News & Analysis as of

Don’t Flush the Drugs! The EPA is Coming!

The Environmental Protection Agency (EPA) recently issued a pre-publication Proposed Rule (40 C.F.R. part 266, subpart P) regulating the management and disposal of drugs deemed “hazardous waste pharmaceuticals” by healthcare...more

Does CPSC or FDA Have Jurisdiction Over Your Consumer Product?

As our readers know, we write about legal developments that affect companies involved in manufacturing, importing, distributing, and/or selling “consumer products.” In many cases, these products fall squarely within the...more

House Approves "Ensuring Patient Access and Effective Drug Enforcement Act"

On April 21, 2015, the House of Representatives approved H.R. 471, the Ensuring Patient Access and Effective Drug Enforcement Act of 2015. The bipartisan legislation would clarify the Controlled Substances Act to establish...more

Illinois Appellate Court Finds Admitted Off-Duty Marijuana Use Does Not Bar Unemployment Insurance Benefits

Is an employee entitled to receive unemployment insurance benefits after being terminated for admittedly smoking marijuana while on vacation? According to a recent, and counter-intuitive, decision by the Illinois Appellate...more

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

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

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

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