Don't bank just yet on putting your marketing muscle behind the safe and effective off-label uses of your FDA-approved drugs, or defending your next mass consumer class action on First Amendment grounds. But you can start giving those multi-billion dollar prospects some serious thought, because constitutional winds are blowing through the Code of Federal Regulations ...
Minister of Health Regulation No. 30 of 2013 on The Inclusion of Information on Sugar, Salt, and Fat Content, and Health Impact Messages for Processed and Fast Foods is aimed at lowering the exposure of the public to the risk of non-contagious disease such as hypertension, stroke, diabetes and heart attacks, which can be caused by the excessive consumption of processed or fast foods ...
The Minister of Health has issued Regulation No. 28 of 2013 on Affixing Health Warnings and Information on Tobacco Product Packaging which came into force on 12 April 2013, as a further implementation of Government Regulation No. 109 of 2012 on Control of AddictiveSubstances in the Form of Tobacco Products. The Regulation requires tobacco producers and importers to affix pictorial health warnings and health information on their tobacco products packaging ...
The Head of the National Drug and Food Control Agency (Badan Pengawas Obat dan Makanan – “BPOM”) recently issued Regulation No. 27 of 2013 on The Supervision of Drugs and Food Imports into Indonesian Territory which came into effect on 28 May 2013. This Regulation repeals and replaces the previous regulations on Imports of Processed Foods, Cosmetics and Drugs ...
In Novozymes A/S v. DuPont Nutrition Biosciences APS, 2012-1433 (Fed. Cir. July 22, 2013), the Federal Circuit affirmed the district court’s grant of DuPont’s post-trial motion for judgment as a matter of law holding that Novozymes’ U.S. Patent No. 7,713,723 (“the ’723 patent”), directed to a variant of alpha-amylase, was invalid under 35 U.S.C. § 112, first paragraph, for failing to satisfy the written description requirement.2 (Slip op. at 18) ...
BackgroundFollowing much anticipation on the part of health care industry members, CMS released its long-awaited final rule on the Physician Payment Sunshine Act in February 2013, supplying clarification and guidance on new financial disclosure requirements governing pharmaceutical and medical device manufacturers. The rule includes extensive and potentially time-consuming mandates for drug and device companies, including reporting of annual payments to physicians and teaching hospitals ...
Never has there been a more controversial law in the past decade than the Reproductive Health Law (“RH Law”). After a long and contentious battle in Congress, the law was finally passed. But the fervent opposition by the so-called Pro-life groups (chief among them the Catholic Church) endures. Four days after the approval of the law’s Implementing Rules and Regulations (“IRR”), the Supreme Court on March 19, 2013, halted its implementation, issuing a 120-day status quo ante order ...
When does title in the ship pass from the shipbuilder to the shipowner? Can the parties agree to change when title will pass? Usually shipbuilding contracts are negotiated on standard forms such as the SAJ form produced by the Shipbuilders’ Association of Japan and the AWES form produced by the Association of European Shipbuilders and Shiprepairers. South African law generally recognises freedom of contract and accordingly parties to a contract are entitled to vary the terms by agreement ...
In a statement issued by the National Regulatory Agency, Control and Surveillance (ARCSA), drugs that are sold in Ecuador must have labels stating the words 'generic', otherwise it can not be marketed as of January 24, 2014 ...
On October 18, 2013, the Centers for Medicare & Medicaid Services (CMS) published Survey & Certification Letter 14-01-NM, which clarified the obligations of a skilled nursing facility (SNF) or nursing facility (NF) (collectively “nursing homes”) to provide cardiopulmonary resuscitation, or CPR, to its residents ...
The Colombian government, aware of the need to improveinfrastructure in order to reduce logistical costs and thereby promote the country’s growth and development, is currently in the process of selecting contractors for the fourth generation road concessionprogram, which envisages the award of approximately 25 concession contracts, with total investment of close to €18,300 million ...
Physician-owned distributorships (PODs) and other physician-owned entities (POEs) have emerged as a favored vehicle to reduce costs, but the popularity of PODs and POEs has led to increased scrutiny by federal regulators. In June 2011, the United States Senate called on the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) and Centers for Medicare & Medicaid Services to investigate the proliferation of PODs and corresponding utilization practices ...
The Swedish court of appeal (hovrätten över Skåne och Blekinge) decided in May this year that the party ordering a transport service also is liable for payment of such service; regardless of if the parties have agreed that the receiver of the goods or any other party shall be the receiver of the invoice. In this case a seller of goods has agreed with a carrier that the freight should be invoiced the receiver of the goods ...
In one of the few decisions of its kind, the UK High Court recently assessed the damages to be paid to a generic pharmaceutical company under a cross-undertaking in damages. While some aspects of the decision are specific to the UK pharmaceutical reimbursement scheme, the judgment will be a useful reference point for parties involved in similar litigation in Australia ...
The Advance Payments Code provides a protection mechanism for local highway authorities to ensure that they are not unexpectedly required to meet the costs of new roads that were not intended to be maintained by the public purse. A local highway authority can serve a notice seeking the payment of, or security for, the estimated cost of construction for the private streets in a development (an APC Notice) ...
As you no doubt already know, the Pharmaceutical Industry in Argentina is a strictly controlled industry. Said control is held by the ANMAT Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) and it spreads from the first authorisation of a laboratory to act as such in the country, moving through the authorisations to commercialise products, up to pharmacovigilance of products that have already been commercialised ...
On April 1, 2014, the Superior Court issued an interesting decision respecting consent to care1. The Quebec City CHU petitioned the Superior Court in order to be authorized to provide care for a 60‑day period to a patient despite the refusal of her parents. On March 14, the 22 years old patient suffered cardiac arrest following an intravenous drug overdose ...
Regional governments in Sweden are increasingly looking to leverage their purchasing power in order to secure discounts and rebates on the list prices of branded drugs. However, as noted by Elizabeth Eklund, Partner at leading commercial law firm Delphi, such agreements risk running foul of both Swedish and European Union (EU) law ...
The healthcare industry will have to wait for a court to answer the question of whether the United States Federal Trade Commission (the “FTC”) has authority to regulate data security practices of entities covered by the Health Insurance Portability and Accountability Act (“HIPAA”). On Monday, a federal district judge dismissed LabMD, Inc.’s case without reaching the merits, declining to disrupt the underlying administrative proceeding ...
LabMD, Inc. renewed its argument that the FTC lacks authority to regulate the data security practices of HIPAA covered entities by appealing the dismissal of its case for lack of jurisdiction (see our coverage here) to the Eleventh Circuit. LabMD also filed an emergency motion seeking expedited briefing and requesting an order enjoining the administrative proceedings until the appellate court rules on the merits of its argument ...
The United Arab Emirates (the UAE) was established in 1971 as a Federation of the Emirates of Abu Dhabi, Dubai, Sharjah, Ajman, Umm Al Quwain and Fujeirah. In 1972 the Emirate of Ras Al Khaimah joined the Federation, with the result that the UAE presently comprises the seven named Emirates. The UAE is strategically located on the northeastern tip of the Arabian Peninsula, having its shores along the Arabian (Persian) Gulf and the Gulf of Oman where it joins the Arabian Sea ...
This year marks the 30th anniversary of the passage of the Hatch-Waxman Amendments to the Federal Food, Drug and Cosmetic Act (FD&C Act). Considered to be one of the most successful pieces of legislation ever enacted, the Hatch-Waxman Amendments created the modern generic drug industry, which is responsible for dramatically increasing the availabilty of low-cost generic drugs and saving the U.S. healthcare system billions of dollars ...
On July 16, 2014, the Sixth Circuit Court of Appeals confirmed that a “health care provider can bring the Medicare Secondary Payer Act’s (“MSP’s”) private cause of action against a non-group health plan that denies coverage for a reason besides Medicare eligibility.” In Michigan Spine & Brain Surgeons, PLLC v. State Farm Mutual Automobile Insurance Co., the Court clarified a key holding in its prior decision in Bio-Medical Applications of Tennessee, Inc. v ...
