Category Archives: Drugs

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FDA Issues Draft Guidance Encouraging Innovative Approaches to Expand Access to OTC Drugs

FDA recently released a new draft guidance, “Innovative Approaches for Nonprescription Drug Products,” that described two “innovative approaches” that sponsors of new drug applications may wish to consider to demonstrate the safety and effectiveness of nonprescription drugs.  In announcing the draft guidance, FDA Commissioner Scott Gottlieb explained that the agency sees an opportunity to “foster … Continue Reading

Senator Schumer Introduces Legislation to Decriminalize Marijuana at the Federal Level

Making good on this April 20th announcement, Senator Chuck Schumer (D-NY) introduced legislation that would upend current federal regulation of marijuana. Specifically, the Marijuana Freedom and Opportunity Act removes marijuana from the list of scheduled substances under the Controlled Substances Act, effectively decriminalizing it at the federal level.  Under the bill, states would continue to … Continue Reading

Unanimous Recommendation for Cannabis-Based Epilepsy Drug; Trump Administration Lifts Threat of Cannabis Enforcement in States With Legalization; Schumer To Introduce Bill Decriminalizing Marijuana

On this auspicious April 20th, three developments in the world of cannabis regulation caught our attention.  The first is the unanimous recommendation by a panel of outside advisers to FDA in favor of approving Epidiolex, an epilepsy drug manufactured by GW Pharmaceuticals.  The active ingredient in Epidiolex is cannabidiol (CBD), which is a chemical found … Continue Reading

Advertising Marijuana Businesses: The Federal Criminal Law You Need to Know

As the gravitational pull toward marijuana legalization continues, new sources of revenue continue to emerge. Former Republican House Speaker John Boehner (and former opponent of legalization) recently announced that he joined the board of directors for a cannabis company, and sales of cannabis in California are expected to exceed $3.5 billion in 2018 and to … Continue Reading

Trump and DOJ Pledge to Get Tough on Opioids

On Monday, President Trump delivered an opioid speech in New Hampshire in which he promised to get tough on opioid investigation and enforcement. This follows on the Department of Justice’s (“DOJ”) prior assertion that it will strengthen its efforts against pharmaceutical industry members. On February 27, 2018, the DOJ announced the creation of a Prescription … Continue Reading

Judge Overseeing Opioid Lawsuits Takes Unorthodox Approach

Ohio Judge Dan A. Polster, who is handling the multi-district opioid litigation proceedings, is taking a very active hand in the management of the proceedings before him, the New York Times reports.  His methods are unorthodox: calling for minimal discovery, rapid settlement (if possible), and real-world solutions to “clean up this mess.”  Judge Polster’s distinctive … Continue Reading

Think Your Prescription Drug Advertising is Beyond NAD’s Purview? NAD Disagrees.

Those of us who spend our days at the intersection of law and advertising of health products generally accept that the prescription drug world is a universe unto itself, overseen by the FDA pursuant to the Prescription Drug Marketing Act. As prescription drug companies have increased their direct-to-consumer outreach through social media, native advertising, and … Continue Reading

FDA & FTC Issue Joint Warning Letters to Companies Marketing Products to Overcome Opioid Addiction and Withdrawal

The FDA & FTC today posted warning letters to 11 marketers and distributors of opioid cessation products, alleging that such products were unapproved new drugs that violated the Federal Food, Drug and Cosmetic Act (FDCA) and that made unsubstantiated, deceptive claims in violation of the FTC Act.  In addition to the 11 joint warning letters … Continue Reading

AG Sessions Ends Obama-Era Policies Governing Federal Marijuana Enforcement; Sudden Wave of Enforcement Unlikely

Timed almost to the day that California legalized recreational marijuana, Attorney General Jeff Sessions announced on Thursday, January 4, that the Department of Justice has rescinded the Obama-era guidance (the Cole Memo) issued to federal prosecutors relative to marijuana enforcement. The announcement characterizes the move as an effort to restore prosecutorial discretion, noting that the … Continue Reading

Litigation Is Not The Solution To The Opioid Epidemic

The causes of the opioid epidemic are myriad and unique, and undermine the legal claims faced by manufacturers. Opioids are not tobacco, and pharmaceutical companies — who produce and distribute medicine that for many provide vital relief from chronic, agonizing pain — are not cigarette companies. Read our Law360 article discussing how the opioid crisis … Continue Reading

Preparing for the Opioid Litigation Epidemic

One of the newer symptoms of this so-called “Opioid Epidemic,” is a rash of litigation targeting pharmaceutical manufacturers and distributors. Currently, there are actions underway in Texas, West Virginia, Alabama, Ohio, Mississippi, South Carolina, Kentucky, Washington, Illinois, California, New York and more new suits are being filed. In each of these claims, specific acts and … Continue Reading

FDA and EPA Issue Joint Guidance On Jurisdiction Over Mosquito-Related Products

Last week, FDA and the EPA issued guidance for industry regarding each agency’s respective jurisdiction over mosquito-related products.  With the emergence of the Zika virus and the urgency in countering the spread of mosquito-borne diseases taking on new prominence, the agencies acknowledged that “novel mosquito control technologies have gained greater attention as an element of … Continue Reading

Dietary Supplement Advertising

Did you know Kelley Drye’s Advertising Law practice produces a newsletter, Dietary Supplement Advertising, to help marketers of dietary supplements stay out in front of regulatory challenges. Click here to access our Publication Sign Up and select Dietary Supplements to subscribe. Find contents from the latest issue below: Click here to view with images. STATE REGULATION State AGs and the New Administration … Continue Reading

DEA Expands Marijuana Manufacturing But Refuses to Reclassify Schedule I Drug

On Thursday, the DEA announced a policy change expanding the number of DEA-registered marijuana manufacturers producing marijuana for research.  This move is expected to expand and diversify the supply of marijuana for research use.  Under the current policy, the only authorized marijuana manufacturer is the University of Mississippi, which operates under a contract with the … Continue Reading

FDA Approves Genetically Engineered Atlantic Salmon as Safe and Effective for Human Food and Releases Related Draft Guidance on Voluntary Labeling

On Thursday, November 19th, the Food & Drug Administration (FDA) announced that it had approved an application for AquAdvantage Salmon, a type of Atlantic Salmon that has been genetically engineered to grow to market size more quickly than other salmon.  The agency regulates genetically engineered (GE) animals such as AquAdvantage Salmon under the new animal … Continue Reading

FDA Stays Final Guidance on INDs for Foods and Dietary Supplement Studies

On October 30, 2015, the U.S. Food and Drug Administration announced that it was staying portions of its controversial Final Guidance relating to the types of studies that require compliance with Investigational New Drug procedures.  The stay serves to encourage scientific research into the relationship between diet and health while FDA considers numerous comments questioning … Continue Reading

FTC Staff Comment Encourages FDA to Reevaluate its Current Approach to Regulating Homeopathic Products

On Friday, staff of the Federal Trade Commission’s Bureau of Consumer Protection, Office of Policy Planning, and Bureau of Economics submitted a written comment to FDA recommending that FDA reconsider its current regulatory framework to homeopathic drugs.  The comment responds to FDA’s March 27, 2015 announcement of a public hearing on the topic and request … Continue Reading

HHS Removes Extra Hurdle for Marijuana Research

The process for studying the potential medical benefits of marijuana became more streamlined on Tuesday, when the U.S. Department of Health and Human Services eliminated a controversial requirement for Public Health Service review of non-federally funded research protocols involving marijuana. Historically, in addition to the standard FDA and Drug Enforcement Administration approvals needed for research … Continue Reading

FDA’s Marijuana Q&A: More Questions than Answers?

The FDA recently released its current thinking on marijuana in a variety of forms in a web-based document titled “FDA and Marijuana: Questions and Answers.”  The most notable question and answer related to whether cannabidiol (“CBD”), a non-narcotic extract of industrial hemp, can be marketed as a dietary supplement, a position that was unclear following … Continue Reading

U.S.-China Commission Study Provides Policy Recommendations to Help U.S. Exporters Compete in China’s Growing Medical Device and Pharmaceutical Market

A recent report issued by the U.S.-China Economic and Security Review Commission (USCC)[1] highlights why the Chinese market is central to the business strategy of many U.S. companies that manufacture and market pharmaceuticals, medical devices, and other healthcare products.  The Congressionally-mandated report[2], issued in November 2014, addresses in detail the opportunities and challenges surrounding access to … Continue Reading

Sunscreen Innovation Act Changes FDA Review Process for More Than Just OTC Sunscreens

On November 26, 2014, the President signed into law the Sunscreen Innovation Act (Pub. L. No. 113-195).  The Act is primarily intended expedite FDA procedures for approving new sunscreen active ingredients and ingredient blends for use in nonprescription sunscreen products under the Federal Food Drug and Cosmetics Act, and address the current backlog of sunscreen … Continue Reading

FDA on UGC

A recent warning letter suggests that FDA, in regulating user generated content (“UGC”) on social media pages, will likely treat all companies the same. Earlier this year, FDA released two guidance documents for drug and medical device companies on social media. Those documents provided the following stance on UGC: “[A] firm generally is not responsible for UGC … Continue Reading

FDA Releases Social Media Guidance for Promotion of Prescription Drug and Medical Device Products

Recently, FDA released two draft guidance documents on the promotion of prescription drugs and medical devices on the Internet and social media platforms.  The long-awaited guidance provides recommendations for firms that choose to correct misinformation disseminated by independent third parties and to promote their products on space-constrained platforms, such as Twitter or sponsored ads.  Comments … Continue Reading

FDA Holds Hearing on OTC Drug Review Process; Accepting Comments Until May 12

On March 25 and 26, FDA’s Center for Drug Evaluation and Research (CDER) held a public hearing to obtain input on the over-the-counter (OTC) drug review process.  Under the OTC Drug Review, FDA was able to determine, by therapeutic category, that  thousands of OTC drug products were generally recognized as safe and effective (GRAS/E).  FDA … Continue Reading
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