nation’s fastest-growing drug problem.  The latest “Monitoring the Future” study from the University of Michigan indicated that prescription drugs are second only to marijuana in their frequency of abuse. In Kentucky, the rate of overdoses from prescription drugs doubled among men and tripled among women between 2000 and 2009. In Florida, estimates suggest as many as seven people are dying daily from accidental overdoses. Deaths from prescription drug overdoses are the leading cause of accidental death in 17 states.

A recent National Survey on Drug Use and Health found prescription medication abuse is a significant societal health issue, with more Americans abusing prescription drugs than cocaine, heroin, hallucinogens and inhalants combined. It also found that one in five teens will abuse a prescription medication at least once in their lifetime.  Preventing prescription drug abuse and misuse, an epidemic in our country, is one of the key strategic priorities of the Cardinal Health Foundation.