Category Archives: Drugs

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FDA Releases Draft Guidance on Unique Facility Identifier (UFI) System for Drug Establishment Registration

FDA announced this week the availability of the draft guidance, “Specification of the Unique Facility Identifier (UFI) System for Drug Establishment Registration.” The draft guidance would implement sections 701 and 702 of the Food and Drug Administration Safety and Innovation Act (FDASIA) by specifying that domestic and foreign drug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

FDA Issues Phthalate Draft Guidance For Pharmaceutical Products

In early March, the Food and Drug Administration (FDA) issued draft guidance recommending that the “pharmaceutical industry avoid the use of [dibutyl phthalate (DBP)] and [di(2-ethylhexyl) phthalate (DEHP)] in [Center for Drug Evaluation and Research (CDER)]-regulated drug and biologic products,” including prescription and nonprescription products, because of “potential human health risks associated with exposure to … Continue Reading

Where in the World is FDA? FDA Submits Report to Congress on Foreign Programs as Required by FSMA

The Food and Drug Administration (“FDA”) has submitted its Report to Congress on the FDA Foreign Offices. Under the Food Safety Modernization Act (FSMA), FDA is required to update Congress on the agency’s progress in establishing foreign posts and working with foreign government counterparts to further FDA’s mission. Companies that import food, drugs, devices or … Continue Reading

FDA Notification Allows Entities to Continue Making Coronary Heart Diseases Claims that Exceed the Scope of Claims Permitted by the FDA’s Interim Final Rule

On February 21, 2012, the Food and Drug Administration (“FDA”) published a notification extending the time period for which the FDA intends to exercise enforcement discretion concerning the use of health claims for phytosterols and the risk of coronary heart disease (“CHD”) based on factors set forth in a 2003 letter regarding CHD claims.  This … Continue Reading

FDA Expands Scope of Reporting for Discontinued Drugs

The FDA has published an interim final rule amending definitions related to required notifications regarding drug shortages. 21 C.F.R. 314.81(b)(3)(iii) requires an applicant who is the sole manufacturer certain approved drug products to notify FDA in writing at least 6 months prior to discontinuing manufacture of the drug product. 21 C.F.R. 314.81(b)(3)(iii) now refers to … Continue Reading

FDA makes “Quantitative Summary of the Benefits and Risks of Prescription Drugs: A Literature Review” available for comment

On December 13, 2011, FDA announced the availability of a draft report entitled “Quantitative Summary of the Benefits and Risks of Prescription Drugs: A Literature Review” for public comment. The literature review was conducted pursuant to section 3507(a) of the Patient Protection and Affordable Care Act (Affordable Care Act) which required the Secretary of Health … Continue Reading

FDA Proposes “Experimental Study of Comparative Direct-to-Consumer Advertising”

On December 9, 2011, the Food & Drug Administration (FDA) issued a notice announcing that a proposal to collect information for a “Experimental Study of Comparative Direct-to-Consumer Advertising” had been submitted to the Office of Management and Budget (OMB). FDA is required to submit the proposal to OMB for review and clearance under the Paperwork … Continue Reading

FDA Notice Clarifies Past Federal Preemption Policy Statements

The Food and Drug Administration (“FDA”) recently completed an evaluation of the legal basis for federal preemption policy statements the agency has issued under the Federal Food, Drug & Cosmetic Act (“FDCA”) during the past 10 years. FDA initiated the review in response to a memorandum issued by President Obama in May 2009 which directed … Continue Reading

Supreme Court Rules on Generic Drug Labeling Preemption

On June 23, 2011, the Supreme Court rendered its decision in Pliva, Inc. v. Mensing holding that FDA regulations governing generic drug products directly conflict with and preempt state laws that would require generic drug manufacturers to modify the FDA-authorized labeling for their products to provide “adequate warnings” as defined by state law. The Court … Continue Reading

Hold the Tweets: Why Marketers of Consumer Health Products Should Watch For FDA’s Policy on Social Media

The Food and Drug Administration (FDA) is expected to issue guidance and possibly regulations regarding use of social media. These policies will only be enforceable on marketers of prescription drugs and restricted medical devices; however, industry can expect that the rationale and policy behind the guidance and regulations will apply across the board to consumer … Continue Reading

Can We Say That? A Practical Guide to Substantiating Claims for Food and Consumer Health Products

This Monograph, published by the Food and Drug Law Institute, is designed to assist lawyers, regulatory advisors and marketing professionals answer the question "Can we say that?" as they design and execute programs to promote consumer health products such as foods, dietary supplements, non-prescription drugs and medical devices, cosmetics and pet care products. It serves … Continue Reading
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