Category Archives: Drugs

Subscribe to Drugs RSS Feed

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FDA Approves Genetically Engineered Atlantic Salmon as Safe and Effective for Human Food and Releases Related Draft Guidance on Voluntary Labeling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

Bulk Drug Importer Sues FDA For Refusing Entry of 20,000-Kilogram API Shipment

Recently, H&M USA, an importer of  periodic bulk shipments of active pharmaceutical ingredients (API) turned to the courts in an effort to gain relief when the company’s efforts to resolve an unexpected import detention through FDA’s administrative process proved unsuccessful.  The FDA issued a Notice of Refusal, alerting the company that it had failed to … Continue Reading

FDA Releases Draft Guidance on Unique Facility Identifier (UFI) System for Drug Establishment Registration

FDA announced this week the availability of the draft guidance, “Specification of the Unique Facility Identifier (UFI) System for Drug Establishment Registration.” The draft guidance would implement sections 701 and 702 of the Food and Drug Administration Safety and Innovation Act (FDASIA) by specifying that domestic and foreign drug manufacturers should use the Data Universal … Continue Reading

Supreme Court Ruling Increases Likelihood of Future Antitrust Challenges in Drug Patent Cases

On June 17, 2013, the Supreme Court issued its decision in FTC v. Actavis, Inc. et al. Justice Breyer delivered the majority decision, and was joined by Justices Kennedy, Ginsburg, Sotomayor, and Kagan. Chief Justice Roberts dissented, together with Justices Scalia and Thomas. Justice Alito was recused from the decision. This decision increases the likelihood … Continue Reading

Ninth Circuit Rejects First Amendment Defense In Wire Fraud Case Regarding Drug Misbranding

This is a follow-up to our post late last year on the Second Circuit decision in US v. Caronia, which overturned a defendant’s off-label marketing conviction on First Amendment grounds (see our December 10, 2012 post, “Second Circuit Overturns Off-Label Marketing Conviction On First Amendment Grounds”). In United States v. Harkonen, the Ninth Circuit rejected … Continue Reading

Bill to Expand Reporting of Antimicrobial use in Food Animals Introduced

On February 26, 2013, Energy and Commerce Committee Ranking Member Henry A. Waxman and Rules Committee Ranking Member Louise M. Slaughter introduced H.R. 820, the Delivering Antimicrobial Transparency in Animals (DATA) Act. The DATA Act would amend the federal Food Drug and Cosmetic Act to require sponsors of antimicrobial drugs to submit annual reports for … Continue Reading

IOM Report on Counterfeit Drugs Released

On February 13, 2013, the Institute of Medicine of the National Academies (IOM) released its report Countering the Problem of Falsified and Substandard Drugs. The report identifies causes and recommends strategies to address the problem of substandard and falsified drugs. The IOM first distinguishes public health concerns of falsified and substandard drugs from the intellectual … Continue Reading

Heightened FDA Activity Related to OTC Drugs Expected in 2013

According to the 2013 unified agenda for the Department of Health and Human Services, FDA plans to recommend several changes to U.S. OTC drug labeling, safety monitoring, and manufacturing standards in 2013 which may impact future marketing and product development strategies for consumer products. Forthcoming FDA proposals include the following:  Proposed Monograph Modifications  Amending the … Continue Reading

FDA Annonunces Generic Drug User Fees

On January 16, 2013, the Food and Drug Administration (FDA) announced the rate for the generic drug active pharmaceutical ingredient (API) and finished dosage form (FDF) facilities user fees for fiscal year (FY) 2013. The Federal Food, Drug, and Cosmetic Act (FDCA) as amended by the Generic Drug User Fee Amendments of 2012 (GDUFA) authorizes … Continue Reading

Second Circuit Overturns Off-Label Marketing Conviction On First Amendment Grounds

Applying the First Amendment in a way that could significantly alter the prosecutorial and regulatory landscape in Food and Drug cases, the United States Court of Appeals for the Second Circuit has overturned the conviction of a pharmaceutical sales representative for conspiring to introduce a misbranded drug into interstate commerce, where his prosecution and conviction … Continue Reading

Health Orgs Release Joint Statement on Antibiotic Resistance

The Center for Disease Control (CDC), joined by 25 other American health groups, released a Joint Statement on Antibiotic Resistance. The Joint Statement was released as part of the CDC’s Get Smart About Antibiotics Week, an effort launched in 2008 to educate the public about antibiotic overuse and antibiotic resistance. Get Smart About Antibiotics Week … Continue Reading
LexBlog