Tag Archives: Legislation

HIPAA/HITECH Compliance Strategies for Medical Device Manufacturers

As computing power continues to become cheaper and more powerful, medical devices are increasingly capable of handling larger and larger sets of data. This provides the ability to log ever expanding amounts of information about medical device use and patient health. Whereas once the data that could be obtained from a therapeutic or diagnostic device … Continue Reading

Will an FDA Rule Make People Sick? – FDA Establishes a Rule on the Labeling of “Gluten Free” Foods that Sets a Limit Above What Some Groups Claim Causes Adverse Reactions

On August 5, 2013, the U.S. Food and Drug Administration published a final rule on the labeling of foods as “gluten free.”[1] Gluten is a protein composite found in wheat, rye, barley, and their crossbred hybrids. Gluten gives elasticity to dough, helping it rise and keep its shape and often gives the final product a … Continue Reading

A Short-Lived Victory for Generic Drug Manufacturers?

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 U.S. … Continue Reading

Thoughts on Regulatory Constraints of Business Models

I am often called upon to address the nature of how regulatory controls may apply to the organization of healthcare companies in their ability to create, deliver, and capture value (their ‘business models’). While no summation could adequately capture all of the complexity inherent in this question, it would seem appropriate to briefly comment on … 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 … Continue Reading

FDA Issues Two Proposed Rules That Will Significantly Change Regulatory Requirements For Food Safety

By Peter Reichertz, Seth Mailhot, and Robert Uram The FDA Food Safety Modernization Act (FSMA), which was signed into law by President Obama on January 4, 2011, proposes the most sweeping reform of U.S. food safety laws in more than 70 years. As part of the changes introduced by the law, Section 103 of FSMA, titled “Hazard Analysis … Continue Reading

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

By Seth A. Mailhot and Peter S. Reichertz 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 … Continue Reading

Proposition 37 Permits “Natural” Labeling for Non-GMO Processed Food

Proposition 37, the California Right to Know Genetically Engineered Food Act ("Prop 37”), if approved by the voters on November 6, 2012, will provide that food offered for retail sale in California produced with genetic engineering (“GMO food”) is misbranded unless clearly labeled to say it is genetically engineered. Prop 37 also provides that GMO … Continue Reading

Comment Period to Close On Petition to FDA for Mandatory Labeling of All Foods Produced Using Genetic Engineering

By Robert Uram On March 27, 2012, the comment period will close on a petition filed by the Center for Food Safety that calls for the FDA to issue new regulations requiring labeling of all foods produced using genetic engineering (GE). Docket No. FDA-2011-P-0723 (Filed October 12, 2011). Unlike many other developed countries – such … 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

Rights to Compensation for use of Biospecimens: OHRP and FDA Clarify that Waivers of Rights in Informed Consents are not “Exculpatory”

By Peter S. Reichertz In a Federal Register notice of September 7, 2011,[1] the Office of Human Research Protection (“OHRP”) and the Food and Drug Administration have clarified that a waiver by an individual in an informed consent to compensation for use of his/her biospecimens is not “exculpatory”, and permissible, if worded properly. This Guidance – … Continue Reading

Generic Drug Manufacturers And Failure To Warn: What duty is there after Pliva v. Mensing?

By Peter S. Reichertz The Supreme Court ruled on June 23, 2011, that generic drug manufacturers cannot be sued for a failure to warn under state tort law, as long as their labeling complies with the FDA mandated labeling for the innovator drug product. While the Court had previously declined to find that federal regulation and … Continue Reading

Sunscreen in the Spotlight: FDA Illuminates New Sunscreen Regulations

By Seth A. Mailhot and Allie Frumin On June 14, 2011 the U.S. Food and Drug Administration (FDA) announced new requirements for sunscreens and sunscreen-containing products currently sold over-the-counter. These changes are covered in a Federal Register notice to be published on June 17, 2011. The Final Rule will have a significant impact on producers of sunscreens and cosmetics … Continue Reading

A MATRIXX Revolution, Part II: Supreme Court affirms Ninth Circuit’s holding that life science companies cannot rely on a statistical significance standard when deciding whether adverse event reports are material for the purpose of securities disclosures

By Peter S. Reichertz and Allie Frumin On March 22, the U.S. Supreme Court affirmed the Ninth Circuit’s ruling in Matrixx Initiatives, Inc. v. Siracusano, 09-1156. See our prior blog article from November 18, 2010.  … 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

IRS Guidance On New Excise Tax On Branded Pharmaceutical Companies: Filing Due January 21, 2011

By Peter S. Reichertz In a prior article dated May 25, 2010, we advised of a new excise tax on branded pharmaceutical manufacturers. We indicated that the Patient Protection and Affordable Care Act ("PPACA") required the Internal Revenue Service ("IRS") to publish guidance "necessary to carry out the purpose" of the section in which the tax … Continue Reading

A MATRIXX Revolution? Is there a need to describe all adverse event reports in SEC filings of life sciences companies?

By Peter S. Reichertz The U.S. Supreme Court has scheduled oral argument for January 10, 2011, in the case of Matrixx Initiatives et al v. Siracusano, Case Number 09-1156, on appeal from the decision of the Ninth Circuit in Siracusano v. Matrixx Initiatives, Inc., 585 F3d 1167 (9th Cir. 2008).  The court granted certiorari on … Continue Reading

FTC Changes Guidance on Environmental Marketing Claims

By Robert L. Magielnicki Many marketers of OTC drugs and devices, cosmetics, foods and dietary supplements make claims with regard to the content of their products and/or the packaging for their products. and their fate in or effect on the environment. These claims are regulated by the Federal Trade Commission (“FTC”) and its “false and misleading” … Continue Reading

Has the Time Come for “Total Recall” of Medical Products?

By Peter Reichertz On July 14, 2010, Congressman Edolphus Towns introduced legislation to provide for the mandatory recall of adulterated or misbranded drugs. The legislation, H.R. 5740, has been referred to the Committee on Energy Commerce. Congressman Towns was the chair of the subcommittee that held hearings about Johnson & Johnson/McNeil and its handling of adulterated children’s drug … Continue Reading
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