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State laws and legislation related to biologic medications and substitution of biosimilars

September 11, 2014 Comments off

State laws and legislation related to biologic medications and substitution of biosimilars
Source: National Conference of State Legislatures

For several decades, every state has regulated the use of brand-name and generic prescription drugs through statutes and agency or board rules. These state actions include when and how generics may be substituted for brand-name prescriptions, by pharmacists or others. Generic drugs typically have active ingredients that are identical to those of their brand-name counterpart. These traditional drugs include familiar pills used regularly by tens of millions of Americans as well as some specialty drugs.

Biologic medicines are much more complex than traditional chemically synthesized drugs. Biologics are manufactured from living organisms by programming cell lines to produce the desired therapeutic substances and consist of large molecules. Common biologics in use today include human growth hormone, injectable treatments for arthritis and psoriasis, the Hepatitis B vaccine and stem cell therapy.

Regulating biologics raises new issues for both state and federal policymakers. Because of their complexity, biologic drugs are much more difficult to replicate than the chemically produced generics for other drugs. The cell lines used and modifications in the manufacturing process affect biologic medicines. As a result, truly identical “generic” versions are currently virtually impossible to produce. However, once patents expire for the existing brand-name biologic drugs, “biosimilar” medicines can be produced, which is an occurrence that raises regulatory issues in the states.

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Transporting Crude Oil by Rail: State and Federal Action

August 29, 2014 Comments off

Transporting Crude Oil by Rail: State and Federal Action
Source: National Conference of State Legislatures

Technological advances such as hydraulic fracturing and horizontal drilling are driving the increase in oil and natural gas extraction and allowing access to shale resources in Canada and the U.S. that were previously uneconomical to develop.

In fact, the United States became the No. 1 producer of oil in the world in 2014—overtaking Saudi Arabia and Russia. The U.S. produced 8.4 million barrels per day of oil in April 2014, which is the highest monthly production volume in more than 25 years—with North Dakota and Texas supplying almost half of the total U.S. crude oil production. The rapid expansion of crude oil production in North America has increased the use of rail, truck, barge and pipeline to carry crude to refineries.

Upon extraction, crude oil is transported to refineries to be processed into useful petroleum products—such as heating oil, diesel fuel or gasoline. According to the U.S. Department of Transportation (DOT), in 2009 70.2 percent of crude oil and petroleum products were transported by pipeline while 23.1 percent were shipped by oil tankers, 4.2 percent by truck and just 2.6 percent by rail. In 2013, crude oil accounted for just 1.4 percent of the commodities carried by rail. Although oil makes up a small percentage of rail freight, this proportion is increasing rapidly.

Driving While Revoked, Suspended or Otherwise Unlicensed: Penalties by State

August 22, 2014 Comments off

Driving While Revoked, Suspended or Otherwise Unlicensed: Penalties by State
Source: National Conference of State Legislatures

All 50 states and the District of Columbia issue driver’s licenses, and conversely, all have penalties for driving without a license. These penalties vary widely, but follow a similar theme: driving without a license is a serious offense that goes beyond a moving violation. Penalties generally involve fines, jail time or both.

The box allows you to conduct a full text search or use the dropdown menu option to select a state.

State Laws and Legislation Related to Biologic Medications and Substitution of Biosimilars

July 24, 2014 Comments off

State Laws and Legislation Related to Biologic Medications and Substitution of Biosimilars
Source: National Conference of State Legislatures

For several decades, every state has regulated the use of brand-name and generic prescription drugs through statutes and agency or board rules. These state actions include when and how generics may be substituted for brand-name prescriptions, by pharmacists or others. Generic drugs typically have active ingredients that are identical to those of their brand-name counterpart. These traditional drugs include familiar pills used regularly by tens of millions of Americans as well as some specialty drugs.

Biologic medicines are much more complex than traditional chemically synthesized drugs. Biologics are manufactured from living organisms by programming cell lines to produce the desired therapeutic substances and consist of large molecules. Common biologics in use today include human growth hormone, injectable treatments for arthritis and psoriasis, the Hepatitis B vaccine and stem cell therapy.

Regulating biologics raises new issues for both state and federal policymakers. Because of their complexity, biologic drugs are much more difficult to replicate than the chemically produced generics for other drugs. The cell lines used and modifications in the manufacturing process affect biologic medicines. As a result, truly identical “generic” versions are currently virtually impossible to produce. However, once patents expire for the existing brand-name biologic drugs, “biosimilar” medicines can be produced, which is an occurrence that raises regulatory issues in the states.

Currently, there is concern that traditional statutes regulating “generic drugs” may be misapplied to new products that are not identical. This has led to a recent move to amend older state laws to address the medical and chemical characteristics of these “biologics,” as well as any future generic-style “follow-on biologics” or “biosimilars.”

In the past one and a half years at least 23 states have considered legislation establishing state standards for substitution of a “biosimilar” prescription product to replace an original biologic product.
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NCSL — Child Migrants to the United States

July 17, 2014 Comments off

Child Migrants to the United States
Source: National Conference of State Legislatures

The U.S. is experiencing a dramatic increase in the number of unaccompanied children arriving on the southern border, gaining humanitarian and political attention and challenging federal and state resources and management. As of June 14, 2014, more than 52,000 children have been apprehended, a doubling of arrivals compared to last year.

Federal responsibility for unaccompanied children is divided between the U.S. Department of Homeland Security (DHS) and the U.S. Department of Health and Human Services (HHS). Children in DHS custody who are under age 18 without a parent or guardian must be screened and transferred to HHS within 72 hours. The Office of Refugee Resettlement (ORR) in HHS reunites the child with family or a friend, or in approximately 10 percent of the cases, places them in foster care, pending court review of their immigration claims. After being placed either with a sponsor or in foster care, every child is put into deportation proceedings. The children may then be granted permission to stay (for example, through family visas, special immigrant juvenile visas or asylum); choose to leave voluntarily; or be removed from the United States.

The surge in children crossing the border has placed an immense strain on federal agencies to process and care for them. The agencies have responded by identifying shelters and processing facilities, redirecting staff and funds, and activating an interagency group coordinated by the Federal Emergency Management Agency (FEMA). DHS and the Department of Justice (DOJ) have assigned more staff to apprehend and process children and families crossing the Texas border. ORR has requested approval from Congress to address a budget shortfall for unaccompanied children by shifting funding from state-administered refugee programs.
Potential state impacts include: budget shortfalls in state administered refugee programs and implications for state services; state licensing and oversight of care providers for unaccompanied children; and communication/coordination of federal enforcement and emergency response with state law enforcement.

In a June 30, 2014 letter to congressional leaders, the president provided an update on the administration’s response to the humanitarian crisis and a request for support for an emergency supplementation appropriation. The request for $3.7 billion in emergency funding, submitted July 8, 2014, would provide an additional $3.7 billion in emergency funding: $1.6 billion to DOJ and DHS; $1.8 billion to HHS; and $300 million to the Department of State.
This brief highlights recent trends in arrivals of unaccompanied children, an overview of the federal unaccompanied minor program, federal budget proposals to respond to the increased arrivals, and benefit eligibility for unaccompanied migrant children.

NCSL Launches Elections Administration Research Database

June 26, 2014 Comments off

NCSL Launches Elections Administration Research Database
Source: National Conference of State Legislatures

What is the impact of major court rulings on voter ID laws?

How are states ensuring voter registration lists are accurate?

Which new voting system designs are being developed for the marketplace?

Finding these answers and other information about elections policy can quickly eat up the kind of time that a lawmaker, legislative staffer or elections administrator can hardly afford to spend.

But that was life before the Elections Administration Research Database, a new tool launched today by the National Conference of State Legislatures. The database brings together more than 1,900 reports that, altogether, address a wide range of elections topics. It is supported by generous funding from The Pew Charitable Trusts.

The collection includes reports dating back to 2000 and reflects a variety of perspectives, from election administrators to nonprofit organizations to academic researchers. The reports are grouped by subject, author, publication and state and can be searched by a combination of these categories, or by date ranges or a specific article title.

Common Law Marriage by State

June 19, 2014 Comments off

Common Law Marriage by State
Source: National Conference of State Legislatures

To be defined as a common-law marriage within the states that allow it, the two people must: agree that they are married, live together, and present themselves as husband and wife. Common-law marriage is generally a non-ceremonial relationship that requires “a positive mutual agreement, permanent and exclusive of all others, to enter into a marriage relationship, cohabitation sufficient to warrant a fulfillment of necessary relationship of man and wife, and an assumption of marital duties and obligations.” Black’s Law Dictionary 277 (6th ed. 1990).

Before modern domestic relations statutes, couples became married by a variety of means that developed from custom. These became the elements of a “common-law marriage,” or a marriage that arose through the couple’s conduct, instead of through a ceremony. In many ways, the theory of common-law marriage is one of estoppel—meaning that couples who have told the world they are married should not be allowed to claim they aren’t when in a dispute between themselves.

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