Category: Bioethics & Clinical Research
Ethical Issues Surrounding Noncompliance in Organ Donation
Within a few months of the controversial lung donation to a child who was placed on the adult organ donation waiting list by way of a judge’s ruling, the media has been buzzing about yet another controversial case.
15-year old Anthony Stokes received a heart transplant at Children’s Healthcare of Atlanta on August 20. Anthony had originally been denied a spot on the heart transplant list due to his noncompliance, one of the medical center’s contraindications for being listed for a heart transplant. Apparently, a doctor told Anthony’s family that his “history of noncompliance” related to his low grades and time spend in juvenile detention. A week later, Anthony’s doctors and the hospital reversed their decision, giving him top priority on the transplant list.
Anthony began having chest pain this summer, which led to his admission to the hospital and ultimate diagnosis … Read More »
CMS Issues Sunshine Act FAQs
CMS recently issued an FAQ clarifying one of the most puzzling questions regarding implementation of the Sunshine Act reporting requirements: whether manufacturers must report transfers of value (“TOVs”) to non-physician employees of teaching hospitals. CMS’s answer is that “[n]on-physician employees of a teaching hospital and non-physician employees of a physician-owned practice or other physician-owned entity are not covered recipients for the purposes of [the Sunshine Act regulations]. Accordingly, payments or other transfers of value made to these non-physician employees generally do not need to be reported.” However, CMS added, the TOV would be reportable if the employer requested that the manufacturer make the TOV to the employee, or if the manufacturer designated that the TOV was made on behalf of the employer. In addition, CMS added that if the manufacturer makes a TOV to a non-physician employee, requiring, instructing or directing that it be passed on … Read More »
Organ Transplantation in Children: What is Ethical?
New ethical questions have been spurred by the recent lung transplantation case involving a 10-year old girl from Pennsylvania. Sarah Murnaghan, who was diagnosed with cystic fibrosis, had been fighting for her life, ever since her grim prognosis. While she was able to work her way up to the top of the donor list for children, 18 months later, the lungs she needed were still nowhere to be found. With her condition worsening over the beginning of this year, she was in desperate need of a transplant, and her parents were running out of options to find a solution.
That is when Sarah’s parents began to question the Organ Procurement and Transplant Network’s Policy 3.7.6, indicating that any child under the age of 12 cannot receive priority for deceased adult donor lungs. Backing up a step, to take a look at the … Read More »
French Sunshine Act Implemented…Awaiting Guidance
As pharmaceutical and device manufacturers and others are scrambling to finalize interpretations and implementation of the U.S. Physician Payment Sunshine Act, the French government added to the activity by releasing similar transparency regulations. On May 22, 2013, the French Ministry of Health published Decree No. 2013-414, implementing the French Sunshine law, which was enacted on December 29, 2011 and is known as the Bertrand law, after the French Minister of Health, Xavier Bertrand. The compliance date was set for June 1, 2013, and reporting is retroactive to January 1, 2012, giving companies a mere 10 days to interpret the regulations and compile and report data. It is expected that a Circular (i.e., guidance document) interpreting the Decree will be released soon.
The French Sunshine law requires reporting by companies that produce, market, or provide services associated with products listed in a particular … Read More »
Robyn Shapiro talks about conflicts of interest at MAGI East 2013
Robyn Shapiro spoke in Boston on May 7th at the MAGI East conference. Robyn’s presentation focused on how to deal with conflicts of interest in an evolving landscape. Her review of the Sunshine Rule and its implications in clinical trials and research opened up a lively discussion of how sponsors and researchers can approach this challenging development in regulation
Proposed New Requirements on FDA Acceptance of Data from Clinical Studies for Medical Devices
On February 25, 2013, the FDA proposed new regulations to amend its current requirements on the acceptance of clinical data for medical devices. Specifically, the FDA is proposing to amend its acceptance criteria for data from clinical studies outside of the United States used as support for an investigational device exemption (IDE) application, a premarket notification (510k) submission, a premarket approval (PMA) application, a product development protocol (PDP), or a humanitarian device exemption (HDE) application, by requiring that such studies be conducted in accordance with good clinical practice (GCP) standards. In addition, the proposed rule seeks to amend the 510(k), HDE, and IDE requirements for FDA acceptance of data from clinical studies conducted inside the United States to parallel existing FDA requirements for PMA applications. Should these proposed requirements ultimately become final, medical device manufacturers will need to ensure that their clinical … Read More »
CMS’s Final “Sunshine” Rule: Implications for Research
On February 1, 2013, the Centers for Medicare and Medicaid Services (CMS) released its long-awaited final rule (Final Rule) implementing Section 6002 of the Patient Protection and Affordable Care Act (ACA), commonly known as the “Physician Payment Sunshine Act” (Sunshine Act or Act).[1] The Sunshine Act was included in ACA to enhance disclosure and transparency of financial arrangements among physicians, teaching hospitals, and manufacturers of certain products (federally reimbursable drugs and biologicals as well as covered medical devices and medical supplies), and thereby reduce the risk of inappropriate financial incentives interfering with medical judgment and patient care. The Final Rule details requirements for processing and reporting payments by pharmaceutical, device, biological, and medical supply “applicable manufacturers”[2] to physicians and teaching hospitals that are “covered recipients.”[3] The Final Rule also sets forth requirements for reports of ownership and investment interests held … Read More »
HIPAA/HITECH Omnibus Final Rule: Implications for Research
The Department of Health and Human Services’ HIPAA/HITECH Omnibus Final Rule (Final Rule) includes a number of provisions that will alleviate certain restrictions and administrative burdens in human subjects research and help streamline the documentation associated with research. Here are the significant changes:
Compound Authorizations
The current HIPAA Privacy Rule generally prohibits “compound authorizations,” which are authorizations for use and disclosure of protected health information (PHI) that are combined with any other legal permission. An exception to this general prohibition permits combining an authorization for use and disclosure of protected health information in a research study with any other written permission for the same study, including an informed consent to participate in the research. However, until March 26, 2013, the effective date of the Final Rule, even the same study exception is unavailable if one of the authorizations or permissions conditions treatment, … Read More »
Massachusetts Refines Its Sunshine Law; Final Federal Sunshine Regulations Moving Ahead
The relationship between health care providers and drug and device manufacturers has been a focus of lawmakers at both the federal and state level. While we continue to await final federal regulations implementing the Physician Payment Sunshine Act (federal Sunshine Act), which generally requires disclosure of financial arrangements among physicians, teaching hospitals, and drug and device manufacturers,[1] Massachusetts has refined its requirements governing relationships between physicians and drug and device manufacturers. Amendments to the Massachusetts Pharmaceutical and Medical Device Manufacturer Code of Conduct regulations[2] (the Massachusetts Regulations) broaden the scope of permissible meals and refreshments that may be provided by manufacturers to health care practitioners and clarify issues related to preemption of the Massachusetts Regulations by the federal Sunshine Act. The Massachusetts changes and impending release of final federal regulations underscore the continuing need for drug and device manufacturers to … Read More »
Are Biosimilars the Next Generation of Small Drug Manufacturers?
New reports suggest that while generic drug makers are aggressively consolidating in the United States and United Kingdom, smaller generic drug manufacturers’ viability is threatened, forcing them to seek niche therapeutic areas. Manufacturing biosimilar biologicals may be an answer for the smaller generic drug companies, due to several factors. First, while manufacturing complexities create market entry barriers, recent shortages of the biologics supply in the U.S. have increased the market demand. Also, low margins are causing large manufacturing companies to exit the biologics market. Furthermore, the patents for many top selling biologics will expire in the next 3 to 5 years, creating an opportunity for new market entrants. Finally, the new abbreviated approval pathway for biosimilars in the U.S. may be more conducive to the needs of smaller firms: efficient approval process, lower development costs, and protection for first generation biologics.
Background
In … Read More »