Tag archives: pharmaceuticals

COVID-19 Update: Pfizer vaccine fully approved by FDA

Photo of Yvonne Puig (US)Photo of Daphne Andritsos Calderon (US)Photo of Hannah Putnam (US)By Yvonne Puig (US), Daphne Andritsos Calderon (US) and Hannah Putnam (US) on Posted in Coronavirus, FDA & Food Safety
On August 23, 2021, the US Food and Drug Administration (“FDA”) granted full approval for the Pfizer-BioNTech COVID-19 (“Pfizer”) vaccine for individuals sixteen-years-old and older. This change shifts the vaccine from emergency-use only and is the first COVID-19 vaccine granted approval by the FDA in the United States. For individuals aged twelve through fifteen, the … Continue reading

Litigation trends in life sciences and pharmaceuticals: What you need to know

Photo of Allison Lange Garrison (US)By Allison Lange Garrison (US) on Posted in General
A team of Norton Rose Fulbright pharma and medical-device litigators recently presented to the Life Sciences and Healthcare Spring Webinar Series on “Pharma Delivers: Now What?” Pharmaceutical companies delivered pandemic-ending vaccines, and are rewarded with an increasingly positive public reputation. The presenters forecasted how this public-opinion bump might impact future litigation, and more broadly discussed … Continue reading

House Subcommittee on Health holds hearing on 340B program

Photo of Thomas Dowdell (US)By Thomas Dowdell (US) on Posted in News from DC
On July 11, the U.S. House of Representatives Energy and Commerce Subcommittee on Health held a hearing on the 340B program, entitled “Opportunities to Improve the 340B Drug Pricing Program.” In his opening statement, Subcommittee Chairman Michael Burgess (R-TX) stated that it is reasonable to review the 340B program because healthcare has “evolved significantly” since … Continue reading

Recent effort to regulate pharmaceutical pricing deemed unconstitutional by Fourth Circuit

Photo of Robin Adelstein (US)By Robin Adelstein (US) on Posted in Enforcement, FDA & Food Safety, News from DC, Regulatory
In the absence of federal action, states have attempted to rein in high pharmaceutical pricing by enacting laws aimed at regulating drug pricing. Following what now has become a trend, on March 13, 2018, Oregon became the newest state to enact such legislation, The Prescription Drug Price Transparency Act, H.B. 4005. But many of these … Continue reading

Ontario introduces legislation requiring disclosure of payments to physicians

Photo of Ian Trimble (CA)Photo of Sara Zborovski (CA)By Ian Trimble (CA) and Sara Zborovski (CA) on Posted in International
Following a consultation, legislation was introduced in the Ontario Legislature on September 27, 2017 that will require pharmaceutical and medical device manufacturers to disclose financial relationships to healthcare professionals and organizations. The Health Sector Payment Transparency Act is one of several acts introduced by Bill 160. It will require manufacturers, wholesalers, marketing firms, and others … Continue reading

FTC and DOJ side with Texas-based Teladoc

Health Law PulseBy on Posted in Regulatory
The Federal Trade Commission (“FTC”), in a joint amicus brief with the Department of Justice filed on September 9, 2016, petitioned the Fifth Circuit to dismiss the Texas Medical Board (“TMB”) appeal of the district court ruling holding that TMB regulations restricting the prescribing rights of physicians providing professional services through telemedicine may be challenged … Continue reading

FDA now demands its strongest black box warnings for certain opioid and other drugs

Photo of Yvonne Puig (US)Photo of Mark Faccenda (US)By Yvonne Puig (US) and Mark Faccenda (US) on Posted in FDA & Food Safety
On August 31, 2016, the U.S. Food and Drug Administration (“FDA”) announced class-wide drug labeling changes aimed at providing better information to health care providers and patients. FDA’s guidance warns of the risks associated with combined use of certain opioid medicines and benzodiazepines. FDA prepared a Drug Safety Communication directed to health care professionals and … Continue reading

Judge declines to certify order for appeal in Texas Teladoc case

Health Law PulseBy on Posted in Regulatory
On August 15, 2016, United States District Judge Robert Pitman denied the motion of the Texas Medical Board (“TMB”) to certify order for an immediate appeal of the court’s decision not to dismiss the Teladoc case.  The court previously denied the TMB’s attempt to have the case against it dismissed, which was brought by Teladoc … Continue reading

Administrative dispute resolution process is proposed to resolve 340B drug pricing program disputes

Photo of Thomas Dowdell (US)By Thomas Dowdell (US) on Posted in Regulatory
On August 11 the Health Resources and Services Administration (HRSA) issued a notice of proposed rulemaking (RIN 0906-AA90) that would implement an administrative dispute resolution (ADR) process that would apply to all drug manufacturers and covered entities that participate in the 340B drug pricing program. The rule if implemented as proposed will establish and implement … Continue reading

2015 CMS “Open Payments” data released

Photo of Benjamin Wallfisch (US)By Benjamin Wallfisch (US) on Posted in Transparency
Last week, CMS posted the 2015 Open Payments data to its website, as well as updated payment records for 2013 and 2014.  Overall, manufacturers reported $7.52 billion in payments and ownership interests to 618,931 physicians and 1,116 teaching hospitals in 2015.  Nearly 1,500 companies reported making payments in 2015, comprising a total 11.9 million records.  … Continue reading

New ethical guidelines from the AMA: Telemedicine

Photo of Frances Morgan (US)By Frances Morgan (US) on Posted in Regulatory
On June 13, 2016, the American Medical Association (AMA) at its annual meeting approved new ethical guidelines for physicians providing telemedicine services, which will be incorporated in the full publication of the AMA Code of Medical Ethics this fall. Although the ethical guidelines do not place legal limitations on the provision of telemedicine for any … Continue reading

Senators urge HHS to further expand patient access to opioid drug treatment

Photo of Yvonne Puig (US)Photo of Mark Faccenda (US)By Yvonne Puig (US) and Mark Faccenda (US) on Posted in News from DC, Regulatory
On March 30, 2016, the Secretary of the Department of Health and Human Services (HHS) published a proposed rule to expand access to medication-assisted treatment (MAT) by allowing certain eligible practitioners to treat up to 200 patients, as authorized under the Controlled Substances Act.  MAT involves the use of medication in combination with certain behavioral … Continue reading

Australia: Review of pharmaceutical reimbursement rules

Photo of Bernard O'Shea (AU)Photo of Rohan Sridhar (AU)By Bernard O'Shea (AU) and Rohan Sridhar (AU) on Posted in International
Background On 25 April 2015, the Minister for Health announced a review of the Guidelines (Guidelines) for Preparing Submissions to the Pharmaceutical Benefits Advisory Committee (PBAC), the body that recommends which products should be reimbursed by Government, and for how much.  The Minister said the review sought to ensure that the PBAC Guidelines are “consistent … Continue reading

House passes comprehensive opioid legislation in advance of negotiations with the Senate

Photo of Yvonne Puig (US)Photo of Mark Faccenda (US)By Yvonne Puig (US) and Mark Faccenda (US) on Posted in News from DC, Regulatory
During the week ending May 13, 2016, the U.S. House of Representatives approved a comprehensive set of 18 bills aimed at curbing the opioid epidemic. The largest of these bills, the Comprehensive Opioid Abuse Reduction Act of 2016 (H.R. 5046), passed by a 413-5 vote in the House on May 12, 2016.  This bill authorizes … Continue reading

Australia – nicotine and therapeutic goods

Photo of Bernard O'Shea (AU)Photo of Rohan Sridhar (AU)By Bernard O'Shea (AU) and Rohan Sridhar (AU) on Posted in FDA & Food Safety
A recent Australian case (http://www.austlii.edu.au/au/cases/cth/FCA/2016/394.html) has touched on the tricky area of nicotine containing products, this time in the guise of product known as the Voke Inhalator, which contained 0.43mg of nicotine in a pressurised inhalation can.  The supplier of the product was seeking to register the product as an OTC product, but our regulator, … Continue reading

Australia: Victoria creates new medical cannabis regime – children with epilepsy first to have access

Health Law PulseBy on Posted in FDA & Food Safety
The use of cannabis for restricted medical purposes is set to be legalised in Victoria following the passing of the Access to Medicinal Cannabis Bill 2015.  The Bill creates a new legal regime that regulates the cultivation, manufacture and supply of cannabis in Victoria, and allows for specified categories of patients to have access to … Continue reading

FDA issues Data Integrity Guidance under CGMP

Photo of Savannah Wiseman (US)By Savannah Wiseman (US) on Posted in FDA & Food Safety
Increasing concerns about data integrity in the pharmaceutical industry have prompted the U.S. Food and Drug Administration (“FDA”) to release Draft Guidance addressing the issue as it relates to current good manufacturing practices (cGMP) for pharmaceutical companies. The Draft Guidance – titled Data Integrity and Compliance with CGMP, Guidance for Industry – is framed a … Continue reading

FDA establishes bright-line recommendations for human drug compounding

Photo of Yvonne Puig (US)Photo of Mark Faccenda (US)By Yvonne Puig (US) and Mark Faccenda (US) on Posted in FDA & Food Safety
On April 15, 2016, the U.S. Food and Drug Administration (FDA) released three draft guidance documents addressing human drug compounding under the Federal Food Drug, and Cosmetic Act (FDCA). FDA issued new policies concerning the prescription requirement under section 503A of the FDCA, human drug compounding in hospitals and health systems, and the facility definition … Continue reading

Paxil birth defect lawsuit cannot survive exclusion of evidence of later FDA warnings

Health Law PulseBy on Posted in Enforcement
Last week, the first of nine Paxil birth defect lawsuits in line for trial in Pennsylvania was dismissed after a judge excluded evidence of the drug’s later heightened FDA warning. Judge Kenneth Powell of the Philadelphia County Court of Common Pleas granted a compulsory nonsuit in favor of defendant GlaxoSmithKline PLC (“GSK”) after portions of … Continue reading
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