Tag: FDA

April 24, 2014

FDA Says Product Containing No Tobacco is a “Tobacco Product” – FDA Expands Authority to Include E-Puffing

In an effort that Food and Drug Administration (FDA) officials say was motivated by the (Big Brother?) desire “to correct a misperception by consumers that tobacco products not regulated by FDA are safe alternatives to currently regulated tobacco products,” the FDA released proposed regulations this morning that would regulate the rapidly growing e-cigarette market. (The… Read More

March 6, 2014

Electronic Cigarette Advertising Practices Draw Legislative Attention – Will Regulations Follow?

Advertisements for electronic cigarettes, or “e-cigarettes,” are increasingly drawing scrutiny from consumer advocates and public health groups who are calling for the federal government to regulate these advertisements in the same manner that traditional cigarette advertisements are regulated. The e-cigarette industry is growing at a rapid pace, particularly among younger people. Last year, the industry… Read More

February 28, 2014

Omnicare Decision Limits the Reach of False Claims Act

A recent decision by the Court of Appeals for the Fourth Circuit limiting the reach of the False Claims Act demonstrates how relators who pursue cases in which the government declines to intervene can end up making law that is unfavorable to the government’s enforcement of that statute. United States ex rel. Rostholder v. Omnicare,… Read More

February 12, 2014

Wild, Wild West: The Legalization of Marijuana Brings Lots Of Regulatory Concerns

The beginning of 2014 has brought many new laws into effect and we have written on a number of them. But few laws have received more mainstream media exposure than Colorado’s legalization of recreational marijuana. Of more importance to us, the legalization of recreational marijuana has posed some interesting problems for regulators. The most obvious… Read More

January 27, 2014

Healthcare Fraud Recoveries at All-Time High Since 2009

Fiscal year 2013 marked the fourth consecutive year in which the Department of Justice has recovered at least $2 billion from cases involving charges of healthcare fraud.  Make no mistake: these record-setting yields were no accident.  The Obama Administration has prioritized busting healthcare fraudsters since it took office, and for good reason.  A 2009 analysis… Read More

October 24, 2013

FDA Regulations on the Horizon for Billion Dollar E-Cigarette Industry

In September, 40 state attorneys general wrote to the U.S. Food and Drug Administration (FDA) asking the agency to take all available measures to issue regulations on the advertising, ingredients, and sale to minors of electronic cigarettes, also known as e-cigarettes or e-cigs. The full text of the letter is available here. The FDA has set… Read More

January 4, 2013

Are the Feds Enlisting FedEx to Police the Illegal Pharma Market?

The government may be coming up with a new cost-effective measure to help balance the federal budget – enlisting private companies to do their policing. A 2011 settlement between the Justice Department and Google for $500 million is one recent example. Under the settlement, Google acknowledged responsibility for improperly aiding rogue pharmacies by allowing the… Read More

December 6, 2012

‘Off-Label’ FDA Cases Can Run Afoul of First Amendment, Appeals Court Holds

A recent decision by the U.S. Court of Appeals for the Second Circuit may significantly curtail enforcement efforts relating to the so-called “off-label” use of drugs approved by the Food and Drug Administration for specific uses and/or populations. Finding that the government’s prosecution of promotional statements supporting off-label use of an FDA-approved drug would violate… Read More

October 6, 2012

In ‘Bitter Pill,’ FDA Seizes Domain Names of Firms Selling Illegal Pharmaceuticals

In an aggressive step against businesses selling drugs online, the U.S. Food and Drug Administration, in conjunction with the U.S. Department of Homeland Security, took legal action earlier this month against more than 4,100 websites this week that led to criminal charges, seizures of illegal products, and hundreds of domain name seizures. This year Operation… Read More