Drugs

News & Analysis as of

Ebola and Emergency Access to FDA Unapproved Drugs in Life-Threatening Situations

As public health officials accelerate their efforts to develop a vaccine to combat Ebola—one that the U.S. Food and Drug Administration (FDA) has not yet approved for use—some may ask if there is ever an option for critically...more

“Prescription” v. “Recommendation”: How State Medical Marijuana Laws May Insulate Treating Physicians From Liability Under The...

As of today, twenty states and the District of Columbia have legalized marijuana for medicinal purposes. (A complete list of the states which have legalized marijuana use, including summaries of each state’s use laws can be...more

Getting Ahead of the Changing Legal Landscape Around Marijuana Use: Avoiding Nine Common Policy Mistakes

Once a policy that typically needed little attention or updating, the legalization of marijuana — even for the limited purpose of medical use — is throwing companies’ drug & alcohol use policies into the spotlight. ...more

Labor & Employment E-Note - April 17, 2014

In This Issue: - Employers Face Increasing Number of Religious Bias Suits - Small Business Owners Concerned About Overtime Pay Requirements - Rising Number of Wage Theft Lawsuits Highlight Enforcement Issues -...more

Health Care Update

In This Issue: - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Other Congressional and State Initiatives - Other Health Care News - Upcoming Hearings and...more

BakerHostetler Patent Watch: Galderma Labs., L.P. v. Tolmar, Inc.

On December 11, 2013, in Galderma Labs., L.P. v. Tolmar, Inc., the U.S. Court of Appeals for the Federal Circuit (Newman, Bryson, Prost*) reversed the district court's judgment that U.S. Patents No. 7,579,377, No. 7,737,181,...more

Reefer Madness: Employees May Use Medical Marijuana Yet Be Fired For Doing So

Despite twenty states allowing the use of medicinal marijuana and two more – Colorado and Washington – allowing recreational marijuana use, employers remain unaffected. Courts consistently find that employers may terminate...more

Connecticut Medical Marijuana Statute Is It Sowing the Seeds of Employer Discontent?

With the enactment of Connecticut’s medical marijuana, Connecticut became the 17th State in the Union to pass legislation legalizing the use of pot in one way or another. As of today, 20 states and the District of Columbia...more

New Medical Marijuana Law Will Impact Illinois Employers

On August 1, 2013, Illinois Governor Pat Quinn signed into law the Compassionate Use of Medical Cannabis Pilot Program Act, a four-year pilot program legalizing the use of marijuana for medical purposes. Illinois is the 20th...more

HRSA Clarifies 340B Orphan Drug Exception But 340B Audit Enforcement Remains Murky

Recently, HRSA publicly announced the issuance of a final rule clarifying when 340B covered entities can purchase and distribute orphan drugs through the 340B Drug Pricing Program. Separately, HRSA quietly posted a report on...more

Senate HELP Committee Releases Revised Senate Bill Providing Federal Oversight for Compounding Pharmacies

Compounding Legislation Continues to See More Changes - The Senate HELP Committee has released a revised draft Senate Bill ("Revised Senate Bill"), updating the committee's first proposed compounding bill and signaling...more

FDA Issues Proposed Rules That Give FDA Administrative Detention Authority with Respect to Drugs

On July 15, 2013, the U.S. Food and Drug Administration (FDA) released proposed rules implementing sections of the Food and Drug Administration Safety and Innovation Act (FDASIA) and the FDA's new authority to protect the...more

News and Insights from Austin - Q2 2013

Welcome to the summer issue of News and Insights. In this issue, I’m proud to highlight Becca McKnight, who was recently selected by The Food and Drug Law Institute (FDLI) to serve on its Medical Devices Committee. Becca...more

Supreme Court Holds FDCA Preempts Common Law Design-Defect Claim Against Generic Drugs

On June 24, 2013, the U.S. Supreme Court held in Mutual Pharmaceutical Co., Inc. v. Bartlett that the Federal Food, Drug, and Cosmetic Act (FDCA) preempted the respondent's common law claim for damages arising from the...more

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