Archives: Regulatory Developments

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FDA Files Brief Regarding Off-Label Promotion In Amarin Pharma Lawsuit

As we mentioned in our prior post, the Amarin Pharma, Inc. v. United States Food and Drug Administration lawsuit pending in the Southern District of New York raises interesting issues regarding the First Amendment and how it applies to speech by drug and device manufacturers regarding “off-label” uses.  As we noted, on June 8, 2015, … Continue Reading

FCC Ruling Clarifies Ambiguities in the TCPA

For years  industry groups have been petitioning the Federal Communications Commission (FCC) to clarify ambiguities in the Telephone Consumer Protection Act (TCPA), which make it difficult for businesses to comply and leave them vulnerable to litigation. Finally, on June 18, 2015, the FCC responded. As discussed in a Client Alert by Reed Smith attorneys Judith … Continue Reading

FDA Sued By Drug Manufacturer Over Constitutional Right To Discuss Off-Label Uses

This post was written by Evelien Verpeet The FDA has long sought to ban manufacturers from promoting off-label uses of approved drugs and medical devices.  In taking the position that manufacturers and their agents cannot promote off-label uses, the FDA suggests they are safeguarding the public from misbranded medical products and ensuring that manufacturers do … Continue Reading

Texas Legislature Passes Two Bills Affecting Personal Injury And Wrongful Death Litigation

Two bills recently passed by the 84th Texas Legislature, HB 1692 and SB 735 have the potential to affect businesses at risk of personal injury and wrongful death litigation in Texas.  Intended to curb the practice of foreign plaintiffs filing claims in Texas courts for personal injuries occurring outside state borders, HB 1692 would change … Continue Reading

U.S. Supreme Court Ruling Addresses Wartime Tolling of Statute of Limitations Under False Claims Act

On May 26, the U.S. Supreme Court issued its ruling in Kellogg Brown & Root Services, Inc. v. United States ex rel Carter, No. 12-1497, __ S. Ct. __ (2015), in which a relator brought civil False Claims Act (FCA) claims against government contractors. The relator alleged that the contractors had made fraudulent payment claims … Continue Reading

The Continuing Evolution of the French Sunshine Act

Since the general disclosure rule for provider-manufacturer relationships in France was enacted into law on January 1, 2012, its compliance and enforcement have been a common point of discussion for health care professionals, pharmaceutical and medical device manufacturers, and government officials, among others. As Reed Smith partner Daniel Kadar points out in “The French Sunshine … Continue Reading

OIG Report: FDA Has Made Progress on Oversight/Inspections of Manufacturers of Generic Drugs

On May 5, the Office of Inspector General (OIG) issued a report entitled "FDA Has Made Progress on Oversight and Inspections of Manufacturers of Generic Drugs" in response to a Congressional request expressing concerns about the safety and quality of generic drugs produced by manufacturers outside the United States. The OIG report contains an analysis of FDA's inspections of generic drug manufacturers over the past several years, and provides several recommendations for the FDA going forward.… Continue Reading

FDA Releases Draft Guidance on Acceptance of Medical Device Clinical Data from Studies Conducted Abroad

The Food and Drug Administration (FDA) has issued a notice announcing the availability of a draft guidance document clarifying its acceptance of medical device clinical data from studies conducted in countries other than the United States. The document is intended to provide guidance regarding the 2012 Food and Drug Administration Safety and Innovation Act § 1123, amending Food, Drug & Cosmetic Act § 569B, which codified FDA's policy of accepting scientifically-valid clinical data obtained from non-U.S. clinical studies in support of premarket submissions for medical devices.… Continue Reading

FDA, CMS Form Interagency Task Force on LDT Quality Requirements

FDA and CMS have announced that they are establishing an interagency task force to reinforce their collaboration regarding the oversight of laboratory-developed tests (LDTs) - tests intended for clinical use and designed, manufactured, and used within a single lab. According to an FDA blog post, the goals of the FDA/CMS task force include identifying areas of similarity between the FDA quality system regulation and requirements under the Clinical Laboratory Improvement Amendments (CLIA); working together to clarify responsibilities for laboratories that fall under the purview of both agencies; and leveraging joint resources to avoid duplication and maximize efficiencies.… Continue Reading

CMS Discusses Medicare Implications of FDA Approval of First Biosimilar Product

CMS has issued an educational article on the FDA's approval of the first biosimilar product, and what implications this approval will have for Medicare coverage. CMS plans to ensure that Medicare beneficiaries will have access to this new product, as it does for other drugs that receive FDA approval. The CMS article addresses several questions that have arisen regarding biosimilars.… Continue Reading

Erroneous Country of Origin Determinations May Result in Significant FCA Penalties for Medical Device Companies

Country of origin labeling issues can be exceedingly complex, as we have noted before. Several manufacturers have recently paid multi-million dollar settlements for alleged misstatements about their products’ country of origin, under the Trade Agreements Act (TAA) and False Claims Act (FCA). As described by Reed Smith attorneys Larry Sher, Larry Block and Jeffrey Orenstein … Continue Reading

State Attorneys General Address Data Privacy and Security Issues

State attorneys general across the United States have taken recent action towards addressing data privacy and security issues. In Connecticut, the attorney general announced the establishment of a Privacy and Data Security Department to handle investigations and litigation relating to data privacy and security. This month's National Association of Attorneys General (NAAG) Southern Region Meeting featured presentations on big data, cybersecurity, cloud computing and data breaches, and next month's NAAG presidential initiative summit will address topics such as intellectual property theft, cloud computing and digital currency. Finally, Washington's attorney general has proposed several amendments to expand the scope of that state's data breach notification requirements.… Continue Reading

French Sunshine Act’s Scope Expands with Recent French Supreme Administrative Court Decision

Reed Smith’s Global Regulatory Enforcement Law Blog features a post on a recent decision by the French Supreme Administrative Court (Conseil d’Etat) that expands the scope of the French Sunshine Act. “French Supreme Administrative Court Decision Significantly Broadens the Scope of the French Sunshine Act,” written by Reed Smith attorneys Daniel Kadar and Caroline Gouraud, … Continue Reading

The SEC and the Pharmaceutical Industry – Recent Commentary by the SEC’s Enforcement Director Identifies Areas of SEC Focus Applicable to the Industry

Andrew Ceresney, enforcement director of the U.S. Securities and Exchange Commission (SEC), recently gave a presentation at CBI's Annual Pharmaceutical Compliance Congress in which he highlighted three current areas of SEC focus most relevant to the pharmaceutical industry: the Foreign Corrupt Practices Act, corporate disclosures relating to interactions with the Food and Drug Administration, and financial internal controls.… Continue Reading

Court of Federal Claims Decision on Contracts Regulations Reversed on Appeal

Earlier this week, the Court of Appeals for the Federal Circuit reversed and remanded the Court of Federal Claims’ August 2014 decision in CGI Federal Inc. v. The United States, in which the Court of Federal Claims ruled that the Centers for Medicare and Medicaid Services (CMS) could include contract clauses that deviated from federal … Continue Reading

FDA Draft Guidance Addresses Electronic Informed Consent in Clinical Investigations

FDA has issued a draft guidance providing recommendations for clinical investigators, sponsors and institutional review boards on the use of electronic informed consent for FDA-regulated clinical investigations of medical products, including drugs, medical devices and biological products. FDA is accepting comments on the draft guidance until May 8, 2015. In addition, the HHS Office for Human Research Protections (OHRP) is considering whether to adopt the positions and recommendations proposed in this guidance for research regulated under the HHS protection of human subjects regulations and to issue a joint OHRP/FDA guidance document on this topic once the FDA's final guidance document has been developed.… Continue Reading

Recent Regulatory Actions on Advertisement Disclosures

An article in Compliance Week discusses recent actions by the Federal Trade Commission (FTC) and Food and Drug Administration concerning advertisement disclosures. The FTC launched Operation Full Disclosure in fall 2014, which involved sending warning letters to more than 60 companies across "a wide range of industries" for failing to properly disclose information in their advertisements. These letters serve as a reminder to all companies, even those that did not receive letters, to review their disclosures in order to minimize the likelihood of a violation in the future.… Continue Reading

FDA Releases Planning Board’s Report on National Medical Device Postmarket Surveillance System

FDA has released the Medical Device Postmarket Surveillance System Planning Board’s report, Strengthening Patient Care: Building an Effective National Medical Device Surveillance System, which outlines recommended steps toward achieving the National Medical Device Postmarket Surveillance System (MDS) and strategies for implementation. For more information, see http://blogs.fda.gov/fdavoice/index.php/2015/02/moving-toward-a-national-medical-device-postmarket-surveillance-system/.… Continue Reading

Public Consultation Examines Potential Confidentiality Issues with New European Clinical Trial Regulations

Since January 21, the European Medicines Agency (EMA) has been holding a public consultation on the new European Clinical Trial Regulations (CTRs), which are intended to streamline the application process for clinical trials and increase the availability of information and results. However, the CTRs have met with some concerns regarding commercial and patient confidentiality. As … Continue Reading

Insurance Coverage Considerations for Alleged Mislabeling of Herbal and Dietary Supplements

In the wake of the New York Attorney General's recent enforcement actions against four major retailers who allegedly sold herbal supplements that did not contain labeled ingredients or contained ingredients not explicitly identified on the labels, companies throughout the supply chain should consider examining their insurance policies to see whether or not they are sufficiently covered in the event of an investigation, enforcement action and/or litigation. Types of insurance policies that may provide coverage for affected companies are commercial general liability (CGL), directors and officers liability (D&O), errors and omissions liability (E&O), and product recall.… Continue Reading

False Advertising Claims & The First Amendment

The U.S. Court of Appeals for the District of Columbia Circuit ruled on January 30th that the Federal Trade Commission can prohibit POM Wonderful LLC from making the advertising claim that its products can help in fighting afflictions and ailments such as heart disease, prostate cancer and erectile dysfunction. The appeals court also decided that POM Wonderful requires the support of one clinical trial before it can make any subsequent claims that its products are effective in fighting disease. POM Wonderful had maintained that its advertisements and claims are protected under the First Amendment, a position that was rejected by the appellate court's decision.… Continue Reading

Federal Trade Commission Fines Manufacturers of Weight Loss Supplement $9 Million for Alleged Deceptive Advertising

The Federal Trade Commission (FTC) voted to fine two manufacturers of green coffee bean extract $9 million for making claims that consumers could lose body weight and fat by using the extract. The FTC alleges that the manufacturers' advertised claims were deceptive and the result of a flawed research study. However, two dissenting FTC commissioners believe that the amount of the fine was excessive because it took into account sales attributed to televised statements that were constitutionally protected and non-commercial in nature.… Continue Reading

FTC Offers Privacy and Security Guidance for Medical Devices in ‘Internet of Things’ Report

On January 27, the Federal Trade Commission (FTC) issued a 71-page Staff Report on privacy and security issues with the Internet of Things (IoT) - the growing ability of everyday devices to monitor and communicate information through the Internet. The Staff Report - which follows up on the FTC's public workshop over concerns with the IoT, as well as the FTC's first enforcement action brought in September 2013 - is especially relevant in the life sciences industry, which may see potentially revolutionary advances as a result of the IoT.… Continue Reading
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