Archives: Legislative Developments

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Proposed 21st Century Cures Act Addresses Off-Label Promotion Issues for Drugs and Devices

Over on the Health Industry Washington Watch blog, Reed Smith attorneys Katie Pawlitz and Jeremy Alexander highlight the proposed changes to the Sunshine Act contained within H.R. 6, the “21st Century Cures Act,” which (as previously reported on Life Sciences Legal Update) was approved by the House Energy and Commerce Committee last Thursday, May 21, … 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

21st Century Cures Markup Underway; Offsets Released

Today the House Energy and Commerce Committee is marking up H.R. 6, the 21st Century Cures Act, a high-profile, bipartisan bill that seeks to accelerate the pace of medical cures in the United States through a variety of reforms addressing drug and device development and approval, clinical trial design, research funding, interoperability of health technology, … Continue Reading

Bipartisan Energy & Commerce Committee Leaders Release Updated 21st Century Cures Draft

The bipartisan leadership of the House Energy and Commerce Committee has released their 2015 version of the 21st Century Cures Act, which is intended to bolster medical discovery, treatment development and delivery of treatment to patients. The nearly 200-page legislation is the product of a year-long collaboration between lawmakers and stakeholders.… Continue Reading

Amidst Increasing Security Concerns, Medicare to Drop Social Security Numbers from Cards

Last week, President Obama signed into law a bill that will eradicate Social Security Numbers (SSNs) from all Medicare beneficiary cards over the next eight years. Medicare has four years to begin issuing cards with new identifiers, and four years after that to reissue cards to current beneficiaries. The removal of SSNs from the cards is not only expected to decrease the risks associated with identity theft for Medicare beneficiaries, but also Medicare's risk of exposure associated with breaches of protected health and personal information under HIPAA and state privacy laws.… Continue Reading

MACRA Signed into Law by President; Reforms Medicare Payment Policy for Physician Services

On April 16, 2015, President Barack Obama signed into law the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). The bill permanently transforms the structure of Medicare physician reimbursement and enacts several changes to Medicare payment, program integrity and policy provisions that will affect both health care providers and pharmaceutical/medical device manufacturers. The most … Continue Reading

Toward Class Actions for Health-Related Claims in France

The French government issued a bill on March 17 for the extension of class actions to health-related claims in France. Starting today, March 31, the text will be discussed at the French National Assembly, particularly to address the issue of compensation for personal injury within the framework of the proposed class action.… Continue Reading

In-House Lawyers in France Remain without Legal Privilege

French Minister for Economic Affairs Emmanuel Macron recently introduced a bill proposing the recognition of legal privilege for in-house lawyers in France, which does not currently exist. However, this recognition was rejected by the Special Commission of the French National Assembly before the bill was passed by the lower chamber - a decision consistent with the Grand Chamber of the European Court of Justice's 2010 ruling in Akzo.… Continue Reading

U.S. Congressional Committees Address Drug And Device Approval

As mentioned on our Health Industry Washington Watch blog, committees in both the House of Representatives and Senate last week addressed the speed at which medical innovations are approved and available for patient use. The House Energy and Commerce Committee’s “21st Century Cures Act” discussion draft, released on January 27, 2015, is a wide-reaching bill … Continue Reading

Drug Disposal Ordinance: Supreme Court Writ Filed

The Pharmaceutical Research and Manufacturers of America (PhRMA), the Biotechnology Industry Organization (BIO), and the Generic Pharmaceutical Association (GPhA) have jointly filed a Petition for a Writ of Certiorari with the U.S. Supreme Court, asking for review of the Ninth Circuit's decision in PhRMA v. County of Alameda, in which the court ruled that Alameda County's Safe Drug Disposal Ordinance - requiring pharmaceutical manufacturers to establish or participate in a program for collecting unwanted prescription drugs from consumers - was constitutional.… Continue Reading

New Jersey Enacts Data Privacy Law for Health Insurance Carriers

New Jersey Governor Chris Christie has signed a law requiring health insurance carriers in that state to encrypt individuals' personal information. This new law will be enforced in conjunction with the New Jersey Consumer Fraud Act (NJCFA), and failure to obey the law will be classified as a violation of the NJCFA, which could result in financial penalties for the carriers. The new legislation may also affect business associates through the contractual terms of business associate agreements.… Continue Reading

County Ordinances Place Responsibility for Collection of Unwanted Pharmaceuticals on Manufacturers

The Alameda County (CA) Safe Drug Disposal Ordinance (Alameda County Code Chapter 6.53, §§ 6.53.010-6.53.120) is one of several county-wide regulations across the United States to enforce the establishment of and/or participation in Product Stewardship Plans on the part of pharmaceutical manufacturers, with the ultimate goal of collecting unwanted drugs for purposes of disposal. The … Continue Reading

Omnibus Spending Bill Promises Increased Funding for Ebola Response in FY 2015

On December 16, 2014, President Obama signed into law an omnibus spending bill that will provide funding across the federal government in the remainder of FY 2015. The bill includes $5.4 billion designated for several regulatory agencies - including the Centers for Disease Control and Prevention, Department of Defense, Food and Drug Administration, Department of Health and Human Services, National Institutes of Health and Department of State - to use in response to the Ebola epidemic, on both a national and international scale.… Continue Reading

Proposed HELP Committee Bill Aims to Incentivize Development of Ebola Treatments and Vaccines

In light of the recent Ebola outbreak and concerns over health safety, members of the U.S. Senate’s Health, Education, Labor, and Pensions (HELP) Committee have introduced a bill that would add Ebola to the Food and Drug Administration’s (FDA) priority review voucher program, which is designed as an incentive for developers of treatments and vaccines … Continue Reading

Innocent Co-Insureds Coverage Not Void Under Fake Doctor’s Application

Reed Smith’s Policyholder Perspective blog recently posted about an October 21, 2014 ruling in the U.S. District Court in South Carolina that sounds as if it came from a Hollywood film. In Evanston Insurance Company v. Agape Senior Primary Care, et al., 2014 WL 5365679, the court held that despite a false application for professional … Continue Reading

New California Amendment Aims to Increase Breach Responsibility and Accountability

A recently enacted law in California is designed to expand the scope of requirements for entities that own, license, and maintain data or information about a resident of the state. This amendment to the California Civil Code, scheduled to go into effect on January 1, 2015, was passed in the wake of several recent high-profile security breaches at such retailers as Target, Neiman Marcus, and The Home Depot.… Continue Reading

Law360 Article – U.S. and French Sunshine Laws Present Compliance Challenges for Manufacturers

In “From Sea to Shining Sea: French and US Sunshine Laws,” (Law360 subscription required), Reed Smith attorneys Elizabeth Carder-Thompson and Daniel Kadar discuss recent legislation from both sides of the Atlantic designed to increase the transparency of relationships between drug and medical device manufacturers on one hand and physicians and teaching hospitals on the other. … Continue Reading

UK Government Addresses Lack of Regulation and Legislation in Cosmetics Industry

In April 2013, an independent review of the regulation of cosmetic interventions in the UK was published, highlighting an insufficient amount of regulation in this industry by the UK government, due in part to the rapid growth of cosmetic procedures in the United Kingdom. Cases such as unauthorized (and potentially defective) materials being used in … Continue Reading

A Comparison of the U.S. and French Sunshine Reporting Requirements

This past year both the U.S. and France enacted substantial new reporting and disclosure requirements under their respective Sunshine Acts, which were designed to increase the transparency of the financial relationships between manufacturers and health care professionals and to allow patients to make more informed decisions regarding their health treatments. The U.S. and French Sunshine … Continue Reading

Something to Give Up for the New Year: Pennsylvania Hospitals May Forgo Some DOH Licensure Reviews

With the arrival of 2014, the Pennsylvania Department of Health ("DOH") is now authorized to grant "deemed status" for licensure purposes to hospitals that have been accredited by national accreditation organizations, such as The Joint Commission. This past July, Governor Corbett signed Act 60 of 2013 ("Act 60") into law, which amends the Health Care Facilities Act to require DOH to accept hospital surveys and inspections conducted by national accreditation organizations designated as acceptable to DOH in lieu of DOH's regular licensure renewal surveys. In addition, Act 60 extends the term of licensure from two years to three years for all Pennsylvania hospitals.… Continue Reading

Supreme Court Decision on Reverse Payments has Significant Implications for Pharmaceutical Manufacturers

Reed Smith’s Global Regulatory Enforcement Law Blog recently featured a detailed analysis of the Supreme Court’s decision in FTC v. Actavis, where the court ruled five-to-three that reverse payments, also called pay-for-delay settlements, can violate antitrust laws and are subject to antitrust review under the rule-of-reason. As reverse payments are commonly used by branded drug … Continue Reading

Supreme Court Decides Mutual Pharmaceutical Co. v. Bartlett

As reported on Drug and Device Law Blog, in a five-to-four decision by Justice Alito, the Supreme Court has decided Mutual Pharmaceutical Co. v. Bartlett, No. 12-142, slip op. (U.S. June 24, 2013), a generic drug preemption case out of the First Circuit where that court had permitted the plaintiffs to recover on a “design defect” … Continue Reading

Seeing the Light With the Physician Payment Sunshine Act

This post was written by Karl A. Thallner Jr. and Katie C. Pawlitz. On February 1, 2013, the Centers for Medicare & Medicaid Services released the long-awaited final rule implementing the physician payment transparency provisions, commonly referred to as the Physician Payment Sunshine Act, in the Obama administration’s 2010 health care reform legislation. The Sunshine … Continue Reading
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