Tag Archives: FDA

FDA’s Draft Guidance For Industry On Pre-Launch Activities Importation Requests: Dead On Arrival?

On July 25, 2013, the Food and Drug Administration (“FDA” or “the Agency”) published a Draft Guidance for Industry entitled “Pre-Launch Activities Importation Requests”, or “PLAIR”. The draft guidance describes FDA policy on requests for importation of unapproved finished dosage form drug products by an applicant preparing for market launch pursuant to a New Drug … Continue Reading

A Short-Lived Victory for Generic Drug Manufacturers?

By Peter S. Reichertz On June 24, 2012, the U.S. Supreme Court handed down its decision in Mutual Pharmaceutical Co. Inc. v. Bartlett, 570 U.S. ____ (2013), finding that design-defect claims against generic drug companies are pre-empted where federal law prohibits an action required by state law. The Supreme Court had previously held in Pliva v. Mensing, 564 … Continue Reading

FTC v. Actavis: What Does It Mean for Reverse-Payment Settlements?

On June 17, 2013, the United States Supreme Court announced a rule that blurs the lines between antitrust and patent law in the context of Hatch-Waxman litigation. In FTC v. Actavis, 570 U.S. 756 (2013), the Federal Trade Commission (“FTC”) prevailed when the Supreme Court held in a 5-to-3 decision [1] that reverse payment settlements … Continue Reading

Cybersecurity: FDA Risks for Medical Devices

On Thursday, June 13, 2013, the U.S. Food and Drug Administration (“FDA”) released a draft guidance on measures to help ensure the cybersecurity of medical devices. The draft guidance, titled “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices,” proposes cybersecurity features that should be incorporated into wireless, Internet- and network-connected medical devices … Continue Reading

Ninth Circuit Off-Label Marketing Decision Suggests More Prosecutions Will Be Coming

The Ninth Circuit has reopened a door for off-label marketing prosecutions, and it is important to review your compliance and risk management programs in light of this recent decision. Last December, the pharmaceutical and medical device industries exhaled a sigh of relief in response to the influential Second Circuit’s decision in United States v. Caronia, holding … Continue Reading

The Impact of Cloud Computing on FDA’s Regulation of Medical Products

The following blog article is drawn from the upcoming book Cloud Computing Deskbook, which is set to be released by Thomson Reuters West next summer. Cloud Computing Deskbook covers the legal and regulatory aspects of cloud computing, including those related to regulation by U.S. Food and Drug Administration. Please contact the author with any questions related to FDA … Continue Reading

FDA Issues Final Guidance on Filing PMAs and 510(k)s

On December 31, 2012, the U.S. Food and Drug Administration (FDA) issued two new guidance documents on the minimum threshold of acceptability for medical device premarket submissions, which are titled “Refuse to Accept Policy for 510(k)s,” and “Acceptance and Filing Reviews for Premarket Approval Applications (PMAs).” These guidance documents detail the conditions under which a … Continue Reading

FTC Proposes Amendments to the Premerger Notification Rules to Expand the Reportability of Transfers of Exclusive Patent Rights in the Pharmaceutical Industry

On August 13, 2012, the Federal Trade Commission (“FTC”) proposed amendments to the Premerger Notification Rules issued under the Hart Scott Rodino Antitrust Improvements Act of 1976 (the “HSR Act”). The proposed amendments would expand when a transfer of exclusive rights to a patent in the pharmaceutical industry is potentially reportable under the HSR Act.… Continue Reading

The Uncomfortable Resurgence of the Responsible Corporate Officer Doctrine

By Mike Emmick and Joseph Barton Corporate executives in the health care and environmental industries are rapidly coming to appreciate the implications of the responsible corporate officer doctrine, a recently-revitalized weapon in U.S. Department of Justice’s battle against corporate crime. This doctrine is a peculiar exception to the usual requirements for a criminal prosecution. Ordinarily, … Continue Reading

FDA Announces Proposals for Biosimilars User Fees and Performance Review Goals

By Peter Reichertz FDA has at last began formal implementation of the Biologics Price Competition and Innovation Act of 2009 ("BPCI Act"), by announcing the proposal it will send to Congress to implement user fees for "generic" copies of biologics, called biosimilars in the BPCI Act. A biosimilar is a product approved under Section 351(k) … Continue Reading

Institute of Medicine Report: Dead on Arrival

By Seth A. Mailhot On Friday, July 29, 2011, the Institute of Medicine of the National Academies (IOM) released its long awaited report on the premarket clearance process under section 510(k) of the Federal Food Drug and Cosmetic Act.[1] The premarket clearance submission, commonly known as a 510(k), allows manufacturers to market a medical device … Continue Reading

FDA Announces Its Plan For Changes to the 510(k) “Approval” Pathway

By Peter S. Reichertz and Allie Frumin January 19, FDA announced its plan to modify the 510(k) “approval” pathway, the most common review path for medical devices. Specifically, FDA released a report containing twenty-five actions it intends to take in 2011 to “improve” the review process. Importantly, however, no changes have yet been made to the process; … Continue Reading

E-CIGARETTES GET A “SMOKING” BREAK: D.C. Circuit Clarifies Scope of FDA’s Authority Over E-Cigarettes

By Deborah M. Shelton and Allie Frumin On Tuesday December 7th, the D.C. Circuit Court of Appeals affirmed a lower court’s ruling in Sottera, Inc. v. FDA, No. 10-5032, (D.C. Cir. Dec. 7, 2010) holding that that the Food and Drug Administration (FDA) could not regulate as a medical device the electronic cigarettes (often referred … Continue Reading

FDA Announces Much Anticipated Public Hearing on Biosimilars

By Deborah M. Shelton Having had the opportunity to analyze the biosimilars provisions of the new health care law enacted this past March, stakeholders have at long last the chance on November 2-3 to weigh in on FDA’s implementation of the biosimilar approval pathway. FDA will hold a two-day public hearing on November 2-3, 2010, from … Continue Reading

FCC And FDA Focused On Convergence Of Communications And Medical Systems

By Peter S. Reichertz, Brian D. Weimer and Daniel Brooks Last week, the Federal Communications Commission ("FCC") and the Food and Drug Administration ("FDA") launched a joint initiative to clarify the approval process and regulatory requirements for converged communications and health care devices. In a two-day joint meeting held on July 26-27, 2010, the two agencies … Continue Reading

FDA’s Regulation of Laboratory Developed Tests (LDTs) – Changes on Horizon?

By Deborah M. Shelton For years, the Food and Drug Administration has maintained that it has jurisdiction over laboratory-developed tests (“LDTs”) – those in vitro tests developed, validated and used for in-house pathology and diagnostic purposes – as medical devices. Yet the Agency has, with some few exceptions (e.g., IVDMIAs), exercised enforcement discretion, reasoning that … Continue Reading

Elimination of Customs Duties Possible for Over 700 Additional Pharmaceutical Products and Chemical Intermediates

By Peter S. Reichertz By letter dated May 27, 2010, the U.S. Trade Representative (“USTR”) sent a letter to the U.S. International Trade Commission (“ITC”) requesting that the ITC provide information about over 700 pharmaceutical products and chemical intermediates for which the elimination of custom duties may be proposed. As part of the “zero-for-zero” initiative of … Continue Reading

The FDA Transparency Initiative: Another One Way Street?

By Peter Reichertz On May 19, 2010, FDA published on its website a series of proposals designed to promote “openness” and “transparency” in government. The document, entitled “FDA Transparency Initiative: Draft Proposals for Public Comment Regarding Disclosure Policies of the United States Food and Drug Administration” can be found here.  The document contains 21 specific proposals about changing … Continue Reading

New Taxes for Pharmaceutical and Medical Device Manufacturers/Importers/Distributors

By Peter Reichertz Manufacturers As part of the recently enacted Patient Protection and Affordable Care Act (“PPACA”) – known to most as Healthcare Reform Legislation, new taxes will be imposed on manufacturers of “branded prescription drugs” and most medical devices. These taxes are in addition to the fees already charged by the Food and Drug Administration … Continue Reading
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