Law Commons^™

Legal Impediments To The Diffusion Of Telemedicine, Diane E. Hoffmann, Virginia Rowthorn

Diane Hoffmann

No abstract provided.

Penny Wise But Pound Foolish In The Heartland: A Case Study Of Decriminalizing Domestic Violence In Topeka, Kansas, Shelley Santry

Shelley M. Santry

Interests In The Balance: Fda Regulations Under The Biologics Price Competition And Innovation Act, Parker Tresemer

Parker Tresemer

Recent biotechnology advances are yielding potentially life-saving therapies, but without FDA regulations designed to minimize product costs, patients will continue to be unable to afford these expensive biologic products. Many believe that these prohibitive costs stem from weak competition from generic biologic products, also known as follow-on biologics. To correct this deficiency, and to address the often conflicting regulatory and policy concerns associated with biologic products, Congress enacted the Biologics Price Competition and Innovation Act. The Act created an abbreviated approval pathway for biologic products and, if effective, could increase competition while driving down product costs. But legislation alone is …

Fda Accelerated Approval Program: Why Brake When You Can Get A Mandate?, Keren Frumkin

Keren F. Bisnauth

The FDA approval process is designed to ensure that the drugs released for public consumption are safe and effective. In 1992, the FDA implemented the Accelerated Approval process in order to expedite the approval of drugs to aid patients with life-threatening illnesses, who have little to gain from lengthy approval processes, and who cannot risk worsening health conditions. However, the questionable post-approval practices of drug manufacturers, coupled with the lax FDA enforcement of its required follow-up protocols have raised doubts as to the true value of expedited approval procedures, as well as an influx of drug recalls and lawsuits. In …

Assessing Public Health Strategies For Advancing Child Protection: Human Trafficking As A Case Study, Jonathan Todres

Jonathan Todres

Ensuring the well-being of all children is one of the great challenges of our time. Despite concerted efforts in the United States to protect children, research reveals that millions of children suffer harm each year. Frequently, when policymakers and child advocates speak of “child protection,” they focus primarily on abuse and neglect in the home. Often, child protection does not contemplate violence against children in the community. The inside/outside-the-home divide is somewhat of a false dichotomy, however, as the two realms are interrelated. Children who suffer abuse and neglect in the home are frequently at heightened risk of exploitation outside …